{"ID":108204,"post_author":"26","post_date":"2023-06-23 14:51:39","post_date_gmt":"2023-06-23 18:51:39","post_content":"","post_title":"LIMSpec for Cannabis Testing","post_excerpt":"","post_status":"publish","comment_status":"closed","ping_status":"closed","post_password":"","post_name":"limspec-for-cannabis-testing","to_ping":"","pinged":"","post_modified":"2023-06-23 15:00:17","post_modified_gmt":"2023-06-23 19:00:17","post_content_filtered":"","post_parent":0,"guid":"https:\/\/www.limsforum.com\/?post_type=ebook&p=108204","menu_order":0,"post_type":"ebook","post_mime_type":"","comment_count":"0","filter":"","holland":null,"_ebook_metadata":{"enabled":"on","private":"0","guid":"520C0C98-C9EC-471B-8E20-0F68182ABEC2","title":"LIMSpec for Cannabis Testing ","subtitle":"","cover_theme":"nico_20","cover_image":"https:\/\/www.limsforum.com\/wp-content\/plugins\/rdp-ebook-builder\/pl\/cover.php?cover_style=nico_20&subtitle=&editor=Shawn+Douglas&title=LIMSpec+for+Cannabis+Testing+&title_image=https%3A%2F%2Fs3.limsforum.com%2Fwww.limsforum.com%2Fwp-content%2Fuploads%2FGreenChemicals.jpg&publisher=LabLynx+Press","editor":"Shawn Douglas","publisher":"LabLynx Press","author_id":"26","image_url":"https:\/\/s3.limsforum.com\/www.limsforum.com\/wp-content\/uploads\/GreenChemicals.jpg","items":{"db94e5424bc12b5bfc776047de49fec8_type":"article","db94e5424bc12b5bfc776047de49fec8_title":"Putting LIMSpec for Cannabis Testing to use","db94e5424bc12b5bfc776047de49fec8_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Putting_LIMSpec_for_Cannabis_Testing_to_use","db94e5424bc12b5bfc776047de49fec8_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Putting LIMSpec for Cannabis Testing to useFrom CannaQAWikiJump to navigationJump to searchContents \n\n1 Putting those requirements to practical use \n\n1.1 Software developer considerations \n1.2 Buyer considerations \n\n1.2.1 Software vendor selection \n\n\n\n\n2 Caveats \n3 LIMSpec in Microsoft Word format \n4 References \n\n\n\nPutting those requirements to practical use \nHeavily based on the existing LIMSpec on LIMSwiki, this LIMSpec for Cannabis Testing covers laboratory informatics requirements for a cannabis testing laboratory. The requirements are organized into five broad categories, which are heavily influenced by the functional requirements checklist and Figure 3 of ASTM E1578-18 Standard Guide for Laboratory Informatics. However, the requirements listed prior are all based on not just the ASTM E1578 standard but also a wide variety of other standards, regulations, guidance documents, and standardized procedures (here on out referred to as \"sources\"). That ultimately means a foundational reasoning is provided for almost every requirement, not necessarily a \"just because I want it\" reasoning. However, as described in Chapter 1, the cannabis testing laboratory has a few specific requirements. As it turns out, many of those requirements\u2014e.g., third-party system integration\u2014are already baked into the original LIMSpec. Yet a few are not, and those requirements\u2014typically not supported by an existing standard or regulation\u2014have been added. In total, all these requirements provide an excellent starting point for building your own software requirements specification or for researching the best laboratory informatics solution for your cannabis testing laboratory. After all, not all informatics systems are equal, and that includes the various offerings of cannabis testing laboratory information management system (LIMS) vendors.\nSoftware developer considerations \nWhat does that mean for you? How can you best use this document? If you're a software developer for the cannabis testing industry, many of the sources referenced in these requirements should already be familiar to you. However, some of them may not be, and you'll probably want to at least familiarize yourself with them. Definitely review the requirements items listed throughout the entire document and make sure they are part of your own software requirements specification. In a few rare cases, a requirement may not make sense for your offering, and that's likely OK, as long as the requirement isn't regulatory-driven. How your business chooses to implement the resulting software requirements is also up to your business. However, keep software development standards and internal quality control in mind.\n\nBuyer considerations \nIf you're a potential buyer of a cannabis testing informatics solution, this LIMSpec for Cannabis Testing is also useful to you. Perhaps you know a bit about your laboratory's workflow and a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed. Reviewing the five broad categories of requirements may be necessary to help further inform you regarding what's vital in regards to what a laboratory informatics solution should be capable of. Additionally, you can then use these requirements as a base for your laboratory's own requirements list. \nAfter reviewing all the various requirements, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by this specification. However, do read the wording carefully, and especially be familiarized with Chapter 1 and its take on requirements specific to cannabis testing; it will map those industry-specific requirements to existing LIMSpec items. As you review the various requirement options available to you and narrow down your own needs, your list of requirements can be used as both a personal checklist and as a requirements list you hand over to the vendor you query.\n\nSoftware vendor selection \nThat said, the requirements you hand off to the vendor should be discussed a bit more. Software vendor selection can at times be a tedious yet necessary process, one which requires careful planning and best practices. This topic has been written about by both software developers and end users alike, and their experiences should play a role in how you select a vendor. What follows is bullet-pointed advice as offered by some of those developers and end users.[1][2][3][4][5][6][7][dead link] [8]\n\nHave a clear business case and build your business needs into your laboratory's requirements.\nBe mindful of how detailed you get with your own business-based requirements and what you initially hand off to a vendor. If you're too specific with too many requirements, you may have trouble finding a vendor that matches up. Start with the essentials that involve your laboratory's processes, regulations, integrations, reporting, service needs, etc. As this cannabis testing LIMSpec is foundation-based, you have a good starting point in that regard. You can always get more detailed with requirements as you narrow down vendors.\nAs discussed briefly in the introduction, you'll need to prioritize your needs somewhere between \"critical\" and \"nice to have.\" These requirements are largely critical for most purposes and can be marked as such. The requirements you add will have to be prioritized more carefully.\nYou'll also want to perform some informal third-party information gathering about the vendors. Are reviews of the vendors trustworthy? Have peers had any interactions and success with the vendor? Does the vendor have the ability to scale to meet your needs?\nSchedule demonstrations of programs that seem like strong initial candidates. Make sure there is a question and answer session afterwards, and perform a post-demo evaluation.\nA formal request for proposal (RFP) may or may not be necessary, depending on the level of information you acquire prior. However, formally requesting pricing and clarification of maintenance and additional service costs is useful. Just don't let price be the only thing that guides you.\nConsider some of the intangibles. Does the vendor genuinely seem interested in your business and its needs? Do they communicate well and promptly? Do they seem flexible and able to accommodate a few special case requirements?\nBe sure to consider future needs as you anticipate potential laboratory expansion, particularly into other nutraceutical, health, food and beverage, agricultural or environmental testing realms.\nDon't be afraid to choose a cannabis laboratory consultant to help you with the vendor selection process. But be sure to verify they offer true benefit.\nCaveats \nFirst, note that this cannabis testing LIMSpec is still an evolving entity. Standards change. Regulations change. Procedures change too with such changes. That means that as those foundational characteristics shift, this set of requirements will have to also evolve. As such, do your homework and don't take everything you see here as fixed law. If you're responsible for investigating and\/or purchasing a laboratory informatics system, be sure you have at least some familiarity with the cannabis testing industry, and by extension the standards and federal, state, and local regulations that affect it. \nSecond, as the legal status of cannabis in the U.S. changes, and state- and federal-based requirements evolve, laboratory informatics software tailored to cannabis laboratories will also have to evolve. This document will also need to reflect such changes. As such, this LIMSpec for Cannabis Testing is also evolving, and as industry experts and researchers are able to provide additional feedback on this document, it will surely grow with more relevant sources and requirements. In other words, don't consider this specification firmly complete. While efforts will be made to update it based on new regulations and standards, you may have to add more items based on your own industry knowledge and insights. We welcome input.\n\nLIMSpec in Microsoft Word format \nMicrosoft Excel is often used as a tool to document requirements specifications. However, one downside to Microsoft Excel is its inability to handle multiple hyperlinks in the same cell. If you've looked over the LIMSpec for Cannabis Testing, you've likely noticed there are multiple hyperlinks to regulations, specifications, and guidance documents in the first column of the tables. Translating these wiki-based documents to Excel makes for a challenge when trying to maintain those hyperlinks. As they add value to not only your laboratory's requirements research but also to vendors' understanding of the sources for your requirements, it was decided the hyperlinks should be maintained in any portable version. As such, a Microsoft Word version was created.\nYou can download a copy of the Microsoft Word version of LIMSpec for Cannabis Testing from CannaQAWiki by going to File:LIMSpec for Cannabis Testing v1.0.docx, right-clicking the URL under the white box, and selecting \"Save link as...\" (Alternatively, you can just click the link, open the file, and then save it.) A compromise was made between keeping the hyperlinks in the first column readable and leaving enough room in the third column for a vendor to provide a response. This response space admittedly may be a limiting factor for vendors wanting to include screenshots. If this situation arises, you may encourage the vendor to select the entire first column and delete it, then widening the response column.\nNote that this downloadable version of LIMSpec for Cannabis Testing is released under the same licensing terms as this guide. Please see the first paragraph of the download for more details.\n\nReferences \n\n\n\u2191 Pearce, O. (21 June 2016). \"Software Vendor Selection: How to Define Your Requirements\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements . Retrieved 23 June 2023 .   \n \n\n\u2191 Pearce, O. (23 June 2016). \"Software Vendor Selection: Finding the Right Vendor\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor . Retrieved 23 June 2023 .   \n \n\n\u2191 Pearce, O. (28 June 2016). \"Software Vendor Selection: The Pitfalls and Successes of Vendor Demos\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations . Retrieved 23 June 2023 .   \n \n\n\u2191 Pearce, O. (5 July 2016). \"Software Vendor Selection: Requesting Proposals & Quotes\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes . Retrieved 23 June 2023 .   \n \n\n\u2191 Persaud, D. (4 February 2016). \"Business Requirements Gathering for Enterprise Software Selection\". SelectHub Blog. Abuyo, Inc. https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/ . Retrieved 23 June 2023 .   \n \n\n\u2191 Lichtenberger, A. (23 July 2012). \"Six Steps for a Successful Vendor Selection\". ITIL.org. https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/ . Retrieved 23 June 2023 .   \n \n\n\u2191 Poon, L. (29 May 2015). \"Insider\u2019s Guide to LIMS Selection\". Genologics Blog. GenoLogics Life Sciences Software Inc. https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/ . Retrieved 20 September 2019 .   \n \n\n\u2191 \"How to Select an ELN for Biology R&D\". Benchling, Inc. https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf . Retrieved 23 June 2023 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Putting_LIMSpec_for_Cannabis_Testing_to_use\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Putting_LIMSpec_for_Cannabis_Testing_to_use<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 23 June 2023, at 19:00.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","db94e5424bc12b5bfc776047de49fec8_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Putting_LIMSpec_for_Cannabis_Testing_to_use rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Putting_LIMSpec_for_Cannabis_Testing_to_use skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Putting LIMSpec for Cannabis Testing to use<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n\n<h2><span class=\"mw-headline\" id=\"Putting_those_requirements_to_practical_use\">Putting those requirements to practical use<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=File:Requirements_Allocation_Sheet.jpg\" class=\"image wiki-link\" data-key=\"2dc7ee4b2402e2ba1b08eb51c3b75486\"><img alt=\"Requirements Allocation Sheet.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/c\/cf\/Requirements_Allocation_Sheet.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>Heavily based on <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMSpec_2019_R1\" class=\"extiw wiki-link\" title=\"limswiki:Book:LIMSpec 2019 R1\" data-key=\"be4a6879593cf6b89768cf1d794af185\">the existing LIMSpec<\/a> on LIMSwiki, this LIMSpec for Cannabis Testing covers <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"ac59b0790517a6fa5b6ba2b5c97cc6ac\">laboratory informatics<\/a> requirements for a <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Cannabis\" title=\"Cannabis\" class=\"wiki-link\" data-key=\"a70b76268930d795518ff1f98d7e500d\">cannabis<\/a> testing <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"ed14e6a67b4b14ad2c190c28455725f6\">laboratory<\/a>. The requirements are organized into five broad categories, which are heavily influenced by the functional requirements checklist and Figure 3 of ASTM E1578-18 <i>Standard Guide for Laboratory Informatics<\/i>. However, the requirements listed prior are all based on not just the ASTM E1578 standard but also a wide variety of other standards, regulations, guidance documents, and standardized procedures (here on out referred to as \"sources\"). That ultimately means a foundational reasoning is provided for almost every requirement, not necessarily a \"just because I want it\" reasoning. However, as described in <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing\" title=\"RefWork:LIMSpec for Cannabis Testing\/LIMS functionality requirements specific to cannabis testing\" class=\"wiki-link\" data-key=\"2e1c22fdf6eeb913ed7216dd143f9672\">Chapter 1<\/a>, the cannabis testing laboratory has a few specific requirements. As it turns out, many of those requirements\u2014e.g., third-party system integration\u2014are already baked into the original LIMSpec. Yet a few are not, and those requirements\u2014typically not supported by an existing standard or regulation\u2014have been added. In total, all these requirements provide an excellent starting point for building your own software requirements specification or for researching the best laboratory informatics solution for your cannabis testing laboratory. After all, not all informatics systems are equal, and that includes the various offerings of cannabis testing <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"300b107ea507dc9077934f573fc2f6d6\">laboratory information management system<\/a> (LIMS) vendors.\n<\/p><h3><span class=\"mw-headline\" id=\"Software_developer_considerations\">Software developer considerations<\/span><\/h3>\n<p>What does that mean for you? How can you best use this document? If you're a software developer for the cannabis testing industry, many of the sources referenced in these requirements should already be familiar to you. However, some of them may not be, and you'll probably want to at least familiarize yourself with them. Definitely review the requirements items listed throughout the entire document and make sure they are part of your own software requirements specification. In a few rare cases, a requirement may not make sense for your offering, and that's likely OK, as long as the requirement isn't regulatory-driven. How your business chooses to implement the resulting software requirements is also up to your business. However, keep software development standards and internal quality control in mind.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Buyer_considerations\">Buyer considerations<\/span><\/h3>\n<p>If you're a potential buyer of a cannabis testing informatics solution, this <i>LIMSpec for Cannabis Testing<\/i> is also useful to you. Perhaps you know a bit about your laboratory's workflow and a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed. Reviewing the five broad categories of requirements may be necessary to help further inform you regarding what's vital in regards to what a laboratory informatics solution should be capable of. Additionally, you can then use these requirements as a base for your laboratory's own requirements list. \n<\/p><p>After reviewing all the various requirements, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by this specification. However, do read the wording carefully, and especially be familiarized with Chapter 1 and its take on requirements specific to cannabis testing; it will map those industry-specific requirements to existing LIMSpec items. As you review the various requirement options available to you and narrow down your own needs, your list of requirements can be used as both a personal checklist and as a requirements list you hand over to the vendor you query.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Software_vendor_selection\">Software vendor selection<\/span><\/h4>\n<p>That said, the requirements you hand off to the vendor should be discussed a bit more. Software vendor selection can at times be a tedious yet necessary process, one which requires careful planning and best practices. This topic has been written about by both software developers and end users alike, and their experiences should play a role in how you select a vendor. What follows is bullet-pointed advice as offered by some of those developers and end users.<sup id=\"rdp-ebb-cite_ref-PearceSoftware16_1-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PearceSoftware16-2_2-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-2-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PearceSoftware16-3_3-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-3-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PearceSoftware16-4_4-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-4-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PersaudBusiness16_5-0\" class=\"reference\"><a href=\"#cite_note-PersaudBusiness16-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LichtenbergerSix12_6-0\" class=\"reference\"><a href=\"#cite_note-LichtenbergerSix12-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PoonInsider15_7-0\" class=\"reference\"><a href=\"#cite_note-PoonInsider15-7\">[7]<\/a><\/sup><sup class=\"noprint Inline-Template\"><span title=\"\" style=\"white-space: nowrap;\">[<i><a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Wikipedia:Link_rot\" data-key=\"7a2d9e87fd2845d41c68554d3d20a259\">dead link<\/a><\/i>]<\/span><\/sup><sup id=\"rdp-ebb-cite_ref-BenchlingHowTo_8-0\" class=\"reference\"><a href=\"#cite_note-BenchlingHowTo-8\">[8]<\/a><\/sup>\n<\/p>\n<ul><li>Have a clear business case and build your business needs into your laboratory's requirements.<\/li>\n<li>Be mindful of how detailed you get with your own business-based requirements and what you initially hand off to a vendor. If you're too specific with too many requirements, you may have trouble finding a vendor that matches up. Start with the essentials that involve your laboratory's processes, regulations, integrations, reporting, service needs, etc. As this cannabis testing LIMSpec is foundation-based, you have a good starting point in that regard. You can always get more detailed with requirements as you narrow down vendors.<\/li>\n<li>As discussed briefly in the introduction, you'll need to prioritize your needs somewhere between \"critical\" and \"nice to have.\" These requirements are largely critical for most purposes and can be marked as such. The requirements you add will have to be prioritized more carefully.<\/li>\n<li>You'll also want to perform some informal third-party information gathering about the vendors. Are reviews of the vendors trustworthy? Have peers had any interactions and success with the vendor? Does the vendor have the ability to scale to meet your needs?<\/li>\n<li>Schedule demonstrations of programs that seem like strong initial candidates. Make sure there is a question and answer session afterwards, and perform a post-demo evaluation.<\/li>\n<li>A formal request for proposal (RFP) may or may not be necessary, depending on the level of information you acquire prior. However, formally requesting pricing and clarification of maintenance and additional service costs is useful. Just don't let price be the only thing that guides you.<\/li>\n<li>Consider some of the intangibles. Does the vendor genuinely seem interested in your business and its needs? Do they communicate well and promptly? Do they seem flexible and able to accommodate a few special case requirements?<\/li>\n<li>Be sure to consider future needs as you anticipate potential laboratory expansion, particularly into other nutraceutical, health, food and beverage, agricultural or environmental testing realms.<\/li>\n<li>Don't be afraid to choose a cannabis laboratory consultant to help you with the vendor selection process. But be sure to verify they offer true benefit.<\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"Caveats\">Caveats<\/span><\/h2>\n<p>First, note that this cannabis testing LIMSpec is still an evolving entity. Standards change. Regulations change. Procedures change too with such changes. That means that as those foundational characteristics shift, this set of requirements will have to also evolve. As such, do your homework and don't take everything you see here as fixed law. If you're responsible for investigating and\/or purchasing a laboratory informatics system, be sure you have at least some familiarity with the cannabis testing industry, and by extension the standards and federal, state, and local regulations that affect it. \n<\/p><p>Second, as the legal status of cannabis in the U.S. changes, and state- and federal-based requirements evolve, laboratory informatics software tailored to cannabis laboratories will also have to evolve. This document will also need to reflect such changes. As such, this <i>LIMSpec for Cannabis Testing<\/i> is also evolving, and as industry experts and researchers are able to provide additional feedback on this document, it will surely grow with more relevant sources and requirements. In other words, don't consider this specification firmly complete. While efforts will be made to update it based on new regulations and standards, you may have to add more items based on your own industry knowledge and insights. We welcome input.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"LIMSpec_in_Microsoft_Word_format\">LIMSpec in Microsoft Word format<\/span><\/h2>\n<p>Microsoft Excel is often used as a tool to document requirements specifications. However, one downside to Microsoft Excel is its inability to handle multiple hyperlinks in the same cell. If you've looked over the <i>LIMSpec for Cannabis Testing<\/i>, you've likely noticed there are multiple hyperlinks to regulations, specifications, and guidance documents in the first column of the tables. Translating these wiki-based documents to Excel makes for a challenge when trying to maintain those hyperlinks. As they add value to not only your laboratory's requirements research but also to vendors' understanding of the sources for your requirements, it was decided the hyperlinks should be maintained in any portable version. As such, a Microsoft Word version was created.\n<\/p><p>You can download a copy of the Microsoft Word version of <i>LIMSpec for Cannabis Testing<\/i> from CannaQAWiki by going to <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=File:LIMSpec_for_Cannabis_Testing_v1.0.docx\" title=\"File:LIMSpec for Cannabis Testing v1.0.docx\" class=\"wiki-link\" data-key=\"b3e46f5ddc3b195f75735c50093fa7ed\">File:LIMSpec for Cannabis Testing v1.0.docx<\/a>, right-clicking the URL under the white box, and selecting \"Save link as...\" (Alternatively, you can just click the link, open the file, and then save it.) A compromise was made between keeping the hyperlinks in the first column readable and leaving enough room in the third column for a vendor to provide a response. This response space admittedly may be a limiting factor for vendors wanting to include screenshots. If this situation arises, you may encourage the vendor to select the entire first column and delete it, then widening the response column.\n<\/p><p>Note that this downloadable version of <i>LIMSpec for Cannabis Testing<\/i> is released under the same licensing terms as this guide. Please see the first paragraph of the download for more details.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-PearceSoftware16-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (21 June 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements\" target=\"_blank\">\"Software Vendor Selection: How to Define Your Requirements\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+How+to+Define+Your+Requirements&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=21+June+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-defining-your-requirements&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Putting_LIMSpec_for_Cannabis_Testing_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PearceSoftware16-2-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16-2_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (23 June 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor\" target=\"_blank\">\"Software Vendor Selection: Finding the Right Vendor\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+Finding+the+Right+Vendor&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=23+June+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-finding-the-right-vendor&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Putting_LIMSpec_for_Cannabis_Testing_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PearceSoftware16-3-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16-3_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (28 June 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations\" target=\"_blank\">\"Software Vendor Selection: The Pitfalls and Successes of Vendor Demos\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+The+Pitfalls+and+Successes+of+Vendor+Demos&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=28+June+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-conducting-demonstrations&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Putting_LIMSpec_for_Cannabis_Testing_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PearceSoftware16-4-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16-4_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (5 July 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes\" target=\"_blank\">\"Software Vendor Selection: Requesting Proposals & Quotes\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+Requesting+Proposals+%26+Quotes&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=5+July+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-requesting-proposals-quotes&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Putting_LIMSpec_for_Cannabis_Testing_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PersaudBusiness16-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PersaudBusiness16_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Persaud, D. (4 February 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/\" target=\"_blank\">\"Business Requirements Gathering for Enterprise Software Selection\"<\/a>. <i>SelectHub Blog<\/i>. Abuyo, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/\" target=\"_blank\">https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Business+Requirements+Gathering+for+Enterprise+Software+Selection&rft.atitle=SelectHub+Blog&rft.aulast=Persaud%2C+D.&rft.au=Persaud%2C+D.&rft.date=4+February+2016&rft.pub=Abuyo%2C+Inc&rft_id=https%3A%2F%2Fwww.selecthub.com%2Fmiscellaneous%2Ftechnology-selection%2Fbusiness-requirements-gathering-enterprise-software-selection%2F&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Putting_LIMSpec_for_Cannabis_Testing_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LichtenbergerSix12-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LichtenbergerSix12_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Lichtenberger, A. (23 July 2012). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/\" target=\"_blank\">\"Six Steps for a Successful Vendor Selection\"<\/a>. <i>ITIL.org<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/\" target=\"_blank\">https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Six+Steps+for+a+Successful+Vendor+Selection&rft.atitle=ITIL.org&rft.aulast=Lichtenberger%2C+A.&rft.au=Lichtenberger%2C+A.&rft.date=23+July+2012&rft_id=https%3A%2F%2Fblog.itil.org%2F2012%2F07%2Fsix-steps-for-a-successful-vendor-selection%2F&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Putting_LIMSpec_for_Cannabis_Testing_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PoonInsider15-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PoonInsider15_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Poon, L. (29 May 2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/\" target=\"_blank\">\"Insider\u2019s Guide to LIMS Selection\"<\/a>. <i>Genologics Blog<\/i>. GenoLogics Life Sciences Software Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/\" target=\"_blank\">https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 20 September 2019<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Insider%E2%80%99s+Guide+to+LIMS+Selection&rft.atitle=Genologics+Blog&rft.aulast=Poon%2C+L.&rft.au=Poon%2C+L.&rft.date=29+May+2015&rft.pub=GenoLogics+Life+Sciences+Software+Inc&rft_id=https%3A%2F%2Fwww.genologics.com%2Fblog%2Finsiders-guide-to-lims-selection%2F&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Putting_LIMSpec_for_Cannabis_Testing_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BenchlingHowTo-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BenchlingHowTo_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf\" target=\"_blank\">\"How to Select an ELN for Biology R&D\"<\/a>. Benchling, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf\" target=\"_blank\">https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+to+Select+an+ELN+for+Biology+R%26D&rft.atitle=&rft.pub=Benchling%2C+Inc&rft_id=https%3A%2F%2Fbenchling.com%2Fstatic%2Fdocs%2Fresources%2Feln-for-biology-rnd.pdf&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Putting_LIMSpec_for_Cannabis_Testing_to_use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230623190009\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.677 seconds\nReal time usage: 1.251 seconds\nPreprocessor visited node count: 5847\/1000000\nPost\u2010expand include size: 39181\/2097152 bytes\nTemplate argument size: 15717\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 12549\/5000000 bytes\nLua time usage: 0.050\/7 seconds\nLua virtual size: 5058560\/52428800 bytes\nLua estimated memory usage: 0 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 341.121 1 -total\n 56.50% 192.732 1 Template:Dead_link\n 55.07% 187.846 1 Template:Fix\n 50.07% 170.810 1 Template:Category_handler\n 43.14% 147.167 1 Template:Reflist\n 36.04% 122.952 8 Template:Cite_web\n 31.65% 107.961 8 Template:Citation\/core\n 7.17% 24.463 7 Template:Date\n 3.11% 10.626 1 Template:Cat_handler\n 2.84% 9.702 15 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5503-0!canonical and timestamp 20230623190008 and revision id 18376. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Putting_LIMSpec_for_Cannabis_Testing_to_use\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Putting_LIMSpec_for_Cannabis_Testing_to_use<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","db94e5424bc12b5bfc776047de49fec8_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/c\/cf\/Requirements_Allocation_Sheet.jpg"],"db94e5424bc12b5bfc776047de49fec8_timestamp":1687546824,"dc1cdf3e375b6de9f777812312d2e578_type":"article","dc1cdf3e375b6de9f777812312d2e578_title":"27. Information privacy","dc1cdf3e375b6de9f777812312d2e578_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#27._Information_privacy","dc1cdf3e375b6de9f777812312d2e578_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Security and integrity of systems and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.\n\n22. Data integrity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-17-1\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 9.1\n\n\n22.1 System functionality should support ALCOA principles.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa ASTM E1578-18 E-17-2\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\n\n\n22.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa 42 CFR Part 93.305\r\n\n\u25aa 42 CFR Part 93.310\r\n\n\u25aa ASTM E1578-18 E-17-3\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.4.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.9\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.9\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n22.3 The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.30\r\n\n\u25aa 7 CFR Part 331.17 (c)\r\n\n\u25aa 9 CFR Part 2.35\r\n\n\u25aa 9 CFR Part 121.17 (c)\r\n\n\u25aa 10 CFR Part 20.2103\u201310\r\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 10 CFR Part 30.51\u20132\r\n\n\u25aa 21 CFR Part 1.1154 (a)\r\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.195\r\n\n\u25aa 21 CFR Part 106.100 (n)\r\n\n\u25aa 21 CFR Part 112.164\r\n\n\u25aa 21 CFR Part 114.100 (e)\r\n\n\u25aa 21 CFR Part 117.315\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.9\r\n\n\u25aa 21 CFR Part 129.80 (h)\r\n\n\u25aa 21 CFR Part 211.180\r\n\n\u25aa 21 CFR Part 212.110 (c)\r\n\n\u25aa 21 CFR Part 225.42 (b-8)\r\n\n\u25aa 21 CFR Part 225.58 (c\u2013d)\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 225.202\r\n\n\u25aa 21 CFR Part 226.42 (a)\r\n\n\u25aa 21 CFR Part 226.58 (f)\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 226.115\r\n\n\u25aa 21 CFR Part 312.57\r\n\n\u25aa 21 CFR Part 312.62\r\n\n\u25aa 21 CFR Part 507.208\r\n\n\u25aa 21 CFR Part 606.160 (d)\r\n\n\u25aa 21 CFR Part 812.140 (d)\r\n\n\u25aa 21 CFR Part 820.180 (b)\r\n\n\u25aa 29 CFR Part 1910.120 (f)(8)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 40 CFR Part 141.722\r\n\n\u25aa 40 CFR Part 262.11 (f)\r\n\n\u25aa 40 CFR Part 262.40\r\n\n\u25aa 40 CFR Part 262.213\r\n\n\u25aa 40 CFR Part 704 Subpart A\r\n\n\u25aa 40 CFR Part 717.15 (d)\r\n\n\u25aa 42 CFR Part 73.17 (c)\r\n\n\u25aa 42 CFR Part 93.313 (h)\r\n\n\u25aa 42 CFR Part 93.317\r\n\n\u25aa 42 CFR Part 493.1105\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa 45 CFR Part 164.105\r\n\n\u25aa 45 CFR Part 164.316\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa A2LA C223 5.9\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.2.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.3.2\r\n\n\u25aa ABFT Accreditation Manual Sec. E-33\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.6\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories E2.1\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.5.1\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7\r\n\n\u25aa ASTM E1578-18 E-17-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.2\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy 5.4.6\u20137\r\n\n\u25aa CJIS Security Policy 5.5.2.1\r\n\n\u25aa CLSI QMS22 2.8.3\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.4\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa E.U. Annex 11-7.1\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 15\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.18\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.17\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3\r\n\n\u25aa ICH GCP 4.9.5\r\n\n\u25aa IFS Food 7, Part 2, 2.1.2.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 2.1.2.2\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, AU-11 and AU-11(1)\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa OSHA 1910.1020(d)(1)(i\u2013ii)\r\n\n\u25aa OSHA 1910.1450(j)(2)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c\r\n\n\u25aa USDA Sampling Procedures for PDP 6.5\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.8\u20139\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1\n\n\n22.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-17-6\r\n\n\u25aa CJIS Security Policy 5.4.4\r\n\n\u25aa NIST 800-53, Rev. 5, AU-8\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n22.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-17-7\r\n\n\u25aa CJIS Security Policy 5.6.1\n\n\n22.6 The system shall require each and every user to be assigned a unique user ID.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-17-8\r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa CJIS Security Policy 5.4.5\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 4, AU-9\n\n\n22.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.4.2\r\n\u25aa NIST 800-53, Rev. 4, AU-5\r\n\u25aa NIST 800-53, Rev. 4, SI-4\n\n22.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\r\n \r\n\r\n \r\n\n\n\n\n23. Configuration management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 S-1-1\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n23.1 The system shall provide tools to enter and manage user-configurable lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-2\n\n23.2 The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and\/or state and local regulations, including for specific substrate\/matrix types.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 162.1002\r\n\u25aa USDA Sampling Procedures for PDP 6.3.2\n\n23.3 The system shall allow system nomenclature to be configured to use specific data code sets or mandated terminology to support the regulatory requirements of the cannabis testing industry.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-3\n\n23.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-4\n\n23.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.100 (b)\r\n\u25aa 21 CFR Part 211.160 (a)\n\n23.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 40 CFR Part 3.10\r\n\n\u25aa 40 CFR Part 3.2000\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\n\u25aa ASTM E1578-18 S-1-5\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-6\n\n23.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-7\n\n23.9 The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-8\n\n23.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of the cannabis testing laboratory workflow.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-1-9\n\n\n23.11 The system should allow authorized personnel to perform revision control of lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-10\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n23.12 The system should provide a means for importing lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa AIHA-LAP Policies 2018 2A.7.8.4\r\n\n\u25aa ASTM E1578-18 S-1-11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.6\r\n\n\u25aa USDA Data and Instrumentation for PDP 9.1\n\n\n23.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-12\n\n23.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-13\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\n\n\n23.15 The system should provide a clear alert or notification upon entry of out-of-specification results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-14\n\n23.16 The system shall allow authorized personnel to update static and dynamic data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-15\n\n23.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-17\r\n\n\u25aa CJIS Security Policy 5.7.1\r\n\n\u25aa NIST 800-53, Rev. 4, AC-6(1)\r\n\n\u25aa NIST 800-53, Rev. 4, CM-7\n\n\n23.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-18\r\n\u25aa CAP Laboratory Accreditation Manual\n\n23.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-19\n\n23.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa ASTM E1578-18 S-1-20\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 4, CM-5(1)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.21 The system should support rules governing electronic records and electronic signatures in regulated environments like the cannabis testing industry.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 10 CFR Part 20.2110\r\n\n\u25aa 10 CFR Part 30.51 (c-1\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa A2LA C211 4.13.1.4\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.4.1\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1492-11 4.2.4\r\n\n\u25aa ASTM E1578-18 S-1-16\r\n\n\u25aa ASTM E1578-18 S-1-21\r\n\n\u25aa CJIS Security Policy 5.5.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14\r\n\n\u25aa ICH GCP 2.10\r\n\n\u25aa ISO\/IEC 17025:2017 4.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5 and CM-5(1)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\n\n\n23.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa CJIS Security Policy 5.5.2.2\u20133\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(11)\n\n\n23.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-22\r\n\u25aa NIST 800-53, Rev. 4, IA-2(10)\n\n23.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CJIS Security Policy 5.6.1\r\n\n\u25aa CLSI QMS22 2.4.2.2\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.4\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (a)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 4, IA-4 and IA-5\n\n\n23.26 The system shall prevent the same combination of identification components from being used across more than one account.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (b)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-5 and IA-5(1)\n\n\n23.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa CJIS Security Policy 5.6.3.1\r\n\n\u25aa NIST 800-53, Rev. 4, AC-2(3)\r\n\n\u25aa NIST 800-53, Rev. 4, IA-4 and IA-5(1)\r\n\n\u25aa NIST 800-53, Rev. 4, PS-4\n\n\n23.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.2.2\r\n\u25aa NIST 800-53, Rev. 4, AC-10\n\n23.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.4\r\n\u25aa NIST 800-53, Rev. 4, AC-8\n\n23.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (d)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.4.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\n\n\n23.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (d)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CJIS Security Policy 5.5.3\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 4, AC-7\n\n\n23.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\u25aa ASTM E1578-18 S-3-1\n\n23.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 21 CFR Part 211.188 (b-11)\r\n\n\u25aa 21 CFR Part 211.194 (a-7 and a-8)\r\n\n\u25aa 21 CFR Part 212.50 (c-10)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa ASTM E1578-18 S-3-1\r\n\n\u25aa CJIS Security Policy 5.6.3.2\r\n\n\u25aa NIST 800-53, Rev. 5, IA-5\n\n\n23.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 S-1-25\r\n\n\u25aa CJIS Security Policy 5.5.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa NIST 800-53, Rev. 5, AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\n\n\n23.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa ASTM E1578-18 S-1-24\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10 and AU-10(3)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa ASTM E1578-18 S-1-24\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10 and AU-10(3)\n\n\n23.37 The system shall prevent the reuse or reassignment of a user's electronic signature.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.50\r\n\u25aa E.U. Annex 11-14\n\n23.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-26\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI QMS22 2.8.5.3\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.39 The system should provide a means to migrate static data into the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, IA-5(1)\r\n\u25aa CLSI QMS22 2.4.2\n\n23.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 4, IA-6\n\n23.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\r\n \r\n\r\n \r\n\n\n\n\n24. System validation and commission \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 S-2-1\r\n\n\u25aa CJIS Security Policy Appendix G.8\r\n\n\u25aa NIST 800-53, Rev. 5, SA-4(3)\n\n\n24.1 The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-2-2\r\n\u25aa NIST 800-53, Rev. 5, SA-4(2)\n\n24.2 The vendor should be willing to provide access to source code through a suitable escrow.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-2-3\n\n24.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa ASTM E1578-18 S-2-4\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.5\r\n\n\u25aa NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5\n\n\n24.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (a)\r\n\n\u25aa 21 CFR Part 820.70 (i)\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa E.U. Annex 11-11\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 10.2\n\n\n24.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-2-2\r\n\n\u25aa CLSI QMS22 2.5\r\n\n\u25aa E.U. Annex 11-4\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 10.3\u20137\n\n\n24.6 The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\r\n \r\n\r\n \r\n\n\n\n\n25. System administration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d-5)\r\n\n\u25aa ASTM E1578-18 S-3-1\r\n\n\u25aa CJIS Security Policy 5.5.5\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-11 and AC-12\n\n\n25.1 The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-2\n\n25.2 The system should provide a means for modifying personnel data in a batch.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-3\n\n25.3 The system should support the storage and export of data in standard and industry-specific data formats, e.g., CSV, especially for regulatory reporting purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-3-7\r\n\n\u25aa CJIS Security Policy 5.5.1\r\n\n\u25aa CJIS Security Policy 5.5.2.4\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa ISO 15189:2012 5.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2 and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\r\n\n\u25aa NIST 800-53, Rev. 5, PS-4 and PS-5\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5.1.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1\n\n\n25.4 The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-8\n\n25.5 The vendor should provide maintenance agreements and support services for its applications and services.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-3-9\r\n\n\u25aa E.U. Annex 11-3.3\r\n\n\u25aa NIST 800-53, Rev. 5, SA-16\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\n\n\n25.6 The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.4.3\r\n\n\u25aa ABFT Accreditation Manual Sec. D-5\u2013D-8\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1492-11 4.2.4\r\n\n\u25aa CJIS Security Policy 5.5.2\r\n\n\u25aa CJIS Security Policy 5.8.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.6\r\n\n\u25aa E.U. Annex 11-7.1\r\n\n\u25aa E.U. Annex 11-12\r\n\n\u25aa ISO 15189:2012 5.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa NIST 800-53, Rev. 5, MA-5\r\n\n\u25aa NIST 800-53, Rev. 5, MP-2\r\n\n\u25aa NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\n\n\n25.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.1\n\n25.8 The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1578-18 S-3-10\n\n\n25.9 The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-3-11\r\n\n\u25aa CJIS Security Policy 5.10.4.1\r\n\n\u25aa CLSI QMS22 2.1.4\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.13\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2(5)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n25.10 The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-12\n\n25.11 The system shall provide a means for migrating data to a new release upon system upgrade.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 1.1154 (b)\r\n\u25aa ASTM E1578-18 S-3-13\n\n25.12 The system should be expedient with the retrieval of stored items.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (b)\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa E.U. Annex 11-5\r\n\n\u25aa E.U. Annex 11-8.1\n\n\n25.13 The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-14\n\n25.14 The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-3-15\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-3(2)\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2\n\n\n25.15 The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\r\n \r\n\r\n \r\n\n\n\n\n26. Cybersecurity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d-9)\r\n\n\u25aa ASTM E1578-18 S-4-1\r\n\n\u25aa CJIS Security Policy 5.6.4\r\n\n\u25aa CJIS Security Policy 5.8.2.1\r\n\n\u25aa CJIS Security Policy 5.10.1.2\r\n\n\u25aa CJIS Security Policy Appendix G.6\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa NIST 800-53, Rev. 5, AC-17(2)\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4(6)\r\n\n\u25aa NIST 800-53, Rev. 5, SC-8 and SC-8(1)\n\n\n26.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.6\r\n\n\u25aa ASTM E1578-18 S-4-2\r\n\n\u25aa CJIS Security Policy 5.5.2.4\r\n\n\u25aa CJIS Security Policy 5.10.1.2\r\n\n\u25aa CJIS Security Policy Appendix G.6\r\n\n\u25aa NIST 800-53, Rev. 5, CP-9(8)\r\n\n\u25aa NIST 800-53, Rev. 5, SC-13 and SC-28(1)\n\n\n26.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa CJIS Security Policy 5.6.2.2.1\r\n\n\u25aa CLSI QMS22 2.4.2.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\n\n\n26.3 The system should be able to support multifactor authentication.\n\n\n\u25aa 45 CFR Part 170.202\r\n\u25aa 45 CFR Part 170.315 (h)\n\n26.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information (e.g., medical marijuana user data).\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, IA-7\n\n26.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, SC-15\n\n26.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\r\n \r\n\r\n \r\n\n\n\n\n27. Information privacy \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 45 CFR Part 164 Subpart E\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G17.2\r\n\n\u25aa ASTM E1578-18 S-5-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NIST 800-53, Rev. 5, PT-2 and PT-2(2)\n\n\n27.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions (e.g., when handling medical marijuana user data).\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2106 (d)\r\n\n\u25aa 45 CFR Part 164.105\r\n\n\u25aa 45 CFR Part 164 Subpart C\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 S-5-2\r\n\n\u25aa ICH GCP 2.11\r\n\n\u25aa NIST 800-53, Rev. 5, PT-2 and PT-2(2)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.3\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\n\n\n27.2 The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.5\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NIST 800-53, Rev. 5, SI-19\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3\n\n\n27.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 164 Subpart E\r\n\u25aa NIST 800-53, Rev. 5, AC-6\r\n\u25aa NIST 800-53, Rev. 5, SI-19\n\n27.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\r\n \r\n\r\n \r\n\n\n\nNIST 800-53, Rev. 5, SI-19(7)\n\n36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n\n\nNIST 800-53, Rev. 5, PT-4 and PT-4(3)\n\n36.6 The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#27._Information_privacy\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#27._Information_privacy<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 21 January 2021, at 21:17.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","dc1cdf3e375b6de9f777812312d2e578_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Security_and_integrity_of_systems_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Security_and_integrity_of_systems_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Security and integrity of systems and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"22._Data_integrity\">22. Data integrity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.1<\/b> System functionality should support ALCOA principles.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.2<\/b> The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.305\" target=\"_blank\">42 CFR Part 93.305<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.310\" target=\"_blank\">42 CFR Part 93.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.3<\/b> The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.30\" target=\"_blank\">7 CFR Part 91.30<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.195\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (n)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.164<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.180\" target=\"_blank\">21 CFR Part 211.180<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 212.110 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42 (b-8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.115\" target=\"_blank\">21 CFR Part 226.115<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.208<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120 (f)(8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.722\" target=\"_blank\">40 CFR Part 141.722<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.11\" target=\"_blank\">40 CFR Part 262.11 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.40\" target=\"_blank\">40 CFR Part 262.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.213\" target=\"_blank\">40 CFR Part 262.213<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\/subpart-A\" target=\"_blank\">40 CFR Part 704 Subpart A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/717.15\" target=\"_blank\">40 CFR Part 717.15 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.313\" target=\"_blank\">42 CFR Part 93.313 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.317\" target=\"_blank\">42 CFR Part 93.317<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.316\" target=\"_blank\">45 CFR Part 164.316<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.4<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.18<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.1.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.1.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-11 and AU-11(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020(d)(1)(i\u2013ii)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(j)(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8\u20139<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.4<\/b> The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.5<\/b> The system shall accurately reflect the system date and time in its use of electronic record time stamps.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.6<\/b> The system shall require each and every user to be assigned a unique user ID.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.7<\/b> The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SI-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.8<\/b> The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Configuration_management\">23. Configuration management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.1<\/b> The system shall provide tools to enter and manage user-configurable lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.2<\/b> The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and\/or state and local regulations, including for specific substrate\/matrix types.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.1002\" target=\"_blank\">45 CFR Part 162.1002<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.3<\/b> The system shall allow system nomenclature to be configured to use specific data code sets or mandated terminology to support the regulatory requirements of the cannabis testing industry.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.4<\/b> The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.5<\/b> The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.6<\/b> The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.2000\" target=\"_blank\">40 CFR Part 3.2000<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.7<\/b> The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.8<\/b> The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.9<\/b> The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.10<\/b> The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of the cannabis testing laboratory workflow.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.11<\/b> The system should allow authorized personnel to perform revision control of lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-10<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.12<\/b> The system should provide a means for importing lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.13<\/b> The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.14<\/b> The system should allow calculated limits to be created and managed based on test results and relevant metadata.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.15<\/b> The system should provide a clear alert or notification upon entry of out-of-specification results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.16<\/b> The system shall allow authorized personnel to update static and dynamic data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.17<\/b> The system should allow workflow events and status changes to trigger one or more user-defined actions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.18<\/b> The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-18<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.19<\/b> The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-19<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.20<\/b> The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.21<\/b> The system should support rules governing electronic records and electronic signatures in regulated environments like the cannabis testing industry.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2110\" target=\"_blank\">10 CFR Part 20.2110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51 (c-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5 and CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.22<\/b> The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(11)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.23<\/b> The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-2(10)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.24<\/b> The system should support single sign-on such that a user can log in once and access all permitted functions and data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.25<\/b> The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-4 and IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.26<\/b> The system shall prevent the same combination of identification components from being used across more than one account.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5 and IA-5(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.27<\/b> The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-2(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-4 and IA-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, PS-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.28<\/b> The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.29<\/b> The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.30<\/b> The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.31<\/b> The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.32<\/b> The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.33<\/b> The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188 (b-11)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (a-7 and a-8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (c-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.34<\/b> The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.35<\/b> The system shall support the ability to initially assign new individual users to system groups, roles, or both.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.36<\/b> The system shall force a user's electronic signature to be unique and traceable to a specific user's account.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.37<\/b> The system shall prevent the reuse or reassignment of a user's electronic signature.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.50\" target=\"_blank\">21 CFR Part 11.50<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.38<\/b> When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.39<\/b> The system should provide a means to migrate static data into the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.40<\/b> The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.41<\/b> The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._System_validation_and_commission\">24. System validation and commission<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.1<\/b> The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.2<\/b> The vendor should be willing to provide access to source code through a suitable escrow.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.3<\/b> The system should be able to document a summary and evaluation of enterprise performance markers and processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.4<\/b> The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.5<\/b> The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.3\u20137<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.6<\/b> The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._System_administration\">25. System administration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-11 and AC-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.1<\/b> The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.2<\/b> The system should provide a means for modifying personnel data in a batch.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.3<\/b> The system should support the storage and export of data in standard and industry-specific data formats, e.g., CSV, especially for regulatory reporting purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2 and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4 and PS-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.4<\/b> The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.5<\/b> The vendor should provide maintenance agreements and support services for its applications and services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.6<\/b> The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-5\u2013D-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.7<\/b> The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.8<\/b> The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.9<\/b> The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2(5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.10<\/b> The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.11<\/b> The system shall provide a means for migrating data to a new release upon system upgrade.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.12<\/b> The system should be expedient with the retrieval of stored items.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.13<\/b> The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.14<\/b> The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-3(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.15<\/b> The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"26._Cybersecurity\">26. Cybersecurity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4(6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-8 and SC-8(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.1<\/b> The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9(8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13 and SC-28(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.2<\/b> The system should support database encryption and be capable of recording the encryption status of the data contained within.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.3<\/b> The system should be able to support multifactor authentication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.202\" target=\"_blank\">45 CFR Part 170.202<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (h)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.4<\/b> The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information (e.g., medical marijuana user data).<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.5<\/b> The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.6<\/b> The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"27._Information_privacy\">27. Information privacy<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-2 and PT-2(2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.1<\/b> The system shall comply with privacy protection compliance like that found in HIPAA provisions (e.g., when handling medical marijuana user data).<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2106\" target=\"_blank\">10 CFR Part 20.2106 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-C\" target=\"_blank\">45 CFR Part 164 Subpart C<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-2 and PT-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.2<\/b> The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.3<\/b> The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.4<\/b> The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.5<\/b> The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-4 and PT-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.6<\/b> The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184910\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.086 seconds\nReal time usage: 0.097 seconds\nPreprocessor visited node count: 886\/1000000\nPost\u2010expand include size: 92860\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 26.435 1 -total\n 20.88% 5.519 1 Template:LIMSpec_for_Cannabis_Testing\/Configuration_management\n 18.46% 4.879 1 Template:LIMSpec_for_Cannabis_Testing\/Data_integrity\n 17.07% 4.512 1 Template:LIMSpec_for_Cannabis_Testing\/System_validation_and_commission\n 16.62% 4.393 1 Template:LIMSpec_for_Cannabis_Testing\/System_administration\n 12.14% 3.210 1 Template:LIMSpec_for_Cannabis_Testing\/Information_privacy\n 11.77% 3.112 1 Template:LIMSpec_for_Cannabis_Testing\/Cybersecurity\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5485-0!canonical and timestamp 20230623184910 and revision id 16580. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#27._Information_privacy\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#27._Information_privacy<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","dc1cdf3e375b6de9f777812312d2e578_images":[],"dc1cdf3e375b6de9f777812312d2e578_timestamp":1687546824,"61d27181a0110b64e94d66635bc8243e_type":"article","61d27181a0110b64e94d66635bc8243e_title":"26. Cybersecurity","61d27181a0110b64e94d66635bc8243e_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#26._Cybersecurity","61d27181a0110b64e94d66635bc8243e_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Security and integrity of systems and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.\n\n22. Data integrity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-17-1\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 9.1\n\n\n22.1 System functionality should support ALCOA principles.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa ASTM E1578-18 E-17-2\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\n\n\n22.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa 42 CFR Part 93.305\r\n\n\u25aa 42 CFR Part 93.310\r\n\n\u25aa ASTM E1578-18 E-17-3\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.4.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.9\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.9\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n22.3 The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.30\r\n\n\u25aa 7 CFR Part 331.17 (c)\r\n\n\u25aa 9 CFR Part 2.35\r\n\n\u25aa 9 CFR Part 121.17 (c)\r\n\n\u25aa 10 CFR Part 20.2103\u201310\r\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 10 CFR Part 30.51\u20132\r\n\n\u25aa 21 CFR Part 1.1154 (a)\r\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.195\r\n\n\u25aa 21 CFR Part 106.100 (n)\r\n\n\u25aa 21 CFR Part 112.164\r\n\n\u25aa 21 CFR Part 114.100 (e)\r\n\n\u25aa 21 CFR Part 117.315\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.9\r\n\n\u25aa 21 CFR Part 129.80 (h)\r\n\n\u25aa 21 CFR Part 211.180\r\n\n\u25aa 21 CFR Part 212.110 (c)\r\n\n\u25aa 21 CFR Part 225.42 (b-8)\r\n\n\u25aa 21 CFR Part 225.58 (c\u2013d)\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 225.202\r\n\n\u25aa 21 CFR Part 226.42 (a)\r\n\n\u25aa 21 CFR Part 226.58 (f)\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 226.115\r\n\n\u25aa 21 CFR Part 312.57\r\n\n\u25aa 21 CFR Part 312.62\r\n\n\u25aa 21 CFR Part 507.208\r\n\n\u25aa 21 CFR Part 606.160 (d)\r\n\n\u25aa 21 CFR Part 812.140 (d)\r\n\n\u25aa 21 CFR Part 820.180 (b)\r\n\n\u25aa 29 CFR Part 1910.120 (f)(8)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 40 CFR Part 141.722\r\n\n\u25aa 40 CFR Part 262.11 (f)\r\n\n\u25aa 40 CFR Part 262.40\r\n\n\u25aa 40 CFR Part 262.213\r\n\n\u25aa 40 CFR Part 704 Subpart A\r\n\n\u25aa 40 CFR Part 717.15 (d)\r\n\n\u25aa 42 CFR Part 73.17 (c)\r\n\n\u25aa 42 CFR Part 93.313 (h)\r\n\n\u25aa 42 CFR Part 93.317\r\n\n\u25aa 42 CFR Part 493.1105\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa 45 CFR Part 164.105\r\n\n\u25aa 45 CFR Part 164.316\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa A2LA C223 5.9\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.2.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.3.2\r\n\n\u25aa ABFT Accreditation Manual Sec. E-33\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.6\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories E2.1\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.5.1\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7\r\n\n\u25aa ASTM E1578-18 E-17-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.2\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy 5.4.6\u20137\r\n\n\u25aa CJIS Security Policy 5.5.2.1\r\n\n\u25aa CLSI QMS22 2.8.3\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.4\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa E.U. Annex 11-7.1\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 15\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.18\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.17\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3\r\n\n\u25aa ICH GCP 4.9.5\r\n\n\u25aa IFS Food 7, Part 2, 2.1.2.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 2.1.2.2\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, AU-11 and AU-11(1)\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa OSHA 1910.1020(d)(1)(i\u2013ii)\r\n\n\u25aa OSHA 1910.1450(j)(2)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c\r\n\n\u25aa USDA Sampling Procedures for PDP 6.5\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.8\u20139\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1\n\n\n22.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-17-6\r\n\n\u25aa CJIS Security Policy 5.4.4\r\n\n\u25aa NIST 800-53, Rev. 5, AU-8\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n22.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-17-7\r\n\n\u25aa CJIS Security Policy 5.6.1\n\n\n22.6 The system shall require each and every user to be assigned a unique user ID.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-17-8\r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa CJIS Security Policy 5.4.5\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 4, AU-9\n\n\n22.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.4.2\r\n\u25aa NIST 800-53, Rev. 4, AU-5\r\n\u25aa NIST 800-53, Rev. 4, SI-4\n\n22.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\r\n \r\n\r\n \r\n\n\n\n\n23. Configuration management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 S-1-1\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n23.1 The system shall provide tools to enter and manage user-configurable lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-2\n\n23.2 The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and\/or state and local regulations, including for specific substrate\/matrix types.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 162.1002\r\n\u25aa USDA Sampling Procedures for PDP 6.3.2\n\n23.3 The system shall allow system nomenclature to be configured to use specific data code sets or mandated terminology to support the regulatory requirements of the cannabis testing industry.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-3\n\n23.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-4\n\n23.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.100 (b)\r\n\u25aa 21 CFR Part 211.160 (a)\n\n23.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 40 CFR Part 3.10\r\n\n\u25aa 40 CFR Part 3.2000\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\n\u25aa ASTM E1578-18 S-1-5\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-6\n\n23.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-7\n\n23.9 The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-8\n\n23.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of the cannabis testing laboratory workflow.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-1-9\n\n\n23.11 The system should allow authorized personnel to perform revision control of lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-10\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n23.12 The system should provide a means for importing lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa AIHA-LAP Policies 2018 2A.7.8.4\r\n\n\u25aa ASTM E1578-18 S-1-11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.6\r\n\n\u25aa USDA Data and Instrumentation for PDP 9.1\n\n\n23.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-12\n\n23.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-13\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\n\n\n23.15 The system should provide a clear alert or notification upon entry of out-of-specification results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-14\n\n23.16 The system shall allow authorized personnel to update static and dynamic data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-15\n\n23.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-17\r\n\n\u25aa CJIS Security Policy 5.7.1\r\n\n\u25aa NIST 800-53, Rev. 4, AC-6(1)\r\n\n\u25aa NIST 800-53, Rev. 4, CM-7\n\n\n23.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-18\r\n\u25aa CAP Laboratory Accreditation Manual\n\n23.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-19\n\n23.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa ASTM E1578-18 S-1-20\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 4, CM-5(1)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.21 The system should support rules governing electronic records and electronic signatures in regulated environments like the cannabis testing industry.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 10 CFR Part 20.2110\r\n\n\u25aa 10 CFR Part 30.51 (c-1\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa A2LA C211 4.13.1.4\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.4.1\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1492-11 4.2.4\r\n\n\u25aa ASTM E1578-18 S-1-16\r\n\n\u25aa ASTM E1578-18 S-1-21\r\n\n\u25aa CJIS Security Policy 5.5.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14\r\n\n\u25aa ICH GCP 2.10\r\n\n\u25aa ISO\/IEC 17025:2017 4.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5 and CM-5(1)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\n\n\n23.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa CJIS Security Policy 5.5.2.2\u20133\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(11)\n\n\n23.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-22\r\n\u25aa NIST 800-53, Rev. 4, IA-2(10)\n\n23.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CJIS Security Policy 5.6.1\r\n\n\u25aa CLSI QMS22 2.4.2.2\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.4\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (a)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 4, IA-4 and IA-5\n\n\n23.26 The system shall prevent the same combination of identification components from being used across more than one account.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (b)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-5 and IA-5(1)\n\n\n23.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa CJIS Security Policy 5.6.3.1\r\n\n\u25aa NIST 800-53, Rev. 4, AC-2(3)\r\n\n\u25aa NIST 800-53, Rev. 4, IA-4 and IA-5(1)\r\n\n\u25aa NIST 800-53, Rev. 4, PS-4\n\n\n23.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.2.2\r\n\u25aa NIST 800-53, Rev. 4, AC-10\n\n23.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.4\r\n\u25aa NIST 800-53, Rev. 4, AC-8\n\n23.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (d)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.4.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\n\n\n23.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (d)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CJIS Security Policy 5.5.3\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 4, AC-7\n\n\n23.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\u25aa ASTM E1578-18 S-3-1\n\n23.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 21 CFR Part 211.188 (b-11)\r\n\n\u25aa 21 CFR Part 211.194 (a-7 and a-8)\r\n\n\u25aa 21 CFR Part 212.50 (c-10)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa ASTM E1578-18 S-3-1\r\n\n\u25aa CJIS Security Policy 5.6.3.2\r\n\n\u25aa NIST 800-53, Rev. 5, IA-5\n\n\n23.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 S-1-25\r\n\n\u25aa CJIS Security Policy 5.5.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa NIST 800-53, Rev. 5, AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\n\n\n23.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa ASTM E1578-18 S-1-24\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10 and AU-10(3)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa ASTM E1578-18 S-1-24\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10 and AU-10(3)\n\n\n23.37 The system shall prevent the reuse or reassignment of a user's electronic signature.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.50\r\n\u25aa E.U. Annex 11-14\n\n23.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-26\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI QMS22 2.8.5.3\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.39 The system should provide a means to migrate static data into the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, IA-5(1)\r\n\u25aa CLSI QMS22 2.4.2\n\n23.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 4, IA-6\n\n23.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\r\n \r\n\r\n \r\n\n\n\n\n24. System validation and commission \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 S-2-1\r\n\n\u25aa CJIS Security Policy Appendix G.8\r\n\n\u25aa NIST 800-53, Rev. 5, SA-4(3)\n\n\n24.1 The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-2-2\r\n\u25aa NIST 800-53, Rev. 5, SA-4(2)\n\n24.2 The vendor should be willing to provide access to source code through a suitable escrow.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-2-3\n\n24.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa ASTM E1578-18 S-2-4\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.5\r\n\n\u25aa NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5\n\n\n24.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (a)\r\n\n\u25aa 21 CFR Part 820.70 (i)\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa E.U. Annex 11-11\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 10.2\n\n\n24.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-2-2\r\n\n\u25aa CLSI QMS22 2.5\r\n\n\u25aa E.U. Annex 11-4\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 10.3\u20137\n\n\n24.6 The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\r\n \r\n\r\n \r\n\n\n\n\n25. System administration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d-5)\r\n\n\u25aa ASTM E1578-18 S-3-1\r\n\n\u25aa CJIS Security Policy 5.5.5\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-11 and AC-12\n\n\n25.1 The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-2\n\n25.2 The system should provide a means for modifying personnel data in a batch.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-3\n\n25.3 The system should support the storage and export of data in standard and industry-specific data formats, e.g., CSV, especially for regulatory reporting purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-3-7\r\n\n\u25aa CJIS Security Policy 5.5.1\r\n\n\u25aa CJIS Security Policy 5.5.2.4\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa ISO 15189:2012 5.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2 and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\r\n\n\u25aa NIST 800-53, Rev. 5, PS-4 and PS-5\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5.1.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1\n\n\n25.4 The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-8\n\n25.5 The vendor should provide maintenance agreements and support services for its applications and services.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-3-9\r\n\n\u25aa E.U. Annex 11-3.3\r\n\n\u25aa NIST 800-53, Rev. 5, SA-16\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\n\n\n25.6 The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.4.3\r\n\n\u25aa ABFT Accreditation Manual Sec. D-5\u2013D-8\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1492-11 4.2.4\r\n\n\u25aa CJIS Security Policy 5.5.2\r\n\n\u25aa CJIS Security Policy 5.8.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.6\r\n\n\u25aa E.U. Annex 11-7.1\r\n\n\u25aa E.U. Annex 11-12\r\n\n\u25aa ISO 15189:2012 5.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa NIST 800-53, Rev. 5, MA-5\r\n\n\u25aa NIST 800-53, Rev. 5, MP-2\r\n\n\u25aa NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\n\n\n25.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.1\n\n25.8 The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1578-18 S-3-10\n\n\n25.9 The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-3-11\r\n\n\u25aa CJIS Security Policy 5.10.4.1\r\n\n\u25aa CLSI QMS22 2.1.4\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.13\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2(5)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n25.10 The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-12\n\n25.11 The system shall provide a means for migrating data to a new release upon system upgrade.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 1.1154 (b)\r\n\u25aa ASTM E1578-18 S-3-13\n\n25.12 The system should be expedient with the retrieval of stored items.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (b)\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa E.U. Annex 11-5\r\n\n\u25aa E.U. Annex 11-8.1\n\n\n25.13 The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-14\n\n25.14 The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-3-15\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-3(2)\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2\n\n\n25.15 The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\r\n \r\n\r\n \r\n\n\n\n\n26. Cybersecurity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d-9)\r\n\n\u25aa ASTM E1578-18 S-4-1\r\n\n\u25aa CJIS Security Policy 5.6.4\r\n\n\u25aa CJIS Security Policy 5.8.2.1\r\n\n\u25aa CJIS Security Policy 5.10.1.2\r\n\n\u25aa CJIS Security Policy Appendix G.6\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa NIST 800-53, Rev. 5, AC-17(2)\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4(6)\r\n\n\u25aa NIST 800-53, Rev. 5, SC-8 and SC-8(1)\n\n\n26.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.6\r\n\n\u25aa ASTM E1578-18 S-4-2\r\n\n\u25aa CJIS Security Policy 5.5.2.4\r\n\n\u25aa CJIS Security Policy 5.10.1.2\r\n\n\u25aa CJIS Security Policy Appendix G.6\r\n\n\u25aa NIST 800-53, Rev. 5, CP-9(8)\r\n\n\u25aa NIST 800-53, Rev. 5, SC-13 and SC-28(1)\n\n\n26.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa CJIS Security Policy 5.6.2.2.1\r\n\n\u25aa CLSI QMS22 2.4.2.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\n\n\n26.3 The system should be able to support multifactor authentication.\n\n\n\u25aa 45 CFR Part 170.202\r\n\u25aa 45 CFR Part 170.315 (h)\n\n26.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information (e.g., medical marijuana user data).\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, IA-7\n\n26.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, SC-15\n\n26.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\r\n \r\n\r\n \r\n\n\n\n\n27. Information privacy \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 45 CFR Part 164 Subpart E\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G17.2\r\n\n\u25aa ASTM E1578-18 S-5-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NIST 800-53, Rev. 5, PT-2 and PT-2(2)\n\n\n27.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions (e.g., when handling medical marijuana user data).\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2106 (d)\r\n\n\u25aa 45 CFR Part 164.105\r\n\n\u25aa 45 CFR Part 164 Subpart C\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 S-5-2\r\n\n\u25aa ICH GCP 2.11\r\n\n\u25aa NIST 800-53, Rev. 5, PT-2 and PT-2(2)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.3\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\n\n\n27.2 The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.5\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NIST 800-53, Rev. 5, SI-19\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3\n\n\n27.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 164 Subpart E\r\n\u25aa NIST 800-53, Rev. 5, AC-6\r\n\u25aa NIST 800-53, Rev. 5, SI-19\n\n27.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\r\n \r\n\r\n \r\n\n\n\nNIST 800-53, Rev. 5, SI-19(7)\n\n36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n\n\nNIST 800-53, Rev. 5, PT-4 and PT-4(3)\n\n36.6 The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#26._Cybersecurity\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#26._Cybersecurity<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 21 January 2021, at 21:17.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","61d27181a0110b64e94d66635bc8243e_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Security_and_integrity_of_systems_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Security_and_integrity_of_systems_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Security and integrity of systems and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"22._Data_integrity\">22. Data integrity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.1<\/b> System functionality should support ALCOA principles.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.2<\/b> The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.305\" target=\"_blank\">42 CFR Part 93.305<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.310\" target=\"_blank\">42 CFR Part 93.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.3<\/b> The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.30\" target=\"_blank\">7 CFR Part 91.30<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.195\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (n)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.164<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.180\" target=\"_blank\">21 CFR Part 211.180<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 212.110 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42 (b-8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.115\" target=\"_blank\">21 CFR Part 226.115<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.208<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120 (f)(8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.722\" target=\"_blank\">40 CFR Part 141.722<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.11\" target=\"_blank\">40 CFR Part 262.11 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.40\" target=\"_blank\">40 CFR Part 262.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.213\" target=\"_blank\">40 CFR Part 262.213<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\/subpart-A\" target=\"_blank\">40 CFR Part 704 Subpart A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/717.15\" target=\"_blank\">40 CFR Part 717.15 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.313\" target=\"_blank\">42 CFR Part 93.313 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.317\" target=\"_blank\">42 CFR Part 93.317<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.316\" target=\"_blank\">45 CFR Part 164.316<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.4<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.18<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.1.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.1.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-11 and AU-11(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020(d)(1)(i\u2013ii)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(j)(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8\u20139<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.4<\/b> The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.5<\/b> The system shall accurately reflect the system date and time in its use of electronic record time stamps.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.6<\/b> The system shall require each and every user to be assigned a unique user ID.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.7<\/b> The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SI-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.8<\/b> The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Configuration_management\">23. Configuration management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.1<\/b> The system shall provide tools to enter and manage user-configurable lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.2<\/b> The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and\/or state and local regulations, including for specific substrate\/matrix types.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.1002\" target=\"_blank\">45 CFR Part 162.1002<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.3<\/b> The system shall allow system nomenclature to be configured to use specific data code sets or mandated terminology to support the regulatory requirements of the cannabis testing industry.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.4<\/b> The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.5<\/b> The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.6<\/b> The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.2000\" target=\"_blank\">40 CFR Part 3.2000<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.7<\/b> The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.8<\/b> The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.9<\/b> The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.10<\/b> The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of the cannabis testing laboratory workflow.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.11<\/b> The system should allow authorized personnel to perform revision control of lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-10<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.12<\/b> The system should provide a means for importing lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.13<\/b> The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.14<\/b> The system should allow calculated limits to be created and managed based on test results and relevant metadata.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.15<\/b> The system should provide a clear alert or notification upon entry of out-of-specification results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.16<\/b> The system shall allow authorized personnel to update static and dynamic data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.17<\/b> The system should allow workflow events and status changes to trigger one or more user-defined actions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.18<\/b> The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-18<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.19<\/b> The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-19<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.20<\/b> The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.21<\/b> The system should support rules governing electronic records and electronic signatures in regulated environments like the cannabis testing industry.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2110\" target=\"_blank\">10 CFR Part 20.2110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51 (c-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5 and CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.22<\/b> The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(11)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.23<\/b> The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-2(10)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.24<\/b> The system should support single sign-on such that a user can log in once and access all permitted functions and data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.25<\/b> The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-4 and IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.26<\/b> The system shall prevent the same combination of identification components from being used across more than one account.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5 and IA-5(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.27<\/b> The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-2(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-4 and IA-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, PS-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.28<\/b> The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.29<\/b> The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.30<\/b> The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.31<\/b> The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.32<\/b> The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.33<\/b> The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188 (b-11)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (a-7 and a-8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (c-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.34<\/b> The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.35<\/b> The system shall support the ability to initially assign new individual users to system groups, roles, or both.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.36<\/b> The system shall force a user's electronic signature to be unique and traceable to a specific user's account.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.37<\/b> The system shall prevent the reuse or reassignment of a user's electronic signature.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.50\" target=\"_blank\">21 CFR Part 11.50<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.38<\/b> When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.39<\/b> The system should provide a means to migrate static data into the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.40<\/b> The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.41<\/b> The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._System_validation_and_commission\">24. System validation and commission<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.1<\/b> The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.2<\/b> The vendor should be willing to provide access to source code through a suitable escrow.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.3<\/b> The system should be able to document a summary and evaluation of enterprise performance markers and processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.4<\/b> The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.5<\/b> The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.3\u20137<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.6<\/b> The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._System_administration\">25. System administration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-11 and AC-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.1<\/b> The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.2<\/b> The system should provide a means for modifying personnel data in a batch.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.3<\/b> The system should support the storage and export of data in standard and industry-specific data formats, e.g., CSV, especially for regulatory reporting purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2 and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4 and PS-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.4<\/b> The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.5<\/b> The vendor should provide maintenance agreements and support services for its applications and services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.6<\/b> The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-5\u2013D-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.7<\/b> The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.8<\/b> The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.9<\/b> The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2(5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.10<\/b> The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.11<\/b> The system shall provide a means for migrating data to a new release upon system upgrade.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.12<\/b> The system should be expedient with the retrieval of stored items.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.13<\/b> The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.14<\/b> The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-3(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.15<\/b> The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"26._Cybersecurity\">26. Cybersecurity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4(6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-8 and SC-8(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.1<\/b> The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9(8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13 and SC-28(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.2<\/b> The system should support database encryption and be capable of recording the encryption status of the data contained within.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.3<\/b> The system should be able to support multifactor authentication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.202\" target=\"_blank\">45 CFR Part 170.202<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (h)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.4<\/b> The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information (e.g., medical marijuana user data).<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.5<\/b> The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.6<\/b> The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"27._Information_privacy\">27. Information privacy<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-2 and PT-2(2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.1<\/b> The system shall comply with privacy protection compliance like that found in HIPAA provisions (e.g., when handling medical marijuana user data).<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2106\" target=\"_blank\">10 CFR Part 20.2106 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-C\" target=\"_blank\">45 CFR Part 164 Subpart C<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-2 and PT-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.2<\/b> The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.3<\/b> The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.4<\/b> The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.5<\/b> The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-4 and PT-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.6<\/b> The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184910\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.086 seconds\nReal time usage: 0.097 seconds\nPreprocessor visited node count: 886\/1000000\nPost\u2010expand include size: 92860\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 26.435 1 -total\n 20.88% 5.519 1 Template:LIMSpec_for_Cannabis_Testing\/Configuration_management\n 18.46% 4.879 1 Template:LIMSpec_for_Cannabis_Testing\/Data_integrity\n 17.07% 4.512 1 Template:LIMSpec_for_Cannabis_Testing\/System_validation_and_commission\n 16.62% 4.393 1 Template:LIMSpec_for_Cannabis_Testing\/System_administration\n 12.14% 3.210 1 Template:LIMSpec_for_Cannabis_Testing\/Information_privacy\n 11.77% 3.112 1 Template:LIMSpec_for_Cannabis_Testing\/Cybersecurity\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5485-0!canonical and timestamp 20230623184910 and revision id 16580. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#26._Cybersecurity\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#26._Cybersecurity<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","61d27181a0110b64e94d66635bc8243e_images":[],"61d27181a0110b64e94d66635bc8243e_timestamp":1687546824,"9515befc43a8b2f2d37dfd402051cbe8_type":"article","9515befc43a8b2f2d37dfd402051cbe8_title":"25. System administration","9515befc43a8b2f2d37dfd402051cbe8_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#25._System_administration","9515befc43a8b2f2d37dfd402051cbe8_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Security and integrity of systems and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.\n\n22. Data integrity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-17-1\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 9.1\n\n\n22.1 System functionality should support ALCOA principles.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa ASTM E1578-18 E-17-2\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\n\n\n22.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa 42 CFR Part 93.305\r\n\n\u25aa 42 CFR Part 93.310\r\n\n\u25aa ASTM E1578-18 E-17-3\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.4.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.9\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.9\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n22.3 The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.30\r\n\n\u25aa 7 CFR Part 331.17 (c)\r\n\n\u25aa 9 CFR Part 2.35\r\n\n\u25aa 9 CFR Part 121.17 (c)\r\n\n\u25aa 10 CFR Part 20.2103\u201310\r\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 10 CFR Part 30.51\u20132\r\n\n\u25aa 21 CFR Part 1.1154 (a)\r\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.195\r\n\n\u25aa 21 CFR Part 106.100 (n)\r\n\n\u25aa 21 CFR Part 112.164\r\n\n\u25aa 21 CFR Part 114.100 (e)\r\n\n\u25aa 21 CFR Part 117.315\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.9\r\n\n\u25aa 21 CFR Part 129.80 (h)\r\n\n\u25aa 21 CFR Part 211.180\r\n\n\u25aa 21 CFR Part 212.110 (c)\r\n\n\u25aa 21 CFR Part 225.42 (b-8)\r\n\n\u25aa 21 CFR Part 225.58 (c\u2013d)\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 225.202\r\n\n\u25aa 21 CFR Part 226.42 (a)\r\n\n\u25aa 21 CFR Part 226.58 (f)\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 226.115\r\n\n\u25aa 21 CFR Part 312.57\r\n\n\u25aa 21 CFR Part 312.62\r\n\n\u25aa 21 CFR Part 507.208\r\n\n\u25aa 21 CFR Part 606.160 (d)\r\n\n\u25aa 21 CFR Part 812.140 (d)\r\n\n\u25aa 21 CFR Part 820.180 (b)\r\n\n\u25aa 29 CFR Part 1910.120 (f)(8)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 40 CFR Part 141.722\r\n\n\u25aa 40 CFR Part 262.11 (f)\r\n\n\u25aa 40 CFR Part 262.40\r\n\n\u25aa 40 CFR Part 262.213\r\n\n\u25aa 40 CFR Part 704 Subpart A\r\n\n\u25aa 40 CFR Part 717.15 (d)\r\n\n\u25aa 42 CFR Part 73.17 (c)\r\n\n\u25aa 42 CFR Part 93.313 (h)\r\n\n\u25aa 42 CFR Part 93.317\r\n\n\u25aa 42 CFR Part 493.1105\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa 45 CFR Part 164.105\r\n\n\u25aa 45 CFR Part 164.316\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa A2LA C223 5.9\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.2.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.3.2\r\n\n\u25aa ABFT Accreditation Manual Sec. E-33\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.6\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories E2.1\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.5.1\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7\r\n\n\u25aa ASTM E1578-18 E-17-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.2\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy 5.4.6\u20137\r\n\n\u25aa CJIS Security Policy 5.5.2.1\r\n\n\u25aa CLSI QMS22 2.8.3\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.4\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa E.U. Annex 11-7.1\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 15\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.18\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.17\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3\r\n\n\u25aa ICH GCP 4.9.5\r\n\n\u25aa IFS Food 7, Part 2, 2.1.2.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 2.1.2.2\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, AU-11 and AU-11(1)\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa OSHA 1910.1020(d)(1)(i\u2013ii)\r\n\n\u25aa OSHA 1910.1450(j)(2)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c\r\n\n\u25aa USDA Sampling Procedures for PDP 6.5\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.8\u20139\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1\n\n\n22.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-17-6\r\n\n\u25aa CJIS Security Policy 5.4.4\r\n\n\u25aa NIST 800-53, Rev. 5, AU-8\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n22.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-17-7\r\n\n\u25aa CJIS Security Policy 5.6.1\n\n\n22.6 The system shall require each and every user to be assigned a unique user ID.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-17-8\r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa CJIS Security Policy 5.4.5\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 4, AU-9\n\n\n22.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.4.2\r\n\u25aa NIST 800-53, Rev. 4, AU-5\r\n\u25aa NIST 800-53, Rev. 4, SI-4\n\n22.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\r\n \r\n\r\n \r\n\n\n\n\n23. Configuration management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 S-1-1\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n23.1 The system shall provide tools to enter and manage user-configurable lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-2\n\n23.2 The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and\/or state and local regulations, including for specific substrate\/matrix types.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 162.1002\r\n\u25aa USDA Sampling Procedures for PDP 6.3.2\n\n23.3 The system shall allow system nomenclature to be configured to use specific data code sets or mandated terminology to support the regulatory requirements of the cannabis testing industry.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-3\n\n23.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-4\n\n23.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.100 (b)\r\n\u25aa 21 CFR Part 211.160 (a)\n\n23.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 40 CFR Part 3.10\r\n\n\u25aa 40 CFR Part 3.2000\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\n\u25aa ASTM E1578-18 S-1-5\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-6\n\n23.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-7\n\n23.9 The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-8\n\n23.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of the cannabis testing laboratory workflow.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-1-9\n\n\n23.11 The system should allow authorized personnel to perform revision control of lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-10\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n23.12 The system should provide a means for importing lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa AIHA-LAP Policies 2018 2A.7.8.4\r\n\n\u25aa ASTM E1578-18 S-1-11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.6\r\n\n\u25aa USDA Data and Instrumentation for PDP 9.1\n\n\n23.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-12\n\n23.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-13\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\n\n\n23.15 The system should provide a clear alert or notification upon entry of out-of-specification results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-14\n\n23.16 The system shall allow authorized personnel to update static and dynamic data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-15\n\n23.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-17\r\n\n\u25aa CJIS Security Policy 5.7.1\r\n\n\u25aa NIST 800-53, Rev. 4, AC-6(1)\r\n\n\u25aa NIST 800-53, Rev. 4, CM-7\n\n\n23.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-18\r\n\u25aa CAP Laboratory Accreditation Manual\n\n23.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-19\n\n23.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa ASTM E1578-18 S-1-20\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 4, CM-5(1)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.21 The system should support rules governing electronic records and electronic signatures in regulated environments like the cannabis testing industry.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 10 CFR Part 20.2110\r\n\n\u25aa 10 CFR Part 30.51 (c-1\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa A2LA C211 4.13.1.4\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.4.1\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1492-11 4.2.4\r\n\n\u25aa ASTM E1578-18 S-1-16\r\n\n\u25aa ASTM E1578-18 S-1-21\r\n\n\u25aa CJIS Security Policy 5.5.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14\r\n\n\u25aa ICH GCP 2.10\r\n\n\u25aa ISO\/IEC 17025:2017 4.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5 and CM-5(1)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\n\n\n23.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa CJIS Security Policy 5.5.2.2\u20133\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(11)\n\n\n23.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-22\r\n\u25aa NIST 800-53, Rev. 4, IA-2(10)\n\n23.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CJIS Security Policy 5.6.1\r\n\n\u25aa CLSI QMS22 2.4.2.2\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.4\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (a)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 4, IA-4 and IA-5\n\n\n23.26 The system shall prevent the same combination of identification components from being used across more than one account.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (b)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-5 and IA-5(1)\n\n\n23.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa CJIS Security Policy 5.6.3.1\r\n\n\u25aa NIST 800-53, Rev. 4, AC-2(3)\r\n\n\u25aa NIST 800-53, Rev. 4, IA-4 and IA-5(1)\r\n\n\u25aa NIST 800-53, Rev. 4, PS-4\n\n\n23.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.2.2\r\n\u25aa NIST 800-53, Rev. 4, AC-10\n\n23.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.4\r\n\u25aa NIST 800-53, Rev. 4, AC-8\n\n23.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (d)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.4.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\n\n\n23.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (d)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CJIS Security Policy 5.5.3\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 4, AC-7\n\n\n23.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\u25aa ASTM E1578-18 S-3-1\n\n23.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 21 CFR Part 211.188 (b-11)\r\n\n\u25aa 21 CFR Part 211.194 (a-7 and a-8)\r\n\n\u25aa 21 CFR Part 212.50 (c-10)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa ASTM E1578-18 S-3-1\r\n\n\u25aa CJIS Security Policy 5.6.3.2\r\n\n\u25aa NIST 800-53, Rev. 5, IA-5\n\n\n23.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 S-1-25\r\n\n\u25aa CJIS Security Policy 5.5.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa NIST 800-53, Rev. 5, AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\n\n\n23.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa ASTM E1578-18 S-1-24\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10 and AU-10(3)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa ASTM E1578-18 S-1-24\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10 and AU-10(3)\n\n\n23.37 The system shall prevent the reuse or reassignment of a user's electronic signature.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.50\r\n\u25aa E.U. Annex 11-14\n\n23.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-26\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI QMS22 2.8.5.3\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.39 The system should provide a means to migrate static data into the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, IA-5(1)\r\n\u25aa CLSI QMS22 2.4.2\n\n23.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 4, IA-6\n\n23.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\r\n \r\n\r\n \r\n\n\n\n\n24. System validation and commission \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 S-2-1\r\n\n\u25aa CJIS Security Policy Appendix G.8\r\n\n\u25aa NIST 800-53, Rev. 5, SA-4(3)\n\n\n24.1 The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-2-2\r\n\u25aa NIST 800-53, Rev. 5, SA-4(2)\n\n24.2 The vendor should be willing to provide access to source code through a suitable escrow.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-2-3\n\n24.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa ASTM E1578-18 S-2-4\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.5\r\n\n\u25aa NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5\n\n\n24.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (a)\r\n\n\u25aa 21 CFR Part 820.70 (i)\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa E.U. Annex 11-11\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 10.2\n\n\n24.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-2-2\r\n\n\u25aa CLSI QMS22 2.5\r\n\n\u25aa E.U. Annex 11-4\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 10.3\u20137\n\n\n24.6 The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\r\n \r\n\r\n \r\n\n\n\n\n25. System administration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d-5)\r\n\n\u25aa ASTM E1578-18 S-3-1\r\n\n\u25aa CJIS Security Policy 5.5.5\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-11 and AC-12\n\n\n25.1 The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-2\n\n25.2 The system should provide a means for modifying personnel data in a batch.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-3\n\n25.3 The system should support the storage and export of data in standard and industry-specific data formats, e.g., CSV, especially for regulatory reporting purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-3-7\r\n\n\u25aa CJIS Security Policy 5.5.1\r\n\n\u25aa CJIS Security Policy 5.5.2.4\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa ISO 15189:2012 5.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2 and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\r\n\n\u25aa NIST 800-53, Rev. 5, PS-4 and PS-5\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5.1.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1\n\n\n25.4 The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-8\n\n25.5 The vendor should provide maintenance agreements and support services for its applications and services.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-3-9\r\n\n\u25aa E.U. Annex 11-3.3\r\n\n\u25aa NIST 800-53, Rev. 5, SA-16\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\n\n\n25.6 The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.4.3\r\n\n\u25aa ABFT Accreditation Manual Sec. D-5\u2013D-8\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1492-11 4.2.4\r\n\n\u25aa CJIS Security Policy 5.5.2\r\n\n\u25aa CJIS Security Policy 5.8.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.6\r\n\n\u25aa E.U. Annex 11-7.1\r\n\n\u25aa E.U. Annex 11-12\r\n\n\u25aa ISO 15189:2012 5.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa NIST 800-53, Rev. 5, MA-5\r\n\n\u25aa NIST 800-53, Rev. 5, MP-2\r\n\n\u25aa NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\n\n\n25.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.1\n\n25.8 The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1578-18 S-3-10\n\n\n25.9 The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-3-11\r\n\n\u25aa CJIS Security Policy 5.10.4.1\r\n\n\u25aa CLSI QMS22 2.1.4\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.13\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2(5)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n25.10 The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-12\n\n25.11 The system shall provide a means for migrating data to a new release upon system upgrade.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 1.1154 (b)\r\n\u25aa ASTM E1578-18 S-3-13\n\n25.12 The system should be expedient with the retrieval of stored items.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (b)\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa E.U. Annex 11-5\r\n\n\u25aa E.U. Annex 11-8.1\n\n\n25.13 The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-14\n\n25.14 The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-3-15\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-3(2)\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2\n\n\n25.15 The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\r\n \r\n\r\n \r\n\n\n\n\n26. Cybersecurity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d-9)\r\n\n\u25aa ASTM E1578-18 S-4-1\r\n\n\u25aa CJIS Security Policy 5.6.4\r\n\n\u25aa CJIS Security Policy 5.8.2.1\r\n\n\u25aa CJIS Security Policy 5.10.1.2\r\n\n\u25aa CJIS Security Policy Appendix G.6\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa NIST 800-53, Rev. 5, AC-17(2)\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4(6)\r\n\n\u25aa NIST 800-53, Rev. 5, SC-8 and SC-8(1)\n\n\n26.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.6\r\n\n\u25aa ASTM E1578-18 S-4-2\r\n\n\u25aa CJIS Security Policy 5.5.2.4\r\n\n\u25aa CJIS Security Policy 5.10.1.2\r\n\n\u25aa CJIS Security Policy Appendix G.6\r\n\n\u25aa NIST 800-53, Rev. 5, CP-9(8)\r\n\n\u25aa NIST 800-53, Rev. 5, SC-13 and SC-28(1)\n\n\n26.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa CJIS Security Policy 5.6.2.2.1\r\n\n\u25aa CLSI QMS22 2.4.2.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\n\n\n26.3 The system should be able to support multifactor authentication.\n\n\n\u25aa 45 CFR Part 170.202\r\n\u25aa 45 CFR Part 170.315 (h)\n\n26.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information (e.g., medical marijuana user data).\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, IA-7\n\n26.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, SC-15\n\n26.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\r\n \r\n\r\n \r\n\n\n\n\n27. Information privacy \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 45 CFR Part 164 Subpart E\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G17.2\r\n\n\u25aa ASTM E1578-18 S-5-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NIST 800-53, Rev. 5, PT-2 and PT-2(2)\n\n\n27.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions (e.g., when handling medical marijuana user data).\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2106 (d)\r\n\n\u25aa 45 CFR Part 164.105\r\n\n\u25aa 45 CFR Part 164 Subpart C\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 S-5-2\r\n\n\u25aa ICH GCP 2.11\r\n\n\u25aa NIST 800-53, Rev. 5, PT-2 and PT-2(2)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.3\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\n\n\n27.2 The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.5\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NIST 800-53, Rev. 5, SI-19\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3\n\n\n27.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 164 Subpart E\r\n\u25aa NIST 800-53, Rev. 5, AC-6\r\n\u25aa NIST 800-53, Rev. 5, SI-19\n\n27.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\r\n \r\n\r\n \r\n\n\n\nNIST 800-53, Rev. 5, SI-19(7)\n\n36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n\n\nNIST 800-53, Rev. 5, PT-4 and PT-4(3)\n\n36.6 The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#25._System_administration\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#25._System_administration<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 21 January 2021, at 21:17.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","9515befc43a8b2f2d37dfd402051cbe8_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Security_and_integrity_of_systems_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Security_and_integrity_of_systems_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Security and integrity of systems and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"22._Data_integrity\">22. Data integrity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.1<\/b> System functionality should support ALCOA principles.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.2<\/b> The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.305\" target=\"_blank\">42 CFR Part 93.305<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.310\" target=\"_blank\">42 CFR Part 93.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.3<\/b> The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.30\" target=\"_blank\">7 CFR Part 91.30<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.195\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (n)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.164<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.180\" target=\"_blank\">21 CFR Part 211.180<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 212.110 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42 (b-8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.115\" target=\"_blank\">21 CFR Part 226.115<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.208<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120 (f)(8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.722\" target=\"_blank\">40 CFR Part 141.722<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.11\" target=\"_blank\">40 CFR Part 262.11 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.40\" target=\"_blank\">40 CFR Part 262.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.213\" target=\"_blank\">40 CFR Part 262.213<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\/subpart-A\" target=\"_blank\">40 CFR Part 704 Subpart A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/717.15\" target=\"_blank\">40 CFR Part 717.15 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.313\" target=\"_blank\">42 CFR Part 93.313 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.317\" target=\"_blank\">42 CFR Part 93.317<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.316\" target=\"_blank\">45 CFR Part 164.316<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.4<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.18<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.1.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.1.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-11 and AU-11(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020(d)(1)(i\u2013ii)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(j)(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8\u20139<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.4<\/b> The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.5<\/b> The system shall accurately reflect the system date and time in its use of electronic record time stamps.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.6<\/b> The system shall require each and every user to be assigned a unique user ID.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.7<\/b> The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SI-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.8<\/b> The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Configuration_management\">23. Configuration management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.1<\/b> The system shall provide tools to enter and manage user-configurable lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.2<\/b> The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and\/or state and local regulations, including for specific substrate\/matrix types.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.1002\" target=\"_blank\">45 CFR Part 162.1002<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.3<\/b> The system shall allow system nomenclature to be configured to use specific data code sets or mandated terminology to support the regulatory requirements of the cannabis testing industry.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.4<\/b> The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.5<\/b> The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.6<\/b> The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.2000\" target=\"_blank\">40 CFR Part 3.2000<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.7<\/b> The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.8<\/b> The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.9<\/b> The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.10<\/b> The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of the cannabis testing laboratory workflow.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.11<\/b> The system should allow authorized personnel to perform revision control of lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-10<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.12<\/b> The system should provide a means for importing lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.13<\/b> The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.14<\/b> The system should allow calculated limits to be created and managed based on test results and relevant metadata.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.15<\/b> The system should provide a clear alert or notification upon entry of out-of-specification results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.16<\/b> The system shall allow authorized personnel to update static and dynamic data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.17<\/b> The system should allow workflow events and status changes to trigger one or more user-defined actions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.18<\/b> The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-18<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.19<\/b> The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-19<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.20<\/b> The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.21<\/b> The system should support rules governing electronic records and electronic signatures in regulated environments like the cannabis testing industry.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2110\" target=\"_blank\">10 CFR Part 20.2110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51 (c-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5 and CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.22<\/b> The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(11)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.23<\/b> The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-2(10)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.24<\/b> The system should support single sign-on such that a user can log in once and access all permitted functions and data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.25<\/b> The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-4 and IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.26<\/b> The system shall prevent the same combination of identification components from being used across more than one account.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5 and IA-5(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.27<\/b> The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-2(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-4 and IA-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, PS-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.28<\/b> The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.29<\/b> The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.30<\/b> The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.31<\/b> The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.32<\/b> The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.33<\/b> The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188 (b-11)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (a-7 and a-8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (c-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.34<\/b> The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.35<\/b> The system shall support the ability to initially assign new individual users to system groups, roles, or both.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.36<\/b> The system shall force a user's electronic signature to be unique and traceable to a specific user's account.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.37<\/b> The system shall prevent the reuse or reassignment of a user's electronic signature.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.50\" target=\"_blank\">21 CFR Part 11.50<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.38<\/b> When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.39<\/b> The system should provide a means to migrate static data into the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.40<\/b> The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.41<\/b> The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._System_validation_and_commission\">24. System validation and commission<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.1<\/b> The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.2<\/b> The vendor should be willing to provide access to source code through a suitable escrow.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.3<\/b> The system should be able to document a summary and evaluation of enterprise performance markers and processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.4<\/b> The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.5<\/b> The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.3\u20137<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.6<\/b> The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._System_administration\">25. System administration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-11 and AC-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.1<\/b> The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.2<\/b> The system should provide a means for modifying personnel data in a batch.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.3<\/b> The system should support the storage and export of data in standard and industry-specific data formats, e.g., CSV, especially for regulatory reporting purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2 and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4 and PS-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.4<\/b> The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.5<\/b> The vendor should provide maintenance agreements and support services for its applications and services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.6<\/b> The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-5\u2013D-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.7<\/b> The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.8<\/b> The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.9<\/b> The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2(5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.10<\/b> The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.11<\/b> The system shall provide a means for migrating data to a new release upon system upgrade.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.12<\/b> The system should be expedient with the retrieval of stored items.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.13<\/b> The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.14<\/b> The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-3(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.15<\/b> The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"26._Cybersecurity\">26. Cybersecurity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4(6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-8 and SC-8(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.1<\/b> The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9(8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13 and SC-28(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.2<\/b> The system should support database encryption and be capable of recording the encryption status of the data contained within.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.3<\/b> The system should be able to support multifactor authentication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.202\" target=\"_blank\">45 CFR Part 170.202<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (h)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.4<\/b> The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information (e.g., medical marijuana user data).<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.5<\/b> The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.6<\/b> The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"27._Information_privacy\">27. Information privacy<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-2 and PT-2(2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.1<\/b> The system shall comply with privacy protection compliance like that found in HIPAA provisions (e.g., when handling medical marijuana user data).<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2106\" target=\"_blank\">10 CFR Part 20.2106 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-C\" target=\"_blank\">45 CFR Part 164 Subpart C<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-2 and PT-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.2<\/b> The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.3<\/b> The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.4<\/b> The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.5<\/b> The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-4 and PT-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.6<\/b> The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184910\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.086 seconds\nReal time usage: 0.097 seconds\nPreprocessor visited node count: 886\/1000000\nPost\u2010expand include size: 92860\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 26.435 1 -total\n 20.88% 5.519 1 Template:LIMSpec_for_Cannabis_Testing\/Configuration_management\n 18.46% 4.879 1 Template:LIMSpec_for_Cannabis_Testing\/Data_integrity\n 17.07% 4.512 1 Template:LIMSpec_for_Cannabis_Testing\/System_validation_and_commission\n 16.62% 4.393 1 Template:LIMSpec_for_Cannabis_Testing\/System_administration\n 12.14% 3.210 1 Template:LIMSpec_for_Cannabis_Testing\/Information_privacy\n 11.77% 3.112 1 Template:LIMSpec_for_Cannabis_Testing\/Cybersecurity\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5485-0!canonical and timestamp 20230623184910 and revision id 16580. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#25._System_administration\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#25._System_administration<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","9515befc43a8b2f2d37dfd402051cbe8_images":[],"9515befc43a8b2f2d37dfd402051cbe8_timestamp":1687546823,"d5cc68f93e213baf479f862b1dabd159_type":"article","d5cc68f93e213baf479f862b1dabd159_title":"24. System validation and commission","d5cc68f93e213baf479f862b1dabd159_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#24._System_validation_and_commission","d5cc68f93e213baf479f862b1dabd159_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Security and integrity of systems and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.\n\n22. Data integrity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-17-1\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 9.1\n\n\n22.1 System functionality should support ALCOA principles.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa ASTM E1578-18 E-17-2\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\n\n\n22.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa 42 CFR Part 93.305\r\n\n\u25aa 42 CFR Part 93.310\r\n\n\u25aa ASTM E1578-18 E-17-3\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.4.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.9\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.9\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n22.3 The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.30\r\n\n\u25aa 7 CFR Part 331.17 (c)\r\n\n\u25aa 9 CFR Part 2.35\r\n\n\u25aa 9 CFR Part 121.17 (c)\r\n\n\u25aa 10 CFR Part 20.2103\u201310\r\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 10 CFR Part 30.51\u20132\r\n\n\u25aa 21 CFR Part 1.1154 (a)\r\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.195\r\n\n\u25aa 21 CFR Part 106.100 (n)\r\n\n\u25aa 21 CFR Part 112.164\r\n\n\u25aa 21 CFR Part 114.100 (e)\r\n\n\u25aa 21 CFR Part 117.315\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.9\r\n\n\u25aa 21 CFR Part 129.80 (h)\r\n\n\u25aa 21 CFR Part 211.180\r\n\n\u25aa 21 CFR Part 212.110 (c)\r\n\n\u25aa 21 CFR Part 225.42 (b-8)\r\n\n\u25aa 21 CFR Part 225.58 (c\u2013d)\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 225.202\r\n\n\u25aa 21 CFR Part 226.42 (a)\r\n\n\u25aa 21 CFR Part 226.58 (f)\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 226.115\r\n\n\u25aa 21 CFR Part 312.57\r\n\n\u25aa 21 CFR Part 312.62\r\n\n\u25aa 21 CFR Part 507.208\r\n\n\u25aa 21 CFR Part 606.160 (d)\r\n\n\u25aa 21 CFR Part 812.140 (d)\r\n\n\u25aa 21 CFR Part 820.180 (b)\r\n\n\u25aa 29 CFR Part 1910.120 (f)(8)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 40 CFR Part 141.722\r\n\n\u25aa 40 CFR Part 262.11 (f)\r\n\n\u25aa 40 CFR Part 262.40\r\n\n\u25aa 40 CFR Part 262.213\r\n\n\u25aa 40 CFR Part 704 Subpart A\r\n\n\u25aa 40 CFR Part 717.15 (d)\r\n\n\u25aa 42 CFR Part 73.17 (c)\r\n\n\u25aa 42 CFR Part 93.313 (h)\r\n\n\u25aa 42 CFR Part 93.317\r\n\n\u25aa 42 CFR Part 493.1105\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa 45 CFR Part 164.105\r\n\n\u25aa 45 CFR Part 164.316\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa A2LA C223 5.9\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.2.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.3.2\r\n\n\u25aa ABFT Accreditation Manual Sec. E-33\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.6\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories E2.1\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.5.1\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7\r\n\n\u25aa ASTM E1578-18 E-17-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.2\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy 5.4.6\u20137\r\n\n\u25aa CJIS Security Policy 5.5.2.1\r\n\n\u25aa CLSI QMS22 2.8.3\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.4\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa E.U. Annex 11-7.1\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 15\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.18\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.17\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3\r\n\n\u25aa ICH GCP 4.9.5\r\n\n\u25aa IFS Food 7, Part 2, 2.1.2.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 2.1.2.2\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, AU-11 and AU-11(1)\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa OSHA 1910.1020(d)(1)(i\u2013ii)\r\n\n\u25aa OSHA 1910.1450(j)(2)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c\r\n\n\u25aa USDA Sampling Procedures for PDP 6.5\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.8\u20139\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1\n\n\n22.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-17-6\r\n\n\u25aa CJIS Security Policy 5.4.4\r\n\n\u25aa NIST 800-53, Rev. 5, AU-8\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n22.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-17-7\r\n\n\u25aa CJIS Security Policy 5.6.1\n\n\n22.6 The system shall require each and every user to be assigned a unique user ID.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-17-8\r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa CJIS Security Policy 5.4.5\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 4, AU-9\n\n\n22.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.4.2\r\n\u25aa NIST 800-53, Rev. 4, AU-5\r\n\u25aa NIST 800-53, Rev. 4, SI-4\n\n22.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\r\n \r\n\r\n \r\n\n\n\n\n23. Configuration management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 S-1-1\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n23.1 The system shall provide tools to enter and manage user-configurable lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-2\n\n23.2 The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and\/or state and local regulations, including for specific substrate\/matrix types.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 162.1002\r\n\u25aa USDA Sampling Procedures for PDP 6.3.2\n\n23.3 The system shall allow system nomenclature to be configured to use specific data code sets or mandated terminology to support the regulatory requirements of the cannabis testing industry.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-3\n\n23.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-4\n\n23.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.100 (b)\r\n\u25aa 21 CFR Part 211.160 (a)\n\n23.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 40 CFR Part 3.10\r\n\n\u25aa 40 CFR Part 3.2000\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\n\u25aa ASTM E1578-18 S-1-5\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-6\n\n23.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-7\n\n23.9 The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-8\n\n23.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of the cannabis testing laboratory workflow.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-1-9\n\n\n23.11 The system should allow authorized personnel to perform revision control of lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-10\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n23.12 The system should provide a means for importing lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa AIHA-LAP Policies 2018 2A.7.8.4\r\n\n\u25aa ASTM E1578-18 S-1-11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.6\r\n\n\u25aa USDA Data and Instrumentation for PDP 9.1\n\n\n23.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-12\n\n23.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-13\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\n\n\n23.15 The system should provide a clear alert or notification upon entry of out-of-specification results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-14\n\n23.16 The system shall allow authorized personnel to update static and dynamic data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-15\n\n23.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-17\r\n\n\u25aa CJIS Security Policy 5.7.1\r\n\n\u25aa NIST 800-53, Rev. 4, AC-6(1)\r\n\n\u25aa NIST 800-53, Rev. 4, CM-7\n\n\n23.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-18\r\n\u25aa CAP Laboratory Accreditation Manual\n\n23.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-19\n\n23.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa ASTM E1578-18 S-1-20\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 4, CM-5(1)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.21 The system should support rules governing electronic records and electronic signatures in regulated environments like the cannabis testing industry.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 10 CFR Part 20.2110\r\n\n\u25aa 10 CFR Part 30.51 (c-1\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa A2LA C211 4.13.1.4\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.4.1\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1492-11 4.2.4\r\n\n\u25aa ASTM E1578-18 S-1-16\r\n\n\u25aa ASTM E1578-18 S-1-21\r\n\n\u25aa CJIS Security Policy 5.5.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14\r\n\n\u25aa ICH GCP 2.10\r\n\n\u25aa ISO\/IEC 17025:2017 4.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5 and CM-5(1)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\n\n\n23.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa CJIS Security Policy 5.5.2.2\u20133\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(11)\n\n\n23.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-22\r\n\u25aa NIST 800-53, Rev. 4, IA-2(10)\n\n23.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CJIS Security Policy 5.6.1\r\n\n\u25aa CLSI QMS22 2.4.2.2\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.4\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (a)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 4, IA-4 and IA-5\n\n\n23.26 The system shall prevent the same combination of identification components from being used across more than one account.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (b)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-5 and IA-5(1)\n\n\n23.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa CJIS Security Policy 5.6.3.1\r\n\n\u25aa NIST 800-53, Rev. 4, AC-2(3)\r\n\n\u25aa NIST 800-53, Rev. 4, IA-4 and IA-5(1)\r\n\n\u25aa NIST 800-53, Rev. 4, PS-4\n\n\n23.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.2.2\r\n\u25aa NIST 800-53, Rev. 4, AC-10\n\n23.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.4\r\n\u25aa NIST 800-53, Rev. 4, AC-8\n\n23.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (d)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.4.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\n\n\n23.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (d)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CJIS Security Policy 5.5.3\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 4, AC-7\n\n\n23.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\u25aa ASTM E1578-18 S-3-1\n\n23.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 21 CFR Part 211.188 (b-11)\r\n\n\u25aa 21 CFR Part 211.194 (a-7 and a-8)\r\n\n\u25aa 21 CFR Part 212.50 (c-10)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa ASTM E1578-18 S-3-1\r\n\n\u25aa CJIS Security Policy 5.6.3.2\r\n\n\u25aa NIST 800-53, Rev. 5, IA-5\n\n\n23.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 S-1-25\r\n\n\u25aa CJIS Security Policy 5.5.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa NIST 800-53, Rev. 5, AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\n\n\n23.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa ASTM E1578-18 S-1-24\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10 and AU-10(3)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa ASTM E1578-18 S-1-24\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10 and AU-10(3)\n\n\n23.37 The system shall prevent the reuse or reassignment of a user's electronic signature.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.50\r\n\u25aa E.U. Annex 11-14\n\n23.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-26\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI QMS22 2.8.5.3\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.39 The system should provide a means to migrate static data into the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, IA-5(1)\r\n\u25aa CLSI QMS22 2.4.2\n\n23.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 4, IA-6\n\n23.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\r\n \r\n\r\n \r\n\n\n\n\n24. System validation and commission \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 S-2-1\r\n\n\u25aa CJIS Security Policy Appendix G.8\r\n\n\u25aa NIST 800-53, Rev. 5, SA-4(3)\n\n\n24.1 The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-2-2\r\n\u25aa NIST 800-53, Rev. 5, SA-4(2)\n\n24.2 The vendor should be willing to provide access to source code through a suitable escrow.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-2-3\n\n24.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa ASTM E1578-18 S-2-4\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.5\r\n\n\u25aa NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5\n\n\n24.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (a)\r\n\n\u25aa 21 CFR Part 820.70 (i)\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa E.U. Annex 11-11\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 10.2\n\n\n24.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-2-2\r\n\n\u25aa CLSI QMS22 2.5\r\n\n\u25aa E.U. Annex 11-4\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 10.3\u20137\n\n\n24.6 The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\r\n \r\n\r\n \r\n\n\n\n\n25. System administration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d-5)\r\n\n\u25aa ASTM E1578-18 S-3-1\r\n\n\u25aa CJIS Security Policy 5.5.5\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-11 and AC-12\n\n\n25.1 The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-2\n\n25.2 The system should provide a means for modifying personnel data in a batch.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-3\n\n25.3 The system should support the storage and export of data in standard and industry-specific data formats, e.g., CSV, especially for regulatory reporting purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-3-7\r\n\n\u25aa CJIS Security Policy 5.5.1\r\n\n\u25aa CJIS Security Policy 5.5.2.4\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa ISO 15189:2012 5.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2 and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\r\n\n\u25aa NIST 800-53, Rev. 5, PS-4 and PS-5\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5.1.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1\n\n\n25.4 The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-8\n\n25.5 The vendor should provide maintenance agreements and support services for its applications and services.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-3-9\r\n\n\u25aa E.U. Annex 11-3.3\r\n\n\u25aa NIST 800-53, Rev. 5, SA-16\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\n\n\n25.6 The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.4.3\r\n\n\u25aa ABFT Accreditation Manual Sec. D-5\u2013D-8\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1492-11 4.2.4\r\n\n\u25aa CJIS Security Policy 5.5.2\r\n\n\u25aa CJIS Security Policy 5.8.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.6\r\n\n\u25aa E.U. Annex 11-7.1\r\n\n\u25aa E.U. Annex 11-12\r\n\n\u25aa ISO 15189:2012 5.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa NIST 800-53, Rev. 5, MA-5\r\n\n\u25aa NIST 800-53, Rev. 5, MP-2\r\n\n\u25aa NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\n\n\n25.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.1\n\n25.8 The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1578-18 S-3-10\n\n\n25.9 The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-3-11\r\n\n\u25aa CJIS Security Policy 5.10.4.1\r\n\n\u25aa CLSI QMS22 2.1.4\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.13\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2(5)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n25.10 The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-12\n\n25.11 The system shall provide a means for migrating data to a new release upon system upgrade.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 1.1154 (b)\r\n\u25aa ASTM E1578-18 S-3-13\n\n25.12 The system should be expedient with the retrieval of stored items.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (b)\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa E.U. Annex 11-5\r\n\n\u25aa E.U. Annex 11-8.1\n\n\n25.13 The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-14\n\n25.14 The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-3-15\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-3(2)\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2\n\n\n25.15 The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\r\n \r\n\r\n \r\n\n\n\n\n26. Cybersecurity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d-9)\r\n\n\u25aa ASTM E1578-18 S-4-1\r\n\n\u25aa CJIS Security Policy 5.6.4\r\n\n\u25aa CJIS Security Policy 5.8.2.1\r\n\n\u25aa CJIS Security Policy 5.10.1.2\r\n\n\u25aa CJIS Security Policy Appendix G.6\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa NIST 800-53, Rev. 5, AC-17(2)\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4(6)\r\n\n\u25aa NIST 800-53, Rev. 5, SC-8 and SC-8(1)\n\n\n26.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.6\r\n\n\u25aa ASTM E1578-18 S-4-2\r\n\n\u25aa CJIS Security Policy 5.5.2.4\r\n\n\u25aa CJIS Security Policy 5.10.1.2\r\n\n\u25aa CJIS Security Policy Appendix G.6\r\n\n\u25aa NIST 800-53, Rev. 5, CP-9(8)\r\n\n\u25aa NIST 800-53, Rev. 5, SC-13 and SC-28(1)\n\n\n26.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa CJIS Security Policy 5.6.2.2.1\r\n\n\u25aa CLSI QMS22 2.4.2.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\n\n\n26.3 The system should be able to support multifactor authentication.\n\n\n\u25aa 45 CFR Part 170.202\r\n\u25aa 45 CFR Part 170.315 (h)\n\n26.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information (e.g., medical marijuana user data).\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, IA-7\n\n26.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, SC-15\n\n26.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\r\n \r\n\r\n \r\n\n\n\n\n27. Information privacy \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 45 CFR Part 164 Subpart E\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G17.2\r\n\n\u25aa ASTM E1578-18 S-5-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NIST 800-53, Rev. 5, PT-2 and PT-2(2)\n\n\n27.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions (e.g., when handling medical marijuana user data).\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2106 (d)\r\n\n\u25aa 45 CFR Part 164.105\r\n\n\u25aa 45 CFR Part 164 Subpart C\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 S-5-2\r\n\n\u25aa ICH GCP 2.11\r\n\n\u25aa NIST 800-53, Rev. 5, PT-2 and PT-2(2)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.3\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\n\n\n27.2 The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.5\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NIST 800-53, Rev. 5, SI-19\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3\n\n\n27.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 164 Subpart E\r\n\u25aa NIST 800-53, Rev. 5, AC-6\r\n\u25aa NIST 800-53, Rev. 5, SI-19\n\n27.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\r\n \r\n\r\n \r\n\n\n\nNIST 800-53, Rev. 5, SI-19(7)\n\n36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n\n\nNIST 800-53, Rev. 5, PT-4 and PT-4(3)\n\n36.6 The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#24._System_validation_and_commission\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#24._System_validation_and_commission<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 21 January 2021, at 21:17.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","d5cc68f93e213baf479f862b1dabd159_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Security_and_integrity_of_systems_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Security_and_integrity_of_systems_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Security and integrity of systems and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"22._Data_integrity\">22. Data integrity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.1<\/b> System functionality should support ALCOA principles.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.2<\/b> The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.305\" target=\"_blank\">42 CFR Part 93.305<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.310\" target=\"_blank\">42 CFR Part 93.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.3<\/b> The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.30\" target=\"_blank\">7 CFR Part 91.30<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.195\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (n)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.164<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.180\" target=\"_blank\">21 CFR Part 211.180<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 212.110 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42 (b-8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.115\" target=\"_blank\">21 CFR Part 226.115<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.208<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120 (f)(8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.722\" target=\"_blank\">40 CFR Part 141.722<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.11\" target=\"_blank\">40 CFR Part 262.11 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.40\" target=\"_blank\">40 CFR Part 262.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.213\" target=\"_blank\">40 CFR Part 262.213<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\/subpart-A\" target=\"_blank\">40 CFR Part 704 Subpart A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/717.15\" target=\"_blank\">40 CFR Part 717.15 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.313\" target=\"_blank\">42 CFR Part 93.313 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.317\" target=\"_blank\">42 CFR Part 93.317<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.316\" target=\"_blank\">45 CFR Part 164.316<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.4<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.18<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.1.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.1.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-11 and AU-11(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020(d)(1)(i\u2013ii)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(j)(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8\u20139<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.4<\/b> The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.5<\/b> The system shall accurately reflect the system date and time in its use of electronic record time stamps.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.6<\/b> The system shall require each and every user to be assigned a unique user ID.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.7<\/b> The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SI-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.8<\/b> The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Configuration_management\">23. Configuration management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.1<\/b> The system shall provide tools to enter and manage user-configurable lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.2<\/b> The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and\/or state and local regulations, including for specific substrate\/matrix types.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.1002\" target=\"_blank\">45 CFR Part 162.1002<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.3<\/b> The system shall allow system nomenclature to be configured to use specific data code sets or mandated terminology to support the regulatory requirements of the cannabis testing industry.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.4<\/b> The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.5<\/b> The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.6<\/b> The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.2000\" target=\"_blank\">40 CFR Part 3.2000<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.7<\/b> The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.8<\/b> The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.9<\/b> The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.10<\/b> The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of the cannabis testing laboratory workflow.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.11<\/b> The system should allow authorized personnel to perform revision control of lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-10<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.12<\/b> The system should provide a means for importing lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.13<\/b> The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.14<\/b> The system should allow calculated limits to be created and managed based on test results and relevant metadata.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.15<\/b> The system should provide a clear alert or notification upon entry of out-of-specification results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.16<\/b> The system shall allow authorized personnel to update static and dynamic data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.17<\/b> The system should allow workflow events and status changes to trigger one or more user-defined actions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.18<\/b> The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-18<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.19<\/b> The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-19<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.20<\/b> The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.21<\/b> The system should support rules governing electronic records and electronic signatures in regulated environments like the cannabis testing industry.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2110\" target=\"_blank\">10 CFR Part 20.2110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51 (c-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5 and CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.22<\/b> The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(11)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.23<\/b> The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-2(10)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.24<\/b> The system should support single sign-on such that a user can log in once and access all permitted functions and data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.25<\/b> The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-4 and IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.26<\/b> The system shall prevent the same combination of identification components from being used across more than one account.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5 and IA-5(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.27<\/b> The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-2(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-4 and IA-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, PS-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.28<\/b> The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.29<\/b> The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.30<\/b> The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.31<\/b> The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.32<\/b> The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.33<\/b> The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188 (b-11)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (a-7 and a-8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (c-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.34<\/b> The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.35<\/b> The system shall support the ability to initially assign new individual users to system groups, roles, or both.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.36<\/b> The system shall force a user's electronic signature to be unique and traceable to a specific user's account.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.37<\/b> The system shall prevent the reuse or reassignment of a user's electronic signature.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.50\" target=\"_blank\">21 CFR Part 11.50<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.38<\/b> When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.39<\/b> The system should provide a means to migrate static data into the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.40<\/b> The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.41<\/b> The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._System_validation_and_commission\">24. System validation and commission<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.1<\/b> The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.2<\/b> The vendor should be willing to provide access to source code through a suitable escrow.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.3<\/b> The system should be able to document a summary and evaluation of enterprise performance markers and processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.4<\/b> The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.5<\/b> The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.3\u20137<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.6<\/b> The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._System_administration\">25. System administration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-11 and AC-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.1<\/b> The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.2<\/b> The system should provide a means for modifying personnel data in a batch.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.3<\/b> The system should support the storage and export of data in standard and industry-specific data formats, e.g., CSV, especially for regulatory reporting purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2 and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4 and PS-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.4<\/b> The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.5<\/b> The vendor should provide maintenance agreements and support services for its applications and services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.6<\/b> The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-5\u2013D-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.7<\/b> The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.8<\/b> The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.9<\/b> The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2(5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.10<\/b> The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.11<\/b> The system shall provide a means for migrating data to a new release upon system upgrade.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.12<\/b> The system should be expedient with the retrieval of stored items.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.13<\/b> The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.14<\/b> The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-3(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.15<\/b> The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"26._Cybersecurity\">26. Cybersecurity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4(6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-8 and SC-8(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.1<\/b> The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9(8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13 and SC-28(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.2<\/b> The system should support database encryption and be capable of recording the encryption status of the data contained within.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.3<\/b> The system should be able to support multifactor authentication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.202\" target=\"_blank\">45 CFR Part 170.202<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (h)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.4<\/b> The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information (e.g., medical marijuana user data).<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.5<\/b> The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.6<\/b> The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"27._Information_privacy\">27. Information privacy<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-2 and PT-2(2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.1<\/b> The system shall comply with privacy protection compliance like that found in HIPAA provisions (e.g., when handling medical marijuana user data).<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2106\" target=\"_blank\">10 CFR Part 20.2106 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-C\" target=\"_blank\">45 CFR Part 164 Subpart C<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-2 and PT-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.2<\/b> The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.3<\/b> The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.4<\/b> The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.5<\/b> The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-4 and PT-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.6<\/b> The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184910\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.086 seconds\nReal time usage: 0.097 seconds\nPreprocessor visited node count: 886\/1000000\nPost\u2010expand include size: 92860\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 26.435 1 -total\n 20.88% 5.519 1 Template:LIMSpec_for_Cannabis_Testing\/Configuration_management\n 18.46% 4.879 1 Template:LIMSpec_for_Cannabis_Testing\/Data_integrity\n 17.07% 4.512 1 Template:LIMSpec_for_Cannabis_Testing\/System_validation_and_commission\n 16.62% 4.393 1 Template:LIMSpec_for_Cannabis_Testing\/System_administration\n 12.14% 3.210 1 Template:LIMSpec_for_Cannabis_Testing\/Information_privacy\n 11.77% 3.112 1 Template:LIMSpec_for_Cannabis_Testing\/Cybersecurity\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5485-0!canonical and timestamp 20230623184910 and revision id 16580. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#24._System_validation_and_commission\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#24._System_validation_and_commission<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","d5cc68f93e213baf479f862b1dabd159_images":[],"d5cc68f93e213baf479f862b1dabd159_timestamp":1687546823,"14c1d5a48d0eb9c071c15fd69d497a80_type":"article","14c1d5a48d0eb9c071c15fd69d497a80_title":"23. Configuration management","14c1d5a48d0eb9c071c15fd69d497a80_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#23._Configuration_management","14c1d5a48d0eb9c071c15fd69d497a80_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Security and integrity of systems and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.\n\n22. Data integrity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-17-1\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 9.1\n\n\n22.1 System functionality should support ALCOA principles.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa ASTM E1578-18 E-17-2\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\n\n\n22.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa 42 CFR Part 93.305\r\n\n\u25aa 42 CFR Part 93.310\r\n\n\u25aa ASTM E1578-18 E-17-3\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.4.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.9\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.9\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n22.3 The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.30\r\n\n\u25aa 7 CFR Part 331.17 (c)\r\n\n\u25aa 9 CFR Part 2.35\r\n\n\u25aa 9 CFR Part 121.17 (c)\r\n\n\u25aa 10 CFR Part 20.2103\u201310\r\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 10 CFR Part 30.51\u20132\r\n\n\u25aa 21 CFR Part 1.1154 (a)\r\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.195\r\n\n\u25aa 21 CFR Part 106.100 (n)\r\n\n\u25aa 21 CFR Part 112.164\r\n\n\u25aa 21 CFR Part 114.100 (e)\r\n\n\u25aa 21 CFR Part 117.315\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.9\r\n\n\u25aa 21 CFR Part 129.80 (h)\r\n\n\u25aa 21 CFR Part 211.180\r\n\n\u25aa 21 CFR Part 212.110 (c)\r\n\n\u25aa 21 CFR Part 225.42 (b-8)\r\n\n\u25aa 21 CFR Part 225.58 (c\u2013d)\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 225.202\r\n\n\u25aa 21 CFR Part 226.42 (a)\r\n\n\u25aa 21 CFR Part 226.58 (f)\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 226.115\r\n\n\u25aa 21 CFR Part 312.57\r\n\n\u25aa 21 CFR Part 312.62\r\n\n\u25aa 21 CFR Part 507.208\r\n\n\u25aa 21 CFR Part 606.160 (d)\r\n\n\u25aa 21 CFR Part 812.140 (d)\r\n\n\u25aa 21 CFR Part 820.180 (b)\r\n\n\u25aa 29 CFR Part 1910.120 (f)(8)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 40 CFR Part 141.722\r\n\n\u25aa 40 CFR Part 262.11 (f)\r\n\n\u25aa 40 CFR Part 262.40\r\n\n\u25aa 40 CFR Part 262.213\r\n\n\u25aa 40 CFR Part 704 Subpart A\r\n\n\u25aa 40 CFR Part 717.15 (d)\r\n\n\u25aa 42 CFR Part 73.17 (c)\r\n\n\u25aa 42 CFR Part 93.313 (h)\r\n\n\u25aa 42 CFR Part 93.317\r\n\n\u25aa 42 CFR Part 493.1105\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa 45 CFR Part 164.105\r\n\n\u25aa 45 CFR Part 164.316\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa A2LA C223 5.9\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.2.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.3.2\r\n\n\u25aa ABFT Accreditation Manual Sec. E-33\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.6\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories E2.1\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.5.1\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7\r\n\n\u25aa ASTM E1578-18 E-17-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.2\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy 5.4.6\u20137\r\n\n\u25aa CJIS Security Policy 5.5.2.1\r\n\n\u25aa CLSI QMS22 2.8.3\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.4\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa E.U. Annex 11-7.1\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 15\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.18\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.17\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3\r\n\n\u25aa ICH GCP 4.9.5\r\n\n\u25aa IFS Food 7, Part 2, 2.1.2.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 2.1.2.2\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, AU-11 and AU-11(1)\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa OSHA 1910.1020(d)(1)(i\u2013ii)\r\n\n\u25aa OSHA 1910.1450(j)(2)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c\r\n\n\u25aa USDA Sampling Procedures for PDP 6.5\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.8\u20139\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1\n\n\n22.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-17-6\r\n\n\u25aa CJIS Security Policy 5.4.4\r\n\n\u25aa NIST 800-53, Rev. 5, AU-8\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n22.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-17-7\r\n\n\u25aa CJIS Security Policy 5.6.1\n\n\n22.6 The system shall require each and every user to be assigned a unique user ID.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-17-8\r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa CJIS Security Policy 5.4.5\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 4, AU-9\n\n\n22.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.4.2\r\n\u25aa NIST 800-53, Rev. 4, AU-5\r\n\u25aa NIST 800-53, Rev. 4, SI-4\n\n22.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\r\n \r\n\r\n \r\n\n\n\n\n23. Configuration management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 S-1-1\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n23.1 The system shall provide tools to enter and manage user-configurable lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-2\n\n23.2 The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and\/or state and local regulations, including for specific substrate\/matrix types.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 162.1002\r\n\u25aa USDA Sampling Procedures for PDP 6.3.2\n\n23.3 The system shall allow system nomenclature to be configured to use specific data code sets or mandated terminology to support the regulatory requirements of the cannabis testing industry.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-3\n\n23.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-4\n\n23.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.100 (b)\r\n\u25aa 21 CFR Part 211.160 (a)\n\n23.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 40 CFR Part 3.10\r\n\n\u25aa 40 CFR Part 3.2000\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\n\u25aa ASTM E1578-18 S-1-5\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-6\n\n23.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-7\n\n23.9 The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-8\n\n23.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of the cannabis testing laboratory workflow.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-1-9\n\n\n23.11 The system should allow authorized personnel to perform revision control of lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-10\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n23.12 The system should provide a means for importing lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa AIHA-LAP Policies 2018 2A.7.8.4\r\n\n\u25aa ASTM E1578-18 S-1-11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.6\r\n\n\u25aa USDA Data and Instrumentation for PDP 9.1\n\n\n23.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-12\n\n23.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-13\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\n\n\n23.15 The system should provide a clear alert or notification upon entry of out-of-specification results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-14\n\n23.16 The system shall allow authorized personnel to update static and dynamic data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-15\n\n23.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-17\r\n\n\u25aa CJIS Security Policy 5.7.1\r\n\n\u25aa NIST 800-53, Rev. 4, AC-6(1)\r\n\n\u25aa NIST 800-53, Rev. 4, CM-7\n\n\n23.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-18\r\n\u25aa CAP Laboratory Accreditation Manual\n\n23.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-19\n\n23.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa ASTM E1578-18 S-1-20\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 4, CM-5(1)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.21 The system should support rules governing electronic records and electronic signatures in regulated environments like the cannabis testing industry.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 10 CFR Part 20.2110\r\n\n\u25aa 10 CFR Part 30.51 (c-1\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa A2LA C211 4.13.1.4\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.4.1\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1492-11 4.2.4\r\n\n\u25aa ASTM E1578-18 S-1-16\r\n\n\u25aa ASTM E1578-18 S-1-21\r\n\n\u25aa CJIS Security Policy 5.5.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14\r\n\n\u25aa ICH GCP 2.10\r\n\n\u25aa ISO\/IEC 17025:2017 4.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5 and CM-5(1)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\n\n\n23.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa CJIS Security Policy 5.5.2.2\u20133\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(11)\n\n\n23.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-22\r\n\u25aa NIST 800-53, Rev. 4, IA-2(10)\n\n23.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CJIS Security Policy 5.6.1\r\n\n\u25aa CLSI QMS22 2.4.2.2\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.4\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (a)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 4, IA-4 and IA-5\n\n\n23.26 The system shall prevent the same combination of identification components from being used across more than one account.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (b)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-5 and IA-5(1)\n\n\n23.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa CJIS Security Policy 5.6.3.1\r\n\n\u25aa NIST 800-53, Rev. 4, AC-2(3)\r\n\n\u25aa NIST 800-53, Rev. 4, IA-4 and IA-5(1)\r\n\n\u25aa NIST 800-53, Rev. 4, PS-4\n\n\n23.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.2.2\r\n\u25aa NIST 800-53, Rev. 4, AC-10\n\n23.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.4\r\n\u25aa NIST 800-53, Rev. 4, AC-8\n\n23.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (d)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.4.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\n\n\n23.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (d)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CJIS Security Policy 5.5.3\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 4, AC-7\n\n\n23.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\u25aa ASTM E1578-18 S-3-1\n\n23.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 21 CFR Part 211.188 (b-11)\r\n\n\u25aa 21 CFR Part 211.194 (a-7 and a-8)\r\n\n\u25aa 21 CFR Part 212.50 (c-10)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa ASTM E1578-18 S-3-1\r\n\n\u25aa CJIS Security Policy 5.6.3.2\r\n\n\u25aa NIST 800-53, Rev. 5, IA-5\n\n\n23.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 S-1-25\r\n\n\u25aa CJIS Security Policy 5.5.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa NIST 800-53, Rev. 5, AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\n\n\n23.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa ASTM E1578-18 S-1-24\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10 and AU-10(3)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa ASTM E1578-18 S-1-24\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10 and AU-10(3)\n\n\n23.37 The system shall prevent the reuse or reassignment of a user's electronic signature.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.50\r\n\u25aa E.U. Annex 11-14\n\n23.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-26\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI QMS22 2.8.5.3\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.39 The system should provide a means to migrate static data into the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, IA-5(1)\r\n\u25aa CLSI QMS22 2.4.2\n\n23.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 4, IA-6\n\n23.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\r\n \r\n\r\n \r\n\n\n\n\n24. System validation and commission \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 S-2-1\r\n\n\u25aa CJIS Security Policy Appendix G.8\r\n\n\u25aa NIST 800-53, Rev. 5, SA-4(3)\n\n\n24.1 The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-2-2\r\n\u25aa NIST 800-53, Rev. 5, SA-4(2)\n\n24.2 The vendor should be willing to provide access to source code through a suitable escrow.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-2-3\n\n24.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa ASTM E1578-18 S-2-4\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.5\r\n\n\u25aa NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5\n\n\n24.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (a)\r\n\n\u25aa 21 CFR Part 820.70 (i)\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa E.U. Annex 11-11\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 10.2\n\n\n24.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-2-2\r\n\n\u25aa CLSI QMS22 2.5\r\n\n\u25aa E.U. Annex 11-4\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 10.3\u20137\n\n\n24.6 The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\r\n \r\n\r\n \r\n\n\n\n\n25. System administration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d-5)\r\n\n\u25aa ASTM E1578-18 S-3-1\r\n\n\u25aa CJIS Security Policy 5.5.5\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-11 and AC-12\n\n\n25.1 The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-2\n\n25.2 The system should provide a means for modifying personnel data in a batch.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-3\n\n25.3 The system should support the storage and export of data in standard and industry-specific data formats, e.g., CSV, especially for regulatory reporting purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-3-7\r\n\n\u25aa CJIS Security Policy 5.5.1\r\n\n\u25aa CJIS Security Policy 5.5.2.4\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa ISO 15189:2012 5.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2 and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\r\n\n\u25aa NIST 800-53, Rev. 5, PS-4 and PS-5\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5.1.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1\n\n\n25.4 The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-8\n\n25.5 The vendor should provide maintenance agreements and support services for its applications and services.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-3-9\r\n\n\u25aa E.U. Annex 11-3.3\r\n\n\u25aa NIST 800-53, Rev. 5, SA-16\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\n\n\n25.6 The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.4.3\r\n\n\u25aa ABFT Accreditation Manual Sec. D-5\u2013D-8\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1492-11 4.2.4\r\n\n\u25aa CJIS Security Policy 5.5.2\r\n\n\u25aa CJIS Security Policy 5.8.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.6\r\n\n\u25aa E.U. Annex 11-7.1\r\n\n\u25aa E.U. Annex 11-12\r\n\n\u25aa ISO 15189:2012 5.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa NIST 800-53, Rev. 5, MA-5\r\n\n\u25aa NIST 800-53, Rev. 5, MP-2\r\n\n\u25aa NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\n\n\n25.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.1\n\n25.8 The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1578-18 S-3-10\n\n\n25.9 The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-3-11\r\n\n\u25aa CJIS Security Policy 5.10.4.1\r\n\n\u25aa CLSI QMS22 2.1.4\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.13\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2(5)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n25.10 The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-12\n\n25.11 The system shall provide a means for migrating data to a new release upon system upgrade.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 1.1154 (b)\r\n\u25aa ASTM E1578-18 S-3-13\n\n25.12 The system should be expedient with the retrieval of stored items.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (b)\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa E.U. Annex 11-5\r\n\n\u25aa E.U. Annex 11-8.1\n\n\n25.13 The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-14\n\n25.14 The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-3-15\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-3(2)\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2\n\n\n25.15 The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\r\n \r\n\r\n \r\n\n\n\n\n26. Cybersecurity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d-9)\r\n\n\u25aa ASTM E1578-18 S-4-1\r\n\n\u25aa CJIS Security Policy 5.6.4\r\n\n\u25aa CJIS Security Policy 5.8.2.1\r\n\n\u25aa CJIS Security Policy 5.10.1.2\r\n\n\u25aa CJIS Security Policy Appendix G.6\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa NIST 800-53, Rev. 5, AC-17(2)\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4(6)\r\n\n\u25aa NIST 800-53, Rev. 5, SC-8 and SC-8(1)\n\n\n26.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.6\r\n\n\u25aa ASTM E1578-18 S-4-2\r\n\n\u25aa CJIS Security Policy 5.5.2.4\r\n\n\u25aa CJIS Security Policy 5.10.1.2\r\n\n\u25aa CJIS Security Policy Appendix G.6\r\n\n\u25aa NIST 800-53, Rev. 5, CP-9(8)\r\n\n\u25aa NIST 800-53, Rev. 5, SC-13 and SC-28(1)\n\n\n26.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa CJIS Security Policy 5.6.2.2.1\r\n\n\u25aa CLSI QMS22 2.4.2.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\n\n\n26.3 The system should be able to support multifactor authentication.\n\n\n\u25aa 45 CFR Part 170.202\r\n\u25aa 45 CFR Part 170.315 (h)\n\n26.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information (e.g., medical marijuana user data).\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, IA-7\n\n26.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, SC-15\n\n26.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\r\n \r\n\r\n \r\n\n\n\n\n27. Information privacy \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 45 CFR Part 164 Subpart E\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G17.2\r\n\n\u25aa ASTM E1578-18 S-5-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NIST 800-53, Rev. 5, PT-2 and PT-2(2)\n\n\n27.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions (e.g., when handling medical marijuana user data).\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2106 (d)\r\n\n\u25aa 45 CFR Part 164.105\r\n\n\u25aa 45 CFR Part 164 Subpart C\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 S-5-2\r\n\n\u25aa ICH GCP 2.11\r\n\n\u25aa NIST 800-53, Rev. 5, PT-2 and PT-2(2)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.3\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\n\n\n27.2 The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.5\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NIST 800-53, Rev. 5, SI-19\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3\n\n\n27.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 164 Subpart E\r\n\u25aa NIST 800-53, Rev. 5, AC-6\r\n\u25aa NIST 800-53, Rev. 5, SI-19\n\n27.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\r\n \r\n\r\n \r\n\n\n\nNIST 800-53, Rev. 5, SI-19(7)\n\n36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n\n\nNIST 800-53, Rev. 5, PT-4 and PT-4(3)\n\n36.6 The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#23._Configuration_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#23._Configuration_management<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 21 January 2021, at 21:17.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","14c1d5a48d0eb9c071c15fd69d497a80_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Security_and_integrity_of_systems_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Security_and_integrity_of_systems_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Security and integrity of systems and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"22._Data_integrity\">22. Data integrity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.1<\/b> System functionality should support ALCOA principles.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.2<\/b> The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.305\" target=\"_blank\">42 CFR Part 93.305<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.310\" target=\"_blank\">42 CFR Part 93.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.3<\/b> The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.30\" target=\"_blank\">7 CFR Part 91.30<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.195\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (n)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.164<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.180\" target=\"_blank\">21 CFR Part 211.180<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 212.110 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42 (b-8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.115\" target=\"_blank\">21 CFR Part 226.115<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.208<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120 (f)(8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.722\" target=\"_blank\">40 CFR Part 141.722<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.11\" target=\"_blank\">40 CFR Part 262.11 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.40\" target=\"_blank\">40 CFR Part 262.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.213\" target=\"_blank\">40 CFR Part 262.213<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\/subpart-A\" target=\"_blank\">40 CFR Part 704 Subpart A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/717.15\" target=\"_blank\">40 CFR Part 717.15 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.313\" target=\"_blank\">42 CFR Part 93.313 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.317\" target=\"_blank\">42 CFR Part 93.317<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.316\" target=\"_blank\">45 CFR Part 164.316<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.4<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.18<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.1.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.1.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-11 and AU-11(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020(d)(1)(i\u2013ii)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(j)(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8\u20139<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.4<\/b> The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.5<\/b> The system shall accurately reflect the system date and time in its use of electronic record time stamps.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.6<\/b> The system shall require each and every user to be assigned a unique user ID.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.7<\/b> The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SI-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.8<\/b> The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Configuration_management\">23. Configuration management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.1<\/b> The system shall provide tools to enter and manage user-configurable lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.2<\/b> The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and\/or state and local regulations, including for specific substrate\/matrix types.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.1002\" target=\"_blank\">45 CFR Part 162.1002<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.3<\/b> The system shall allow system nomenclature to be configured to use specific data code sets or mandated terminology to support the regulatory requirements of the cannabis testing industry.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.4<\/b> The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.5<\/b> The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.6<\/b> The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.2000\" target=\"_blank\">40 CFR Part 3.2000<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.7<\/b> The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.8<\/b> The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.9<\/b> The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.10<\/b> The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of the cannabis testing laboratory workflow.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.11<\/b> The system should allow authorized personnel to perform revision control of lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-10<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.12<\/b> The system should provide a means for importing lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.13<\/b> The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.14<\/b> The system should allow calculated limits to be created and managed based on test results and relevant metadata.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.15<\/b> The system should provide a clear alert or notification upon entry of out-of-specification results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.16<\/b> The system shall allow authorized personnel to update static and dynamic data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.17<\/b> The system should allow workflow events and status changes to trigger one or more user-defined actions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.18<\/b> The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-18<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.19<\/b> The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-19<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.20<\/b> The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.21<\/b> The system should support rules governing electronic records and electronic signatures in regulated environments like the cannabis testing industry.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2110\" target=\"_blank\">10 CFR Part 20.2110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51 (c-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5 and CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.22<\/b> The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(11)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.23<\/b> The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-2(10)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.24<\/b> The system should support single sign-on such that a user can log in once and access all permitted functions and data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.25<\/b> The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-4 and IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.26<\/b> The system shall prevent the same combination of identification components from being used across more than one account.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5 and IA-5(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.27<\/b> The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-2(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-4 and IA-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, PS-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.28<\/b> The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.29<\/b> The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.30<\/b> The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.31<\/b> The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.32<\/b> The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.33<\/b> The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188 (b-11)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (a-7 and a-8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (c-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.34<\/b> The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.35<\/b> The system shall support the ability to initially assign new individual users to system groups, roles, or both.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.36<\/b> The system shall force a user's electronic signature to be unique and traceable to a specific user's account.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.37<\/b> The system shall prevent the reuse or reassignment of a user's electronic signature.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.50\" target=\"_blank\">21 CFR Part 11.50<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.38<\/b> When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.39<\/b> The system should provide a means to migrate static data into the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.40<\/b> The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.41<\/b> The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._System_validation_and_commission\">24. System validation and commission<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.1<\/b> The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.2<\/b> The vendor should be willing to provide access to source code through a suitable escrow.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.3<\/b> The system should be able to document a summary and evaluation of enterprise performance markers and processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.4<\/b> The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.5<\/b> The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.3\u20137<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.6<\/b> The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._System_administration\">25. System administration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-11 and AC-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.1<\/b> The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.2<\/b> The system should provide a means for modifying personnel data in a batch.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.3<\/b> The system should support the storage and export of data in standard and industry-specific data formats, e.g., CSV, especially for regulatory reporting purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2 and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4 and PS-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.4<\/b> The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.5<\/b> The vendor should provide maintenance agreements and support services for its applications and services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.6<\/b> The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-5\u2013D-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.7<\/b> The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.8<\/b> The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.9<\/b> The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2(5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.10<\/b> The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.11<\/b> The system shall provide a means for migrating data to a new release upon system upgrade.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.12<\/b> The system should be expedient with the retrieval of stored items.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.13<\/b> The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.14<\/b> The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-3(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.15<\/b> The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"26._Cybersecurity\">26. Cybersecurity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4(6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-8 and SC-8(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.1<\/b> The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9(8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13 and SC-28(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.2<\/b> The system should support database encryption and be capable of recording the encryption status of the data contained within.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.3<\/b> The system should be able to support multifactor authentication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.202\" target=\"_blank\">45 CFR Part 170.202<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (h)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.4<\/b> The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information (e.g., medical marijuana user data).<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.5<\/b> The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.6<\/b> The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"27._Information_privacy\">27. Information privacy<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-2 and PT-2(2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.1<\/b> The system shall comply with privacy protection compliance like that found in HIPAA provisions (e.g., when handling medical marijuana user data).<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2106\" target=\"_blank\">10 CFR Part 20.2106 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-C\" target=\"_blank\">45 CFR Part 164 Subpart C<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-2 and PT-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.2<\/b> The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.3<\/b> The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.4<\/b> The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.5<\/b> The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-4 and PT-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.6<\/b> The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184910\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.086 seconds\nReal time usage: 0.097 seconds\nPreprocessor visited node count: 886\/1000000\nPost\u2010expand include size: 92860\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 26.435 1 -total\n 20.88% 5.519 1 Template:LIMSpec_for_Cannabis_Testing\/Configuration_management\n 18.46% 4.879 1 Template:LIMSpec_for_Cannabis_Testing\/Data_integrity\n 17.07% 4.512 1 Template:LIMSpec_for_Cannabis_Testing\/System_validation_and_commission\n 16.62% 4.393 1 Template:LIMSpec_for_Cannabis_Testing\/System_administration\n 12.14% 3.210 1 Template:LIMSpec_for_Cannabis_Testing\/Information_privacy\n 11.77% 3.112 1 Template:LIMSpec_for_Cannabis_Testing\/Cybersecurity\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5485-0!canonical and timestamp 20230623184910 and revision id 16580. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#23._Configuration_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#23._Configuration_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","14c1d5a48d0eb9c071c15fd69d497a80_images":[],"14c1d5a48d0eb9c071c15fd69d497a80_timestamp":1687546823,"89117ffb5f5c45e6c58390fd71119767_type":"article","89117ffb5f5c45e6c58390fd71119767_title":"22. Data integrity","89117ffb5f5c45e6c58390fd71119767_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#22._Data_integrity","89117ffb5f5c45e6c58390fd71119767_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Security and integrity of systems and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.\n\n22. Data integrity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-17-1\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 9.1\n\n\n22.1 System functionality should support ALCOA principles.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa ASTM E1578-18 E-17-2\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\n\n\n22.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa 42 CFR Part 93.305\r\n\n\u25aa 42 CFR Part 93.310\r\n\n\u25aa ASTM E1578-18 E-17-3\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.4.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.9\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.9\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n22.3 The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.30\r\n\n\u25aa 7 CFR Part 331.17 (c)\r\n\n\u25aa 9 CFR Part 2.35\r\n\n\u25aa 9 CFR Part 121.17 (c)\r\n\n\u25aa 10 CFR Part 20.2103\u201310\r\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 10 CFR Part 30.51\u20132\r\n\n\u25aa 21 CFR Part 1.1154 (a)\r\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.195\r\n\n\u25aa 21 CFR Part 106.100 (n)\r\n\n\u25aa 21 CFR Part 112.164\r\n\n\u25aa 21 CFR Part 114.100 (e)\r\n\n\u25aa 21 CFR Part 117.315\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.9\r\n\n\u25aa 21 CFR Part 129.80 (h)\r\n\n\u25aa 21 CFR Part 211.180\r\n\n\u25aa 21 CFR Part 212.110 (c)\r\n\n\u25aa 21 CFR Part 225.42 (b-8)\r\n\n\u25aa 21 CFR Part 225.58 (c\u2013d)\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 225.202\r\n\n\u25aa 21 CFR Part 226.42 (a)\r\n\n\u25aa 21 CFR Part 226.58 (f)\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 226.115\r\n\n\u25aa 21 CFR Part 312.57\r\n\n\u25aa 21 CFR Part 312.62\r\n\n\u25aa 21 CFR Part 507.208\r\n\n\u25aa 21 CFR Part 606.160 (d)\r\n\n\u25aa 21 CFR Part 812.140 (d)\r\n\n\u25aa 21 CFR Part 820.180 (b)\r\n\n\u25aa 29 CFR Part 1910.120 (f)(8)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 40 CFR Part 141.722\r\n\n\u25aa 40 CFR Part 262.11 (f)\r\n\n\u25aa 40 CFR Part 262.40\r\n\n\u25aa 40 CFR Part 262.213\r\n\n\u25aa 40 CFR Part 704 Subpart A\r\n\n\u25aa 40 CFR Part 717.15 (d)\r\n\n\u25aa 42 CFR Part 73.17 (c)\r\n\n\u25aa 42 CFR Part 93.313 (h)\r\n\n\u25aa 42 CFR Part 93.317\r\n\n\u25aa 42 CFR Part 493.1105\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa 45 CFR Part 164.105\r\n\n\u25aa 45 CFR Part 164.316\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa A2LA C223 5.9\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.2.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.3.2\r\n\n\u25aa ABFT Accreditation Manual Sec. E-33\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.6\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories E2.1\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.5.1\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7\r\n\n\u25aa ASTM E1578-18 E-17-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.2\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy 5.4.6\u20137\r\n\n\u25aa CJIS Security Policy 5.5.2.1\r\n\n\u25aa CLSI QMS22 2.8.3\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.4\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa E.U. Annex 11-7.1\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 15\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.18\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.17\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3\r\n\n\u25aa ICH GCP 4.9.5\r\n\n\u25aa IFS Food 7, Part 2, 2.1.2.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 2.1.2.2\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, AU-11 and AU-11(1)\r\n\n\u25aa NIST 800-53, Rev. 5, SI-12\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa OSHA 1910.1020(d)(1)(i\u2013ii)\r\n\n\u25aa OSHA 1910.1450(j)(2)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c\r\n\n\u25aa USDA Sampling Procedures for PDP 6.5\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.8\u20139\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1\n\n\n22.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-17-6\r\n\n\u25aa CJIS Security Policy 5.4.4\r\n\n\u25aa NIST 800-53, Rev. 5, AU-8\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n22.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-17-7\r\n\n\u25aa CJIS Security Policy 5.6.1\n\n\n22.6 The system shall require each and every user to be assigned a unique user ID.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-17-8\r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa CJIS Security Policy 5.4.5\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 4, AU-9\n\n\n22.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.4.2\r\n\u25aa NIST 800-53, Rev. 4, AU-5\r\n\u25aa NIST 800-53, Rev. 4, SI-4\n\n22.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\r\n \r\n\r\n \r\n\n\n\n\n23. Configuration management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 S-1-1\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n23.1 The system shall provide tools to enter and manage user-configurable lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-2\n\n23.2 The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and\/or state and local regulations, including for specific substrate\/matrix types.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 162.1002\r\n\u25aa USDA Sampling Procedures for PDP 6.3.2\n\n23.3 The system shall allow system nomenclature to be configured to use specific data code sets or mandated terminology to support the regulatory requirements of the cannabis testing industry.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-3\n\n23.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-4\n\n23.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.100 (b)\r\n\u25aa 21 CFR Part 211.160 (a)\n\n23.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 40 CFR Part 3.10\r\n\n\u25aa 40 CFR Part 3.2000\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\n\u25aa ASTM E1578-18 S-1-5\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-6\n\n23.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-7\n\n23.9 The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-8\n\n23.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of the cannabis testing laboratory workflow.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-1-9\n\n\n23.11 The system should allow authorized personnel to perform revision control of lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-10\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n23.12 The system should provide a means for importing lookup or master data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa AIHA-LAP Policies 2018 2A.7.8.4\r\n\n\u25aa ASTM E1578-18 S-1-11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.6\r\n\n\u25aa USDA Data and Instrumentation for PDP 9.1\n\n\n23.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-12\n\n23.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-13\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\n\n\n23.15 The system should provide a clear alert or notification upon entry of out-of-specification results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-14\n\n23.16 The system shall allow authorized personnel to update static and dynamic data.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-15\n\n23.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-17\r\n\n\u25aa CJIS Security Policy 5.7.1\r\n\n\u25aa NIST 800-53, Rev. 4, AC-6(1)\r\n\n\u25aa NIST 800-53, Rev. 4, CM-7\n\n\n23.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-18\r\n\u25aa CAP Laboratory Accreditation Manual\n\n23.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-19\n\n23.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa ASTM E1578-18 S-1-20\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 4, CM-5(1)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.21 The system should support rules governing electronic records and electronic signatures in regulated environments like the cannabis testing industry.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 10 CFR Part 20.2110\r\n\n\u25aa 10 CFR Part 30.51 (c-1\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa A2LA C211 4.13.1.4\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.4.1\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1492-11 4.2.4\r\n\n\u25aa ASTM E1578-18 S-1-16\r\n\n\u25aa ASTM E1578-18 S-1-21\r\n\n\u25aa CJIS Security Policy 5.5.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14\r\n\n\u25aa ICH GCP 2.10\r\n\n\u25aa ISO\/IEC 17025:2017 4.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5 and CM-5(1)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\n\n\n23.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa CJIS Security Policy 5.5.2.2\u20133\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(11)\n\n\n23.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-1-22\r\n\u25aa NIST 800-53, Rev. 4, IA-2(10)\n\n23.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CJIS Security Policy 5.6.1\r\n\n\u25aa CLSI QMS22 2.4.2.2\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.4\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (a)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 4, IA-4 and IA-5\n\n\n23.26 The system shall prevent the same combination of identification components from being used across more than one account.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (b)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-5 and IA-5(1)\n\n\n23.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa CJIS Security Policy 5.6.3.1\r\n\n\u25aa NIST 800-53, Rev. 4, AC-2(3)\r\n\n\u25aa NIST 800-53, Rev. 4, IA-4 and IA-5(1)\r\n\n\u25aa NIST 800-53, Rev. 4, PS-4\n\n\n23.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.2.2\r\n\u25aa NIST 800-53, Rev. 4, AC-10\n\n23.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.4\r\n\u25aa NIST 800-53, Rev. 4, AC-8\n\n23.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (d)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.4.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\n\n\n23.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.300 (d)\r\n\n\u25aa ASTM E1578-18 E17-5 and S-3-1\r\n\n\u25aa CJIS Security Policy 5.5.3\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 4, AC-7\n\n\n23.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\u25aa ASTM E1578-18 S-3-1\n\n23.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 21 CFR Part 211.188 (b-11)\r\n\n\u25aa 21 CFR Part 211.194 (a-7 and a-8)\r\n\n\u25aa 21 CFR Part 212.50 (c-10)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa ASTM E1578-18 S-3-1\r\n\n\u25aa CJIS Security Policy 5.6.3.2\r\n\n\u25aa NIST 800-53, Rev. 5, IA-5\n\n\n23.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 S-1-25\r\n\n\u25aa CJIS Security Policy 5.5.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa NIST 800-53, Rev. 5, AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\n\n\n23.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa ASTM E1578-18 S-1-24\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10 and AU-10(3)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.100 (a)\r\n\n\u25aa ASTM E1578-18 S-1-24\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10 and AU-10(3)\n\n\n23.37 The system shall prevent the reuse or reassignment of a user's electronic signature.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.50\r\n\u25aa E.U. Annex 11-14\n\n23.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-1-26\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI QMS22 2.8.5.3\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n23.39 The system should provide a means to migrate static data into the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, IA-5(1)\r\n\u25aa CLSI QMS22 2.4.2\n\n23.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 4, IA-6\n\n23.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\r\n \r\n\r\n \r\n\n\n\n\n24. System validation and commission \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 S-2-1\r\n\n\u25aa CJIS Security Policy Appendix G.8\r\n\n\u25aa NIST 800-53, Rev. 5, SA-4(3)\n\n\n24.1 The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-2-2\r\n\u25aa NIST 800-53, Rev. 5, SA-4(2)\n\n24.2 The vendor should be willing to provide access to source code through a suitable escrow.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-2-3\n\n24.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa ASTM E1578-18 S-2-4\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.5\r\n\n\u25aa NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5\n\n\n24.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (a)\r\n\n\u25aa 21 CFR Part 820.70 (i)\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa E.U. Annex 11-11\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 10.2\n\n\n24.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-2-2\r\n\n\u25aa CLSI QMS22 2.5\r\n\n\u25aa E.U. Annex 11-4\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 10.3\u20137\n\n\n24.6 The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\r\n \r\n\r\n \r\n\n\n\n\n25. System administration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 11.200 (a)\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d-5)\r\n\n\u25aa ASTM E1578-18 S-3-1\r\n\n\u25aa CJIS Security Policy 5.5.5\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-11 and AC-12\n\n\n25.1 The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-2\n\n25.2 The system should provide a means for modifying personnel data in a batch.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-3\n\n25.3 The system should support the storage and export of data in standard and industry-specific data formats, e.g., CSV, especially for regulatory reporting purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (d)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-3-7\r\n\n\u25aa CJIS Security Policy 5.5.1\r\n\n\u25aa CJIS Security Policy 5.5.2.4\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\n\u25aa ISO 15189:2012 5.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2 and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\r\n\n\u25aa NIST 800-53, Rev. 5, PS-4 and PS-5\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5.1.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1\n\n\n25.4 The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-8\n\n25.5 The vendor should provide maintenance agreements and support services for its applications and services.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-3-9\r\n\n\u25aa E.U. Annex 11-3.3\r\n\n\u25aa NIST 800-53, Rev. 5, SA-16\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\n\n\n25.6 The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.4.3\r\n\n\u25aa ABFT Accreditation Manual Sec. D-5\u2013D-8\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\n\u25aa ASTM E1492-11 4.2.4\r\n\n\u25aa CJIS Security Policy 5.5.2\r\n\n\u25aa CJIS Security Policy 5.8.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.6\r\n\n\u25aa E.U. Annex 11-7.1\r\n\n\u25aa E.U. Annex 11-12\r\n\n\u25aa ISO 15189:2012 5.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.11.3\r\n\n\u25aa NIST 800-53, Rev. 5, MA-5\r\n\n\u25aa NIST 800-53, Rev. 5, MP-2\r\n\n\u25aa NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\n\n\n25.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\r\n \r\n\r\n \r\n\n\n\n\u25aa CJIS Security Policy 5.5.1\n\n25.8 The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1578-18 S-3-10\n\n\n25.9 The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 S-3-11\r\n\n\u25aa CJIS Security Policy 5.10.4.1\r\n\n\u25aa CLSI QMS22 2.1.4\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.13\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2(5)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n25.10 The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-12\n\n25.11 The system shall provide a means for migrating data to a new release upon system upgrade.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 1.1154 (b)\r\n\u25aa ASTM E1578-18 S-3-13\n\n25.12 The system should be expedient with the retrieval of stored items.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (b)\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa E.U. Annex 11-5\r\n\n\u25aa E.U. Annex 11-8.1\n\n\n25.13 The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 S-3-14\n\n25.14 The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 S-3-15\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-3(2)\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2\n\n\n25.15 The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\r\n \r\n\r\n \r\n\n\n\n\n26. Cybersecurity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d-9)\r\n\n\u25aa ASTM E1578-18 S-4-1\r\n\n\u25aa CJIS Security Policy 5.6.4\r\n\n\u25aa CJIS Security Policy 5.8.2.1\r\n\n\u25aa CJIS Security Policy 5.10.1.2\r\n\n\u25aa CJIS Security Policy Appendix G.6\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa NIST 800-53, Rev. 5, AC-17(2)\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4(6)\r\n\n\u25aa NIST 800-53, Rev. 5, SC-8 and SC-8(1)\n\n\n26.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa 45 CFR Part 164.312\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.6\r\n\n\u25aa ASTM E1578-18 S-4-2\r\n\n\u25aa CJIS Security Policy 5.5.2.4\r\n\n\u25aa CJIS Security Policy 5.10.1.2\r\n\n\u25aa CJIS Security Policy Appendix G.6\r\n\n\u25aa NIST 800-53, Rev. 5, CP-9(8)\r\n\n\u25aa NIST 800-53, Rev. 5, SC-13 and SC-28(1)\n\n\n26.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1231\r\n\n\u25aa CJIS Security Policy 5.6.2.2.1\r\n\n\u25aa CLSI QMS22 2.4.2.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-3\r\n\n\u25aa NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-4\n\n\n26.3 The system should be able to support multifactor authentication.\n\n\n\u25aa 45 CFR Part 170.202\r\n\u25aa 45 CFR Part 170.315 (h)\n\n26.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information (e.g., medical marijuana user data).\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, IA-7\n\n26.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\r\n \r\n\r\n \r\n\n\n\n\u25aa NIST 800-53, Rev. 5, SC-15\n\n26.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\r\n \r\n\r\n \r\n\n\n\n\n27. Information privacy \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 45 CFR Part 164 Subpart E\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G17.2\r\n\n\u25aa ASTM E1578-18 S-5-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NIST 800-53, Rev. 5, PT-2 and PT-2(2)\n\n\n27.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions (e.g., when handling medical marijuana user data).\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2106 (d)\r\n\n\u25aa 45 CFR Part 164.105\r\n\n\u25aa 45 CFR Part 164 Subpart C\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 S-5-2\r\n\n\u25aa ICH GCP 2.11\r\n\n\u25aa NIST 800-53, Rev. 5, PT-2 and PT-2(2)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.3\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\n\n\n27.2 The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 45 CFR Part 164.514\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.5\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NIST 800-53, Rev. 5, SI-19\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3\n\n\n27.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 164 Subpart E\r\n\u25aa NIST 800-53, Rev. 5, AC-6\r\n\u25aa NIST 800-53, Rev. 5, SI-19\n\n27.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\r\n \r\n\r\n \r\n\n\n\nNIST 800-53, Rev. 5, SI-19(7)\n\n36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n\n\nNIST 800-53, Rev. 5, PT-4 and PT-4(3)\n\n36.6 The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#22._Data_integrity\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#22._Data_integrity<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 21 January 2021, at 21:17.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","89117ffb5f5c45e6c58390fd71119767_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Security_and_integrity_of_systems_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Security_and_integrity_of_systems_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Security and integrity of systems and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"22._Data_integrity\">22. Data integrity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.1<\/b> System functionality should support ALCOA principles.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.2<\/b> The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.305\" target=\"_blank\">42 CFR Part 93.305<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.310\" target=\"_blank\">42 CFR Part 93.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.3<\/b> The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.30\" target=\"_blank\">7 CFR Part 91.30<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.195\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (n)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.164<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.180\" target=\"_blank\">21 CFR Part 211.180<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 212.110 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42 (b-8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.115\" target=\"_blank\">21 CFR Part 226.115<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.208<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120 (f)(8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.722\" target=\"_blank\">40 CFR Part 141.722<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.11\" target=\"_blank\">40 CFR Part 262.11 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.40\" target=\"_blank\">40 CFR Part 262.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.213\" target=\"_blank\">40 CFR Part 262.213<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\/subpart-A\" target=\"_blank\">40 CFR Part 704 Subpart A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/717.15\" target=\"_blank\">40 CFR Part 717.15 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.313\" target=\"_blank\">42 CFR Part 93.313 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.317\" target=\"_blank\">42 CFR Part 93.317<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.316\" target=\"_blank\">45 CFR Part 164.316<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.4<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.18<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.1.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.1.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-11 and AU-11(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020(d)(1)(i\u2013ii)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(j)(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8\u20139<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.4<\/b> The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.5<\/b> The system shall accurately reflect the system date and time in its use of electronic record time stamps.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.6<\/b> The system shall require each and every user to be assigned a unique user ID.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.7<\/b> The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SI-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>22.8<\/b> The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"23._Configuration_management\">23. Configuration management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.1<\/b> The system shall provide tools to enter and manage user-configurable lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.2<\/b> The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and\/or state and local regulations, including for specific substrate\/matrix types.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.1002\" target=\"_blank\">45 CFR Part 162.1002<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.3<\/b> The system shall allow system nomenclature to be configured to use specific data code sets or mandated terminology to support the regulatory requirements of the cannabis testing industry.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.4<\/b> The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.5<\/b> The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.6<\/b> The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.2000\" target=\"_blank\">40 CFR Part 3.2000<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.7<\/b> The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.8<\/b> The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.9<\/b> The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.10<\/b> The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of the cannabis testing laboratory workflow.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.11<\/b> The system should allow authorized personnel to perform revision control of lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-10<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.12<\/b> The system should provide a means for importing lookup or master data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.13<\/b> The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.14<\/b> The system should allow calculated limits to be created and managed based on test results and relevant metadata.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.15<\/b> The system should provide a clear alert or notification upon entry of out-of-specification results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.16<\/b> The system shall allow authorized personnel to update static and dynamic data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.17<\/b> The system should allow workflow events and status changes to trigger one or more user-defined actions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.18<\/b> The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-18<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.19<\/b> The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-19<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.20<\/b> The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.21<\/b> The system should support rules governing electronic records and electronic signatures in regulated environments like the cannabis testing industry.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2110\" target=\"_blank\">10 CFR Part 20.2110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51 (c-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5 and CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.22<\/b> The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(11)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.23<\/b> The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-2(10)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.24<\/b> The system should support single sign-on such that a user can log in once and access all permitted functions and data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.25<\/b> The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-4 and IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.26<\/b> The system shall prevent the same combination of identification components from being used across more than one account.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5 and IA-5(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.27<\/b> The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-2(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-4 and IA-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, PS-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.28<\/b> The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.29<\/b> The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.30<\/b> The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.31<\/b> The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.32<\/b> The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.33<\/b> The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188 (b-11)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (a-7 and a-8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (c-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.34<\/b> The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.35<\/b> The system shall support the ability to initially assign new individual users to system groups, roles, or both.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.36<\/b> The system shall force a user's electronic signature to be unique and traceable to a specific user's account.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.37<\/b> The system shall prevent the reuse or reassignment of a user's electronic signature.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.50\" target=\"_blank\">21 CFR Part 11.50<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.38<\/b> When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.39<\/b> The system should provide a means to migrate static data into the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.40<\/b> The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>23.41<\/b> The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"24._System_validation_and_commission\">24. System validation and commission<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.1<\/b> The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.2<\/b> The vendor should be willing to provide access to source code through a suitable escrow.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.3<\/b> The system should be able to document a summary and evaluation of enterprise performance markers and processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.4<\/b> The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.5<\/b> The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.3\u20137<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>24.6<\/b> The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"25._System_administration\">25. System administration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-11 and AC-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.1<\/b> The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.2<\/b> The system should provide a means for modifying personnel data in a batch.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.3<\/b> The system should support the storage and export of data in standard and industry-specific data formats, e.g., CSV, especially for regulatory reporting purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2 and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4 and PS-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.4<\/b> The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.5<\/b> The vendor should provide maintenance agreements and support services for its applications and services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.6<\/b> The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-5\u2013D-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.7<\/b> The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.8<\/b> The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.9<\/b> The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2(5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.10<\/b> The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.11<\/b> The system shall provide a means for migrating data to a new release upon system upgrade.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.12<\/b> The system should be expedient with the retrieval of stored items.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.13<\/b> The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.14<\/b> The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-3(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>25.15<\/b> The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"26._Cybersecurity\">26. Cybersecurity<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4(6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-8 and SC-8(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.1<\/b> The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9(8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13 and SC-28(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.2<\/b> The system should support database encryption and be capable of recording the encryption status of the data contained within.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.3<\/b> The system should be able to support multifactor authentication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.202\" target=\"_blank\">45 CFR Part 170.202<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (h)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.4<\/b> The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information (e.g., medical marijuana user data).<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.5<\/b> The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>26.6<\/b> The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"27._Information_privacy\">27. Information privacy<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-2 and PT-2(2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.1<\/b> The system shall comply with privacy protection compliance like that found in HIPAA provisions (e.g., when handling medical marijuana user data).<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2106\" target=\"_blank\">10 CFR Part 20.2106 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-C\" target=\"_blank\">45 CFR Part 164 Subpart C<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-2 and PT-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.2<\/b> The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.3<\/b> The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>27.4<\/b> The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.5<\/b> The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-4 and PT-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.6<\/b> The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184910\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.086 seconds\nReal time usage: 0.097 seconds\nPreprocessor visited node count: 886\/1000000\nPost\u2010expand include size: 92860\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 26.435 1 -total\n 20.88% 5.519 1 Template:LIMSpec_for_Cannabis_Testing\/Configuration_management\n 18.46% 4.879 1 Template:LIMSpec_for_Cannabis_Testing\/Data_integrity\n 17.07% 4.512 1 Template:LIMSpec_for_Cannabis_Testing\/System_validation_and_commission\n 16.62% 4.393 1 Template:LIMSpec_for_Cannabis_Testing\/System_administration\n 12.14% 3.210 1 Template:LIMSpec_for_Cannabis_Testing\/Information_privacy\n 11.77% 3.112 1 Template:LIMSpec_for_Cannabis_Testing\/Cybersecurity\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5485-0!canonical and timestamp 20230623184910 and revision id 16580. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#22._Data_integrity\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#22._Data_integrity<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","89117ffb5f5c45e6c58390fd71119767_images":[],"89117ffb5f5c45e6c58390fd71119767_timestamp":1687546823,"fd3538293b71d3994a7d99927f6c0a04_type":"article","fd3538293b71d3994a7d99927f6c0a04_title":"21. Artificial intelligence and smart systems","fd3538293b71d3994a7d99927f6c0a04_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#21._Artificial_intelligence_and_smart_systems","fd3538293b71d3994a7d99927f6c0a04_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Technology and performance improvementsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.\n\n17. Instrument data systems functions \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-12-1\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.1 The system should be able to use an application programming interface or web services to communicate with the instrument data systems common to cannabis testing, including chromatography, spectroscopy, spectrometry, and polymerase chain reaction systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.2 The system should be capable of sending samples and test orders to the instrument data systems common to cannabis testing.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-3\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\r\n\n\u25aa CLSI QMS22 2.2.2.5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.16\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n17.3 The system should be capable of receiving test results from the instrument data systems common to cannabis testing and verifying those results for completeness and readability.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-4\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.4 The system should be capable of generically parsing instrument data from the instrument data systems common to cannabis testing, in order to extract important sample details and results.\r\n \r\n\r\n \r\n\n\n\n\n18. Systems integration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 211.105 (a)\r\n\u25aa ASTM E1578-18 E-13-1\n\n18.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems, including point-of-sale systems, cultivation management systems, seed-to-sale systems, and any other state- and locally mandated industry reporting systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-2\n\n18.2 The system should accurately communicate overall system status changes to external systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa ABFT Accreditation Manual C-15\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-13-3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 3.4\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n18.3 The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.51\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa ABFT Accreditation Manual C-15\r\n\n\u25aa ASTM E1578-18 E-13-4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5\r\n\n\u25aa E.U. Annex 11-17\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa OECD GLP Principles 3.4\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n18.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-5\n\n18.5 The system should feature a reliable, effective, and supported data storage system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1110\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa ASTM E1578-18 C-6-6\r\n\n\u25aa ASTM E1578-18 E-13-6\r\n\n\u25aa CLSI QMS22 2.2.3.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\n\n\n18.6 The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-7\n\n18.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-8\n\n18.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-9\n\n18.9 The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-10\n\n18.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 21 CFR Part 820.180\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa A2LA C211 4.13.1.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.4\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-13-11\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa CLSI QMS22 2.8.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa E.U. Annex 11-7.2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, CP-9 and CP-10\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n18.11 The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-12\n\n18.12 The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-13\n\n18.13 The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-14\n\n18.14 The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-13-15\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa E.U. Annex 11-5\r\n\n\u25aa ISO 15189:2012 5.10.3\n\n\n18.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing among instruments and third-party systems like state- and locally mandated seed-to-sale systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-16\n\n18.16 The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-17\n\n18.17 The system should be able to interface with an external enterprise resource planning system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-18\n\n18.18 The system should be capable of interfacing with enterprise middleware.\r\n \r\n\r\n \r\n\n\n\n\n19. Laboratory scheduling and capacity planning \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 211.25 (c)\r\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B2\r\n\u25aa ASTM E1578-18 E-14-1\n\n19.1 The system should be able to accurately gauge and report test-based work capacity or throughput.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-14-2\n\n19.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-14-3\n\n19.3 The system should provide a means for tasks to be scheduled and allocated against available resources.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1274 (d)\n\n19.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of mycotoxin analyses or hours worked on them.\r\n \r\n\r\n \r\n\n\n\n\n20. Lean laboratory and continuous improvement \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-15-1\n\n20.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-15-2\r\n\u25aa FDA Hazard Analysis Critical Control Point Principle 1\n\n20.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.42 (b)\r\n\u25aa ASTM E1578-18 E-15-3\r\n\u25aa FDA Hazard Analysis Critical Control Point Principle 1\n\n20.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.\r\n \r\n\r\n \r\n\n\n\n\n21. Artificial intelligence and smart systems \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-16-1\n\n21.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-2\n\n21.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-3\n\n21.3 The system should support voice data capture and retrieval as smart laboratory assistance functions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-4\n\n21.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-5\r\n\u25aa NIST 800-53, Rev. 4, MA-6(2)\n\n21.5 The system should support predictive maintenance routines for laboratory instruments and equipment.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-6\n\n21.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-7\n\n21.7 The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-16-8\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)\n\n\n21.8 The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 211.28\r\n\n\u25aa 21 CFR Part 211.46\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 21 CFR Part 312.69\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa A2LA C211 5.3.4\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa A2LA C223 5.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1\r\n\n\u25aa ASTM E1492-11 4.1.8\r\n\n\u25aa ASTM E1492-11 4.4.2\r\n\n\u25aa ASTM E1578-18 E-16-9\r\n\n\u25aa CJIS Security Policy 5.9.1.6\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.4\r\n\n\u25aa ISO\/TS 22002-1:2009, 18.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.15\r\n\n\u25aa NIST 800-53, Rev. 5, MP-2\r\n\n\u25aa NIST 800-53, Rev. 5, PE-6(1)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18\n\n\n21.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1252\r\n\u25aa ASTM E1578-18 E-16-10\r\n\u25aa ISO 15189:2012 5.10.3\n\n21.10 The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 820.70 (c)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1252\r\n\n\u25aa 42 CFR Part 493.1278\r\n\n\u25aa A2LA C211 5.3\r\n\n\u25aa A2LA C223 5.3\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\n\u25aa ABFT Accreditation Manual Sec. E-22\r\n\n\u25aa ASTM E1578-18 E-16-11\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa ISO 15189:2012 5.2.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.4\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16\n\n\n21.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#21._Artificial_intelligence_and_smart_systems\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#21._Artificial_intelligence_and_smart_systems<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 21 January 2021, at 21:11.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","fd3538293b71d3994a7d99927f6c0a04_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Technology_and_performance_improvements rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Technology_and_performance_improvements skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Technology and performance improvements<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"17._Instrument_data_systems_functions\">17. Instrument data systems functions<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.1<\/b> The system should be able to use an application programming interface or web services to communicate with the instrument data systems common to cannabis testing, including chromatography, spectroscopy, spectrometry, and polymerase chain reaction systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.2<\/b> The system should be capable of sending samples and test orders to the instrument data systems common to cannabis testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.3<\/b> The system should be capable of receiving test results from the instrument data systems common to cannabis testing and verifying those results for completeness and readability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.4<\/b> The system should be capable of generically parsing instrument data from the instrument data systems common to cannabis testing, in order to extract important sample details and results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"18._Systems_integration\">18. Systems integration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.1<\/b> The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems, including point-of-sale systems, cultivation management systems, seed-to-sale systems, and any other state- and locally mandated industry reporting systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.2<\/b> The system should accurately communicate overall system status changes to external systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.3<\/b> The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.51\" target=\"_blank\">21 CFR Part 58.51<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.4<\/b> The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.5<\/b> The system should feature a reliable, effective, and supported data storage system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.6<\/b> The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.7<\/b> The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.8<\/b> The system should provide the ability to modify the data structures of the data storage mechanism as needed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-9<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.9<\/b> The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.10<\/b> The system shall provide data storage tools capable of fine-tuning the performance and security of data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9 and CP-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.11<\/b> The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.12<\/b> The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.13<\/b> The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.14<\/b> The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.15<\/b> The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing among instruments and third-party systems like state- and locally mandated seed-to-sale systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-16<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.16<\/b> The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-17<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.17<\/b> The system should be able to interface with an external enterprise resource planning system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-18<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.18<\/b> The system should be capable of interfacing with enterprise middleware.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"19._Laboratory_scheduling_and_capacity_planning\">19. Laboratory scheduling and capacity planning<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25 (c)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.1<\/b> The system should be able to accurately gauge and report test-based work capacity or throughput.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.2<\/b> The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.3<\/b> The system should provide a means for tasks to be scheduled and allocated against available resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.4<\/b> The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of mycotoxin analyses or hours worked on them.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"20._Lean_laboratory_and_continuous_improvement\">20. Lean laboratory and continuous improvement<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:150px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.1<\/b> The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.2<\/b> The system should provide a means to quickly visualize and assess workflow processes at strategic points.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.42\" target=\"_blank\">21 CFR Part 211.42 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.3<\/b> The system should provide a means for mapping everyday workflow while identifying potential failure points.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"21._Artificial_intelligence_and_smart_systems\">21. Artificial intelligence and smart systems<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.1<\/b> The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.2<\/b> The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.3<\/b> The system should support voice data capture and retrieval as smart laboratory assistance functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.4<\/b> The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, MA-6(2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.5<\/b> The system should support predictive maintenance routines for laboratory instruments and equipment.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.6<\/b> The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.7<\/b> The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.8<\/b> The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.28\" target=\"_blank\">21 CFR Part 211.28<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.46\" target=\"_blank\">21 CFR Part 211.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.69\" target=\"_blank\">21 CFR Part 312.69<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.9.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 18.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.9<\/b> The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-10<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.10<\/b> The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1278\" target=\"_blank\">42 CFR Part 493.1278<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.11<\/b> The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184909\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.042 seconds\nReal time usage: 0.048 seconds\nPreprocessor visited node count: 383\/1000000\nPost\u2010expand include size: 37905\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 16.156 1 -total\n 22.18% 3.584 1 Template:LIMSpec_for_Cannabis_Testing\/Artificial_intelligence_and_smart_systems\n 21.62% 3.493 1 Template:LIMSpec_for_Cannabis_Testing\/Systems_integration\n 21.21% 3.427 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_systems_functions\n 15.90% 2.568 1 Template:LIMSpec_for_Cannabis_Testing\/Laboratory_scheduling_and_capacity_planning\n 15.42% 2.491 1 Template:LIMSpec_for_Cannabis_Testing\/Lean_laboratory_and_continuous_improvement\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5479-0!canonical and timestamp 20230623184909 and revision id 16574. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#21._Artificial_intelligence_and_smart_systems\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#21._Artificial_intelligence_and_smart_systems<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","fd3538293b71d3994a7d99927f6c0a04_images":[],"fd3538293b71d3994a7d99927f6c0a04_timestamp":1687546823,"e7ea869e8c2900bdd9be37f28a15a11b_type":"article","e7ea869e8c2900bdd9be37f28a15a11b_title":"20. Lean laboratory and continuous improvement","e7ea869e8c2900bdd9be37f28a15a11b_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#20._Lean_laboratory_and_continuous_improvement","e7ea869e8c2900bdd9be37f28a15a11b_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Technology and performance improvementsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.\n\n17. Instrument data systems functions \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-12-1\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.1 The system should be able to use an application programming interface or web services to communicate with the instrument data systems common to cannabis testing, including chromatography, spectroscopy, spectrometry, and polymerase chain reaction systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.2 The system should be capable of sending samples and test orders to the instrument data systems common to cannabis testing.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-3\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\r\n\n\u25aa CLSI QMS22 2.2.2.5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.16\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n17.3 The system should be capable of receiving test results from the instrument data systems common to cannabis testing and verifying those results for completeness and readability.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-4\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.4 The system should be capable of generically parsing instrument data from the instrument data systems common to cannabis testing, in order to extract important sample details and results.\r\n \r\n\r\n \r\n\n\n\n\n18. Systems integration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 211.105 (a)\r\n\u25aa ASTM E1578-18 E-13-1\n\n18.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems, including point-of-sale systems, cultivation management systems, seed-to-sale systems, and any other state- and locally mandated industry reporting systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-2\n\n18.2 The system should accurately communicate overall system status changes to external systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa ABFT Accreditation Manual C-15\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-13-3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 3.4\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n18.3 The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.51\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa ABFT Accreditation Manual C-15\r\n\n\u25aa ASTM E1578-18 E-13-4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5\r\n\n\u25aa E.U. Annex 11-17\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa OECD GLP Principles 3.4\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n18.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-5\n\n18.5 The system should feature a reliable, effective, and supported data storage system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1110\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa ASTM E1578-18 C-6-6\r\n\n\u25aa ASTM E1578-18 E-13-6\r\n\n\u25aa CLSI QMS22 2.2.3.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\n\n\n18.6 The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-7\n\n18.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-8\n\n18.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-9\n\n18.9 The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-10\n\n18.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 21 CFR Part 820.180\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa A2LA C211 4.13.1.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.4\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-13-11\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa CLSI QMS22 2.8.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa E.U. Annex 11-7.2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, CP-9 and CP-10\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n18.11 The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-12\n\n18.12 The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-13\n\n18.13 The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-14\n\n18.14 The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-13-15\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa E.U. Annex 11-5\r\n\n\u25aa ISO 15189:2012 5.10.3\n\n\n18.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing among instruments and third-party systems like state- and locally mandated seed-to-sale systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-16\n\n18.16 The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-17\n\n18.17 The system should be able to interface with an external enterprise resource planning system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-18\n\n18.18 The system should be capable of interfacing with enterprise middleware.\r\n \r\n\r\n \r\n\n\n\n\n19. Laboratory scheduling and capacity planning \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 211.25 (c)\r\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B2\r\n\u25aa ASTM E1578-18 E-14-1\n\n19.1 The system should be able to accurately gauge and report test-based work capacity or throughput.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-14-2\n\n19.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-14-3\n\n19.3 The system should provide a means for tasks to be scheduled and allocated against available resources.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1274 (d)\n\n19.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of mycotoxin analyses or hours worked on them.\r\n \r\n\r\n \r\n\n\n\n\n20. Lean laboratory and continuous improvement \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-15-1\n\n20.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-15-2\r\n\u25aa FDA Hazard Analysis Critical Control Point Principle 1\n\n20.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.42 (b)\r\n\u25aa ASTM E1578-18 E-15-3\r\n\u25aa FDA Hazard Analysis Critical Control Point Principle 1\n\n20.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.\r\n \r\n\r\n \r\n\n\n\n\n21. Artificial intelligence and smart systems \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-16-1\n\n21.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-2\n\n21.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-3\n\n21.3 The system should support voice data capture and retrieval as smart laboratory assistance functions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-4\n\n21.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-5\r\n\u25aa NIST 800-53, Rev. 4, MA-6(2)\n\n21.5 The system should support predictive maintenance routines for laboratory instruments and equipment.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-6\n\n21.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-7\n\n21.7 The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-16-8\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)\n\n\n21.8 The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 211.28\r\n\n\u25aa 21 CFR Part 211.46\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 21 CFR Part 312.69\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa A2LA C211 5.3.4\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa A2LA C223 5.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1\r\n\n\u25aa ASTM E1492-11 4.1.8\r\n\n\u25aa ASTM E1492-11 4.4.2\r\n\n\u25aa ASTM E1578-18 E-16-9\r\n\n\u25aa CJIS Security Policy 5.9.1.6\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.4\r\n\n\u25aa ISO\/TS 22002-1:2009, 18.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.15\r\n\n\u25aa NIST 800-53, Rev. 5, MP-2\r\n\n\u25aa NIST 800-53, Rev. 5, PE-6(1)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18\n\n\n21.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1252\r\n\u25aa ASTM E1578-18 E-16-10\r\n\u25aa ISO 15189:2012 5.10.3\n\n21.10 The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 820.70 (c)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1252\r\n\n\u25aa 42 CFR Part 493.1278\r\n\n\u25aa A2LA C211 5.3\r\n\n\u25aa A2LA C223 5.3\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\n\u25aa ABFT Accreditation Manual Sec. E-22\r\n\n\u25aa ASTM E1578-18 E-16-11\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa ISO 15189:2012 5.2.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.4\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16\n\n\n21.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#20._Lean_laboratory_and_continuous_improvement\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#20._Lean_laboratory_and_continuous_improvement<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 21 January 2021, at 21:11.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","e7ea869e8c2900bdd9be37f28a15a11b_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Technology_and_performance_improvements rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Technology_and_performance_improvements skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Technology and performance improvements<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"17._Instrument_data_systems_functions\">17. Instrument data systems functions<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.1<\/b> The system should be able to use an application programming interface or web services to communicate with the instrument data systems common to cannabis testing, including chromatography, spectroscopy, spectrometry, and polymerase chain reaction systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.2<\/b> The system should be capable of sending samples and test orders to the instrument data systems common to cannabis testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.3<\/b> The system should be capable of receiving test results from the instrument data systems common to cannabis testing and verifying those results for completeness and readability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.4<\/b> The system should be capable of generically parsing instrument data from the instrument data systems common to cannabis testing, in order to extract important sample details and results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"18._Systems_integration\">18. Systems integration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.1<\/b> The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems, including point-of-sale systems, cultivation management systems, seed-to-sale systems, and any other state- and locally mandated industry reporting systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.2<\/b> The system should accurately communicate overall system status changes to external systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.3<\/b> The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.51\" target=\"_blank\">21 CFR Part 58.51<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.4<\/b> The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.5<\/b> The system should feature a reliable, effective, and supported data storage system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.6<\/b> The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.7<\/b> The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.8<\/b> The system should provide the ability to modify the data structures of the data storage mechanism as needed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-9<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.9<\/b> The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.10<\/b> The system shall provide data storage tools capable of fine-tuning the performance and security of data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9 and CP-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.11<\/b> The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.12<\/b> The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.13<\/b> The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.14<\/b> The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.15<\/b> The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing among instruments and third-party systems like state- and locally mandated seed-to-sale systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-16<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.16<\/b> The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-17<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.17<\/b> The system should be able to interface with an external enterprise resource planning system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-18<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.18<\/b> The system should be capable of interfacing with enterprise middleware.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"19._Laboratory_scheduling_and_capacity_planning\">19. Laboratory scheduling and capacity planning<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25 (c)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.1<\/b> The system should be able to accurately gauge and report test-based work capacity or throughput.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.2<\/b> The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.3<\/b> The system should provide a means for tasks to be scheduled and allocated against available resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.4<\/b> The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of mycotoxin analyses or hours worked on them.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"20._Lean_laboratory_and_continuous_improvement\">20. Lean laboratory and continuous improvement<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:150px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.1<\/b> The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.2<\/b> The system should provide a means to quickly visualize and assess workflow processes at strategic points.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.42\" target=\"_blank\">21 CFR Part 211.42 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.3<\/b> The system should provide a means for mapping everyday workflow while identifying potential failure points.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"21._Artificial_intelligence_and_smart_systems\">21. Artificial intelligence and smart systems<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.1<\/b> The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.2<\/b> The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.3<\/b> The system should support voice data capture and retrieval as smart laboratory assistance functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.4<\/b> The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, MA-6(2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.5<\/b> The system should support predictive maintenance routines for laboratory instruments and equipment.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.6<\/b> The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.7<\/b> The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.8<\/b> The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.28\" target=\"_blank\">21 CFR Part 211.28<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.46\" target=\"_blank\">21 CFR Part 211.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.69\" target=\"_blank\">21 CFR Part 312.69<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.9.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 18.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.9<\/b> The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-10<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.10<\/b> The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1278\" target=\"_blank\">42 CFR Part 493.1278<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.11<\/b> The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184909\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.042 seconds\nReal time usage: 0.048 seconds\nPreprocessor visited node count: 383\/1000000\nPost\u2010expand include size: 37905\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 16.156 1 -total\n 22.18% 3.584 1 Template:LIMSpec_for_Cannabis_Testing\/Artificial_intelligence_and_smart_systems\n 21.62% 3.493 1 Template:LIMSpec_for_Cannabis_Testing\/Systems_integration\n 21.21% 3.427 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_systems_functions\n 15.90% 2.568 1 Template:LIMSpec_for_Cannabis_Testing\/Laboratory_scheduling_and_capacity_planning\n 15.42% 2.491 1 Template:LIMSpec_for_Cannabis_Testing\/Lean_laboratory_and_continuous_improvement\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5479-0!canonical and timestamp 20230623184909 and revision id 16574. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#20._Lean_laboratory_and_continuous_improvement\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#20._Lean_laboratory_and_continuous_improvement<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","e7ea869e8c2900bdd9be37f28a15a11b_images":[],"e7ea869e8c2900bdd9be37f28a15a11b_timestamp":1687546822,"79175fba0222f776a02db354e90faf02_type":"article","79175fba0222f776a02db354e90faf02_title":"19. Laboratory scheduling and capacity planning","79175fba0222f776a02db354e90faf02_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#19._Laboratory_scheduling_and_capacity_planning","79175fba0222f776a02db354e90faf02_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Technology and performance improvementsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.\n\n17. Instrument data systems functions \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-12-1\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.1 The system should be able to use an application programming interface or web services to communicate with the instrument data systems common to cannabis testing, including chromatography, spectroscopy, spectrometry, and polymerase chain reaction systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.2 The system should be capable of sending samples and test orders to the instrument data systems common to cannabis testing.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-3\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\r\n\n\u25aa CLSI QMS22 2.2.2.5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.16\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n17.3 The system should be capable of receiving test results from the instrument data systems common to cannabis testing and verifying those results for completeness and readability.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-4\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.4 The system should be capable of generically parsing instrument data from the instrument data systems common to cannabis testing, in order to extract important sample details and results.\r\n \r\n\r\n \r\n\n\n\n\n18. Systems integration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 211.105 (a)\r\n\u25aa ASTM E1578-18 E-13-1\n\n18.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems, including point-of-sale systems, cultivation management systems, seed-to-sale systems, and any other state- and locally mandated industry reporting systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-2\n\n18.2 The system should accurately communicate overall system status changes to external systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa ABFT Accreditation Manual C-15\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-13-3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 3.4\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n18.3 The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.51\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa ABFT Accreditation Manual C-15\r\n\n\u25aa ASTM E1578-18 E-13-4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5\r\n\n\u25aa E.U. Annex 11-17\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa OECD GLP Principles 3.4\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n18.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-5\n\n18.5 The system should feature a reliable, effective, and supported data storage system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1110\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa ASTM E1578-18 C-6-6\r\n\n\u25aa ASTM E1578-18 E-13-6\r\n\n\u25aa CLSI QMS22 2.2.3.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\n\n\n18.6 The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-7\n\n18.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-8\n\n18.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-9\n\n18.9 The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-10\n\n18.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 21 CFR Part 820.180\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa A2LA C211 4.13.1.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.4\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-13-11\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa CLSI QMS22 2.8.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa E.U. Annex 11-7.2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, CP-9 and CP-10\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n18.11 The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-12\n\n18.12 The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-13\n\n18.13 The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-14\n\n18.14 The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-13-15\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa E.U. Annex 11-5\r\n\n\u25aa ISO 15189:2012 5.10.3\n\n\n18.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing among instruments and third-party systems like state- and locally mandated seed-to-sale systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-16\n\n18.16 The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-17\n\n18.17 The system should be able to interface with an external enterprise resource planning system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-18\n\n18.18 The system should be capable of interfacing with enterprise middleware.\r\n \r\n\r\n \r\n\n\n\n\n19. Laboratory scheduling and capacity planning \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 211.25 (c)\r\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B2\r\n\u25aa ASTM E1578-18 E-14-1\n\n19.1 The system should be able to accurately gauge and report test-based work capacity or throughput.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-14-2\n\n19.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-14-3\n\n19.3 The system should provide a means for tasks to be scheduled and allocated against available resources.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1274 (d)\n\n19.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of mycotoxin analyses or hours worked on them.\r\n \r\n\r\n \r\n\n\n\n\n20. Lean laboratory and continuous improvement \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-15-1\n\n20.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-15-2\r\n\u25aa FDA Hazard Analysis Critical Control Point Principle 1\n\n20.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.42 (b)\r\n\u25aa ASTM E1578-18 E-15-3\r\n\u25aa FDA Hazard Analysis Critical Control Point Principle 1\n\n20.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.\r\n \r\n\r\n \r\n\n\n\n\n21. Artificial intelligence and smart systems \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-16-1\n\n21.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-2\n\n21.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-3\n\n21.3 The system should support voice data capture and retrieval as smart laboratory assistance functions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-4\n\n21.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-5\r\n\u25aa NIST 800-53, Rev. 4, MA-6(2)\n\n21.5 The system should support predictive maintenance routines for laboratory instruments and equipment.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-6\n\n21.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-7\n\n21.7 The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-16-8\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)\n\n\n21.8 The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 211.28\r\n\n\u25aa 21 CFR Part 211.46\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 21 CFR Part 312.69\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa A2LA C211 5.3.4\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa A2LA C223 5.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1\r\n\n\u25aa ASTM E1492-11 4.1.8\r\n\n\u25aa ASTM E1492-11 4.4.2\r\n\n\u25aa ASTM E1578-18 E-16-9\r\n\n\u25aa CJIS Security Policy 5.9.1.6\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.4\r\n\n\u25aa ISO\/TS 22002-1:2009, 18.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.15\r\n\n\u25aa NIST 800-53, Rev. 5, MP-2\r\n\n\u25aa NIST 800-53, Rev. 5, PE-6(1)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18\n\n\n21.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1252\r\n\u25aa ASTM E1578-18 E-16-10\r\n\u25aa ISO 15189:2012 5.10.3\n\n21.10 The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 820.70 (c)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1252\r\n\n\u25aa 42 CFR Part 493.1278\r\n\n\u25aa A2LA C211 5.3\r\n\n\u25aa A2LA C223 5.3\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\n\u25aa ABFT Accreditation Manual Sec. E-22\r\n\n\u25aa ASTM E1578-18 E-16-11\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa ISO 15189:2012 5.2.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.4\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16\n\n\n21.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#19._Laboratory_scheduling_and_capacity_planning\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#19._Laboratory_scheduling_and_capacity_planning<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 21 January 2021, at 21:11.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","79175fba0222f776a02db354e90faf02_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Technology_and_performance_improvements rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Technology_and_performance_improvements skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Technology and performance improvements<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"17._Instrument_data_systems_functions\">17. Instrument data systems functions<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.1<\/b> The system should be able to use an application programming interface or web services to communicate with the instrument data systems common to cannabis testing, including chromatography, spectroscopy, spectrometry, and polymerase chain reaction systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.2<\/b> The system should be capable of sending samples and test orders to the instrument data systems common to cannabis testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.3<\/b> The system should be capable of receiving test results from the instrument data systems common to cannabis testing and verifying those results for completeness and readability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.4<\/b> The system should be capable of generically parsing instrument data from the instrument data systems common to cannabis testing, in order to extract important sample details and results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"18._Systems_integration\">18. Systems integration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.1<\/b> The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems, including point-of-sale systems, cultivation management systems, seed-to-sale systems, and any other state- and locally mandated industry reporting systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.2<\/b> The system should accurately communicate overall system status changes to external systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.3<\/b> The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.51\" target=\"_blank\">21 CFR Part 58.51<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.4<\/b> The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.5<\/b> The system should feature a reliable, effective, and supported data storage system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.6<\/b> The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.7<\/b> The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.8<\/b> The system should provide the ability to modify the data structures of the data storage mechanism as needed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-9<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.9<\/b> The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.10<\/b> The system shall provide data storage tools capable of fine-tuning the performance and security of data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9 and CP-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.11<\/b> The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.12<\/b> The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.13<\/b> The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.14<\/b> The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.15<\/b> The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing among instruments and third-party systems like state- and locally mandated seed-to-sale systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-16<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.16<\/b> The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-17<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.17<\/b> The system should be able to interface with an external enterprise resource planning system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-18<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.18<\/b> The system should be capable of interfacing with enterprise middleware.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"19._Laboratory_scheduling_and_capacity_planning\">19. Laboratory scheduling and capacity planning<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25 (c)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.1<\/b> The system should be able to accurately gauge and report test-based work capacity or throughput.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.2<\/b> The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.3<\/b> The system should provide a means for tasks to be scheduled and allocated against available resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.4<\/b> The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of mycotoxin analyses or hours worked on them.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"20._Lean_laboratory_and_continuous_improvement\">20. Lean laboratory and continuous improvement<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:150px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.1<\/b> The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.2<\/b> The system should provide a means to quickly visualize and assess workflow processes at strategic points.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.42\" target=\"_blank\">21 CFR Part 211.42 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.3<\/b> The system should provide a means for mapping everyday workflow while identifying potential failure points.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"21._Artificial_intelligence_and_smart_systems\">21. Artificial intelligence and smart systems<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.1<\/b> The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.2<\/b> The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.3<\/b> The system should support voice data capture and retrieval as smart laboratory assistance functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.4<\/b> The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, MA-6(2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.5<\/b> The system should support predictive maintenance routines for laboratory instruments and equipment.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.6<\/b> The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.7<\/b> The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.8<\/b> The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.28\" target=\"_blank\">21 CFR Part 211.28<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.46\" target=\"_blank\">21 CFR Part 211.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.69\" target=\"_blank\">21 CFR Part 312.69<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.9.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 18.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.9<\/b> The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-10<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.10<\/b> The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1278\" target=\"_blank\">42 CFR Part 493.1278<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.11<\/b> The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184909\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.042 seconds\nReal time usage: 0.048 seconds\nPreprocessor visited node count: 383\/1000000\nPost\u2010expand include size: 37905\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 16.156 1 -total\n 22.18% 3.584 1 Template:LIMSpec_for_Cannabis_Testing\/Artificial_intelligence_and_smart_systems\n 21.62% 3.493 1 Template:LIMSpec_for_Cannabis_Testing\/Systems_integration\n 21.21% 3.427 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_systems_functions\n 15.90% 2.568 1 Template:LIMSpec_for_Cannabis_Testing\/Laboratory_scheduling_and_capacity_planning\n 15.42% 2.491 1 Template:LIMSpec_for_Cannabis_Testing\/Lean_laboratory_and_continuous_improvement\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5479-0!canonical and timestamp 20230623184909 and revision id 16574. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#19._Laboratory_scheduling_and_capacity_planning\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#19._Laboratory_scheduling_and_capacity_planning<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","79175fba0222f776a02db354e90faf02_images":[],"79175fba0222f776a02db354e90faf02_timestamp":1687546822,"29ba7833bcdbcad96b34ffbfce7cbc23_type":"article","29ba7833bcdbcad96b34ffbfce7cbc23_title":"18. Systems integration","29ba7833bcdbcad96b34ffbfce7cbc23_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#18._Systems_integration","29ba7833bcdbcad96b34ffbfce7cbc23_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Technology and performance improvementsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.\n\n17. Instrument data systems functions \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-12-1\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.1 The system should be able to use an application programming interface or web services to communicate with the instrument data systems common to cannabis testing, including chromatography, spectroscopy, spectrometry, and polymerase chain reaction systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.2 The system should be capable of sending samples and test orders to the instrument data systems common to cannabis testing.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-3\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\r\n\n\u25aa CLSI QMS22 2.2.2.5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.16\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n17.3 The system should be capable of receiving test results from the instrument data systems common to cannabis testing and verifying those results for completeness and readability.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-4\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.4 The system should be capable of generically parsing instrument data from the instrument data systems common to cannabis testing, in order to extract important sample details and results.\r\n \r\n\r\n \r\n\n\n\n\n18. Systems integration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 211.105 (a)\r\n\u25aa ASTM E1578-18 E-13-1\n\n18.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems, including point-of-sale systems, cultivation management systems, seed-to-sale systems, and any other state- and locally mandated industry reporting systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-2\n\n18.2 The system should accurately communicate overall system status changes to external systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa ABFT Accreditation Manual C-15\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-13-3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 3.4\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n18.3 The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.51\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa ABFT Accreditation Manual C-15\r\n\n\u25aa ASTM E1578-18 E-13-4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5\r\n\n\u25aa E.U. Annex 11-17\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa OECD GLP Principles 3.4\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n18.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-5\n\n18.5 The system should feature a reliable, effective, and supported data storage system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1110\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa ASTM E1578-18 C-6-6\r\n\n\u25aa ASTM E1578-18 E-13-6\r\n\n\u25aa CLSI QMS22 2.2.3.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\n\n\n18.6 The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-7\n\n18.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-8\n\n18.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-9\n\n18.9 The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-10\n\n18.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 21 CFR Part 820.180\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa A2LA C211 4.13.1.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.4\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-13-11\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa CLSI QMS22 2.8.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa E.U. Annex 11-7.2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, CP-9 and CP-10\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n18.11 The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-12\n\n18.12 The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-13\n\n18.13 The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-14\n\n18.14 The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-13-15\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa E.U. Annex 11-5\r\n\n\u25aa ISO 15189:2012 5.10.3\n\n\n18.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing among instruments and third-party systems like state- and locally mandated seed-to-sale systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-16\n\n18.16 The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-17\n\n18.17 The system should be able to interface with an external enterprise resource planning system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-18\n\n18.18 The system should be capable of interfacing with enterprise middleware.\r\n \r\n\r\n \r\n\n\n\n\n19. Laboratory scheduling and capacity planning \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 211.25 (c)\r\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B2\r\n\u25aa ASTM E1578-18 E-14-1\n\n19.1 The system should be able to accurately gauge and report test-based work capacity or throughput.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-14-2\n\n19.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-14-3\n\n19.3 The system should provide a means for tasks to be scheduled and allocated against available resources.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1274 (d)\n\n19.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of mycotoxin analyses or hours worked on them.\r\n \r\n\r\n \r\n\n\n\n\n20. Lean laboratory and continuous improvement \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-15-1\n\n20.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-15-2\r\n\u25aa FDA Hazard Analysis Critical Control Point Principle 1\n\n20.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.42 (b)\r\n\u25aa ASTM E1578-18 E-15-3\r\n\u25aa FDA Hazard Analysis Critical Control Point Principle 1\n\n20.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.\r\n \r\n\r\n \r\n\n\n\n\n21. Artificial intelligence and smart systems \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-16-1\n\n21.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-2\n\n21.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-3\n\n21.3 The system should support voice data capture and retrieval as smart laboratory assistance functions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-4\n\n21.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-5\r\n\u25aa NIST 800-53, Rev. 4, MA-6(2)\n\n21.5 The system should support predictive maintenance routines for laboratory instruments and equipment.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-6\n\n21.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-7\n\n21.7 The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-16-8\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)\n\n\n21.8 The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 211.28\r\n\n\u25aa 21 CFR Part 211.46\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 21 CFR Part 312.69\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa A2LA C211 5.3.4\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa A2LA C223 5.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1\r\n\n\u25aa ASTM E1492-11 4.1.8\r\n\n\u25aa ASTM E1492-11 4.4.2\r\n\n\u25aa ASTM E1578-18 E-16-9\r\n\n\u25aa CJIS Security Policy 5.9.1.6\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.4\r\n\n\u25aa ISO\/TS 22002-1:2009, 18.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.15\r\n\n\u25aa NIST 800-53, Rev. 5, MP-2\r\n\n\u25aa NIST 800-53, Rev. 5, PE-6(1)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18\n\n\n21.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1252\r\n\u25aa ASTM E1578-18 E-16-10\r\n\u25aa ISO 15189:2012 5.10.3\n\n21.10 The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 820.70 (c)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1252\r\n\n\u25aa 42 CFR Part 493.1278\r\n\n\u25aa A2LA C211 5.3\r\n\n\u25aa A2LA C223 5.3\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\n\u25aa ABFT Accreditation Manual Sec. E-22\r\n\n\u25aa ASTM E1578-18 E-16-11\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa ISO 15189:2012 5.2.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.4\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16\n\n\n21.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#18._Systems_integration\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#18._Systems_integration<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 21 January 2021, at 21:11.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","29ba7833bcdbcad96b34ffbfce7cbc23_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Technology_and_performance_improvements rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Technology_and_performance_improvements skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Technology and performance improvements<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"17._Instrument_data_systems_functions\">17. Instrument data systems functions<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.1<\/b> The system should be able to use an application programming interface or web services to communicate with the instrument data systems common to cannabis testing, including chromatography, spectroscopy, spectrometry, and polymerase chain reaction systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.2<\/b> The system should be capable of sending samples and test orders to the instrument data systems common to cannabis testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.3<\/b> The system should be capable of receiving test results from the instrument data systems common to cannabis testing and verifying those results for completeness and readability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.4<\/b> The system should be capable of generically parsing instrument data from the instrument data systems common to cannabis testing, in order to extract important sample details and results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"18._Systems_integration\">18. Systems integration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.1<\/b> The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems, including point-of-sale systems, cultivation management systems, seed-to-sale systems, and any other state- and locally mandated industry reporting systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.2<\/b> The system should accurately communicate overall system status changes to external systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.3<\/b> The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.51\" target=\"_blank\">21 CFR Part 58.51<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.4<\/b> The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.5<\/b> The system should feature a reliable, effective, and supported data storage system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.6<\/b> The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.7<\/b> The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.8<\/b> The system should provide the ability to modify the data structures of the data storage mechanism as needed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-9<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.9<\/b> The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.10<\/b> The system shall provide data storage tools capable of fine-tuning the performance and security of data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9 and CP-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.11<\/b> The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.12<\/b> The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.13<\/b> The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.14<\/b> The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.15<\/b> The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing among instruments and third-party systems like state- and locally mandated seed-to-sale systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-16<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.16<\/b> The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-17<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.17<\/b> The system should be able to interface with an external enterprise resource planning system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-18<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.18<\/b> The system should be capable of interfacing with enterprise middleware.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"19._Laboratory_scheduling_and_capacity_planning\">19. Laboratory scheduling and capacity planning<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25 (c)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.1<\/b> The system should be able to accurately gauge and report test-based work capacity or throughput.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.2<\/b> The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.3<\/b> The system should provide a means for tasks to be scheduled and allocated against available resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.4<\/b> The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of mycotoxin analyses or hours worked on them.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"20._Lean_laboratory_and_continuous_improvement\">20. Lean laboratory and continuous improvement<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:150px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.1<\/b> The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.2<\/b> The system should provide a means to quickly visualize and assess workflow processes at strategic points.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.42\" target=\"_blank\">21 CFR Part 211.42 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.3<\/b> The system should provide a means for mapping everyday workflow while identifying potential failure points.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"21._Artificial_intelligence_and_smart_systems\">21. Artificial intelligence and smart systems<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.1<\/b> The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.2<\/b> The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.3<\/b> The system should support voice data capture and retrieval as smart laboratory assistance functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.4<\/b> The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, MA-6(2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.5<\/b> The system should support predictive maintenance routines for laboratory instruments and equipment.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.6<\/b> The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.7<\/b> The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.8<\/b> The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.28\" target=\"_blank\">21 CFR Part 211.28<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.46\" target=\"_blank\">21 CFR Part 211.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.69\" target=\"_blank\">21 CFR Part 312.69<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.9.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 18.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.9<\/b> The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-10<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.10<\/b> The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1278\" target=\"_blank\">42 CFR Part 493.1278<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.11<\/b> The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184909\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.042 seconds\nReal time usage: 0.048 seconds\nPreprocessor visited node count: 383\/1000000\nPost\u2010expand include size: 37905\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 16.156 1 -total\n 22.18% 3.584 1 Template:LIMSpec_for_Cannabis_Testing\/Artificial_intelligence_and_smart_systems\n 21.62% 3.493 1 Template:LIMSpec_for_Cannabis_Testing\/Systems_integration\n 21.21% 3.427 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_systems_functions\n 15.90% 2.568 1 Template:LIMSpec_for_Cannabis_Testing\/Laboratory_scheduling_and_capacity_planning\n 15.42% 2.491 1 Template:LIMSpec_for_Cannabis_Testing\/Lean_laboratory_and_continuous_improvement\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5479-0!canonical and timestamp 20230623184909 and revision id 16574. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#18._Systems_integration\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#18._Systems_integration<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","29ba7833bcdbcad96b34ffbfce7cbc23_images":[],"29ba7833bcdbcad96b34ffbfce7cbc23_timestamp":1687546822,"fab185a3238d6b91f6a4de4003c98680_type":"article","fab185a3238d6b91f6a4de4003c98680_title":"17. Instrument data systems functions","fab185a3238d6b91f6a4de4003c98680_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#17._Instrument_data_systems_functions","fab185a3238d6b91f6a4de4003c98680_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Technology and performance improvementsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.\n\n17. Instrument data systems functions \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-12-1\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.1 The system should be able to use an application programming interface or web services to communicate with the instrument data systems common to cannabis testing, including chromatography, spectroscopy, spectrometry, and polymerase chain reaction systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.2 The system should be capable of sending samples and test orders to the instrument data systems common to cannabis testing.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-3\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\r\n\n\u25aa CLSI QMS22 2.2.2.5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.16\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n17.3 The system should be capable of receiving test results from the instrument data systems common to cannabis testing and verifying those results for completeness and readability.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-12-4\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa CLSI AUTO15 2.0\n\n\n17.4 The system should be capable of generically parsing instrument data from the instrument data systems common to cannabis testing, in order to extract important sample details and results.\r\n \r\n\r\n \r\n\n\n\n\n18. Systems integration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 211.105 (a)\r\n\u25aa ASTM E1578-18 E-13-1\n\n18.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems, including point-of-sale systems, cultivation management systems, seed-to-sale systems, and any other state- and locally mandated industry reporting systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-2\n\n18.2 The system should accurately communicate overall system status changes to external systems.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa ABFT Accreditation Manual C-15\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-13-3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 3.4\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n18.3 The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 58.51\r\n\n\u25aa 21 CFR Part 58.190\r\n\n\u25aa ABFT Accreditation Manual C-15\r\n\n\u25aa ASTM E1578-18 E-13-4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5\r\n\n\u25aa E.U. Annex 11-17\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa OECD GLP Principles 3.4\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n18.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-5\n\n18.5 The system should feature a reliable, effective, and supported data storage system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1110\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa ASTM E1578-18 C-6-6\r\n\n\u25aa ASTM E1578-18 E-13-6\r\n\n\u25aa CLSI QMS22 2.2.3.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\n\n\n18.6 The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-7\n\n18.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-8\n\n18.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-9\n\n18.9 The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-10\n\n18.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (c)\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 21 CFR Part 820.180\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa A2LA C211 4.13.1.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.10.1.4\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 E-13-11\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa CLSI QMS22 2.8.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa E.U. Annex 11-7.2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 8.4.2\r\n\n\u25aa NIST 800-53, Rev. 5, CP-9 and CP-10\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n18.11 The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-12\n\n18.12 The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-13\n\n18.13 The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-14\n\n18.14 The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-13-15\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa E.U. Annex 11-5\r\n\n\u25aa ISO 15189:2012 5.10.3\n\n\n18.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing among instruments and third-party systems like state- and locally mandated seed-to-sale systems.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-16\n\n18.16 The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-17\n\n18.17 The system should be able to interface with an external enterprise resource planning system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-13-18\n\n18.18 The system should be capable of interfacing with enterprise middleware.\r\n \r\n\r\n \r\n\n\n\n\n19. Laboratory scheduling and capacity planning \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 211.25 (c)\r\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B2\r\n\u25aa ASTM E1578-18 E-14-1\n\n19.1 The system should be able to accurately gauge and report test-based work capacity or throughput.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-14-2\n\n19.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-14-3\n\n19.3 The system should provide a means for tasks to be scheduled and allocated against available resources.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1274 (d)\n\n19.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of mycotoxin analyses or hours worked on them.\r\n \r\n\r\n \r\n\n\n\n\n20. Lean laboratory and continuous improvement \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-15-1\n\n20.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-15-2\r\n\u25aa FDA Hazard Analysis Critical Control Point Principle 1\n\n20.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.42 (b)\r\n\u25aa ASTM E1578-18 E-15-3\r\n\u25aa FDA Hazard Analysis Critical Control Point Principle 1\n\n20.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.\r\n \r\n\r\n \r\n\n\n\n\n21. Artificial intelligence and smart systems \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-16-1\n\n21.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-2\n\n21.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-3\n\n21.3 The system should support voice data capture and retrieval as smart laboratory assistance functions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-4\n\n21.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-5\r\n\u25aa NIST 800-53, Rev. 4, MA-6(2)\n\n21.5 The system should support predictive maintenance routines for laboratory instruments and equipment.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-6\n\n21.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-16-7\n\n21.7 The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-16-8\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)\n\n\n21.8 The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 211.28\r\n\n\u25aa 21 CFR Part 211.46\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 21 CFR Part 312.69\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa A2LA C211 5.3.4\r\n\n\u25aa A2LA C211 5.4.7.2\r\n\n\u25aa A2LA C223 5.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1\r\n\n\u25aa ASTM E1492-11 4.1.8\r\n\n\u25aa ASTM E1492-11 4.4.2\r\n\n\u25aa ASTM E1578-18 E-16-9\r\n\n\u25aa CJIS Security Policy 5.9.1.6\r\n\n\u25aa CLSI QMS22 2.4.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.4\r\n\n\u25aa ISO\/TS 22002-1:2009, 18.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.15\r\n\n\u25aa NIST 800-53, Rev. 5, MP-2\r\n\n\u25aa NIST 800-53, Rev. 5, PE-6(1)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.1\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18\n\n\n21.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1252\r\n\u25aa ASTM E1578-18 E-16-10\r\n\u25aa ISO 15189:2012 5.10.3\n\n21.10 The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 820.70 (c)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1252\r\n\n\u25aa 42 CFR Part 493.1278\r\n\n\u25aa A2LA C211 5.3\r\n\n\u25aa A2LA C223 5.3\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\n\u25aa ABFT Accreditation Manual Sec. E-22\r\n\n\u25aa ASTM E1578-18 E-16-11\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa ISO 15189:2012 5.2.6\r\n\n\u25aa ISO 15189:2012 5.10.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.3.4\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 10\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16\n\n\n21.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#17._Instrument_data_systems_functions\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#17._Instrument_data_systems_functions<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 21 January 2021, at 21:11.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","fab185a3238d6b91f6a4de4003c98680_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Technology_and_performance_improvements rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Technology_and_performance_improvements skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Technology and performance improvements<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"17._Instrument_data_systems_functions\">17. Instrument data systems functions<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.1<\/b> The system should be able to use an application programming interface or web services to communicate with the instrument data systems common to cannabis testing, including chromatography, spectroscopy, spectrometry, and polymerase chain reaction systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.2<\/b> The system should be capable of sending samples and test orders to the instrument data systems common to cannabis testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.3<\/b> The system should be capable of receiving test results from the instrument data systems common to cannabis testing and verifying those results for completeness and readability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>17.4<\/b> The system should be capable of generically parsing instrument data from the instrument data systems common to cannabis testing, in order to extract important sample details and results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"18._Systems_integration\">18. Systems integration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.1<\/b> The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems, including point-of-sale systems, cultivation management systems, seed-to-sale systems, and any other state- and locally mandated industry reporting systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.2<\/b> The system should accurately communicate overall system status changes to external systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.3<\/b> The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.51\" target=\"_blank\">21 CFR Part 58.51<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.4<\/b> The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.5<\/b> The system should feature a reliable, effective, and supported data storage system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.6<\/b> The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.7<\/b> The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.8<\/b> The system should provide the ability to modify the data structures of the data storage mechanism as needed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-9<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.9<\/b> The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.10<\/b> The system shall provide data storage tools capable of fine-tuning the performance and security of data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9 and CP-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.11<\/b> The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.12<\/b> The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.13<\/b> The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.14<\/b> The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.15<\/b> The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing among instruments and third-party systems like state- and locally mandated seed-to-sale systems.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-16<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.16<\/b> The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-17<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.17<\/b> The system should be able to interface with an external enterprise resource planning system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-18<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>18.18<\/b> The system should be capable of interfacing with enterprise middleware.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"19._Laboratory_scheduling_and_capacity_planning\">19. Laboratory scheduling and capacity planning<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25 (c)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.1<\/b> The system should be able to accurately gauge and report test-based work capacity or throughput.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.2<\/b> The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.3<\/b> The system should provide a means for tasks to be scheduled and allocated against available resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>19.4<\/b> The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of mycotoxin analyses or hours worked on them.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"20._Lean_laboratory_and_continuous_improvement\">20. Lean laboratory and continuous improvement<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:150px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.1<\/b> The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.2<\/b> The system should provide a means to quickly visualize and assess workflow processes at strategic points.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.42\" target=\"_blank\">21 CFR Part 211.42 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-15-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>20.3<\/b> The system should provide a means for mapping everyday workflow while identifying potential failure points.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"21._Artificial_intelligence_and_smart_systems\">21. Artificial intelligence and smart systems<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.1<\/b> The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.2<\/b> The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.3<\/b> The system should support voice data capture and retrieval as smart laboratory assistance functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.4<\/b> The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, MA-6(2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.5<\/b> The system should support predictive maintenance routines for laboratory instruments and equipment.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.6<\/b> The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.7<\/b> The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.8<\/b> The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.28\" target=\"_blank\">21 CFR Part 211.28<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.46\" target=\"_blank\">21 CFR Part 211.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.69\" target=\"_blank\">21 CFR Part 312.69<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.9.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 18.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.9<\/b> The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-10<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.10<\/b> The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1278\" target=\"_blank\">42 CFR Part 493.1278<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>21.11<\/b> The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184909\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.042 seconds\nReal time usage: 0.048 seconds\nPreprocessor visited node count: 383\/1000000\nPost\u2010expand include size: 37905\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 16.156 1 -total\n 22.18% 3.584 1 Template:LIMSpec_for_Cannabis_Testing\/Artificial_intelligence_and_smart_systems\n 21.62% 3.493 1 Template:LIMSpec_for_Cannabis_Testing\/Systems_integration\n 21.21% 3.427 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_systems_functions\n 15.90% 2.568 1 Template:LIMSpec_for_Cannabis_Testing\/Laboratory_scheduling_and_capacity_planning\n 15.42% 2.491 1 Template:LIMSpec_for_Cannabis_Testing\/Lean_laboratory_and_continuous_improvement\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5479-0!canonical and timestamp 20230623184909 and revision id 16574. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#17._Instrument_data_systems_functions\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#17._Instrument_data_systems_functions<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","fab185a3238d6b91f6a4de4003c98680_images":[],"fab185a3238d6b91f6a4de4003c98680_timestamp":1687546822,"ab7fdb29588f2f1b80e4f3e12d7dd861_type":"article","ab7fdb29588f2f1b80e4f3e12d7dd861_title":"16. Investigation and quality management","ab7fdb29588f2f1b80e4f3e12d7dd861_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#16._Investigation_and_quality_management","ab7fdb29588f2f1b80e4f3e12d7dd861_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 10 CFR Part 20 (throughout)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.213\u201314\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ABFT Accreditation Manual (throughout)\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.5\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(e) and (h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (e)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.214\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 93.300\u20135\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 42 CFR Part 493.1773 (c\u2013d)\r\n\n\u25aa 45 CFR Part 160.310\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 (throughout)\r\n\n\u25aa A2LA C223 (throughout)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\n\u25aa AIHA-LAP Policies 2022 Appendix H5.8\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 (throughout)\r\n\n\u25aa ISO\/IEC 17025:2017 (throughout)\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 820.40 (a)\r\n\n\u25aa 42 CFR Part 493.1251 (e)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3\r\n\n\u25aa ASTM E1578-18 D-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.2\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 1.1152 (e)\r\n\n\u25aa 21 CFR Part 106.91 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.160\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.60 (c)\r\n\n\u25aa 21 CFR Part 226.58 (e)\r\n\n\u25aa 21 CFR Part 820.250 (b)\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 D-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 5\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa IFS Food 7, Part 2, 5.5.2\r\n\n\u25aa IFS Food 7, Part 2, 5.6.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.5.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.70 (b)\r\n\n\u25aa A2LA C211 5.4.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\n\u25aa ABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 10.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 4.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.10\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 10 CFR Part 30.34 (j-3)\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa 40 CFR Part 262.210\u201312\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C211 5.2\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\n\u25aa AIHA-LAP Policies 2022 (throughout)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\n\u25aa EPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4\r\n\u25aa ISO\/IEC 17025:2017 8.3.2\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\r\n \r\n\r\n \r\n\n\n\n\n8. Personnel and resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.120\r\n\n\u25aa 29 CFR Part 1910.134 (m)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-1)\r\n\n\u25aa 29 CFR Part 1910.1450 (j)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 7.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-3 and -4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3) and (h)\r\n\n\u25aa OSHA 1910.1450 (throughout)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.198\r\n\n\u25aa 42 CFR Part 493.1233\r\n\n\u25aa BRC GSFS, Issue 8, 3.10.1\u20132\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\n\u25aa IFS Food 7, Part 2, 5.8\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.15\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\n\u25aa ASTM E1578-18 E-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CJIS Security Policy 5.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2\u20133\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\n\u25aa ASTM E1578-18 E-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\n\u25aa ASTM E1578-18 E-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASTM E1578-18 E-1-4\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (e)\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa AIHA-LAP Policies 2022 (various parts)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n8.9 The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.\r\n \r\n\r\n \r\n\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17 \r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 C-4-7\r\n\n\u25aa ASTM E1578-18 E-2-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-2\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\n\u25aa NIST 800-53, Rev. 5, AU-2 and AU-3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3 and AU-8\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa ASTM E1578-18 E-2-5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.70\r\n\u25aa E.U. Annex 11-14\r\n\u25aa NIST 800-53, Rev. 5, AU-10\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 493.1274 (d)\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6 and AU-12\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ISO\/IEC 17025:2017\n\n9.8 The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See LIMSpec for Cannabis Testing 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)\r\n \r\n\r\n \r\n\n\n\n\u25aa NELAC Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (2016)\r\n\u25aa NYS ELAP Certification\n\n9.9 The system should support a laboratory's NELAC or ELAP compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\u25aa A2LA R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program\n\n9.10 The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa 21 CFR Part 606.60\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1252 (b-3)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C223 5.5\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-7\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 6\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\n\u25aa ASTM E1578-18 E-3-8\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa A2LA C211 5.5.7\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa ABFT Accreditation Manual Sec. E-21\r\n\n\u25aa ASTM E1578-18 E-3-9\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.3\r\n\n\u25aa ISO 15189:2012 5.3.1.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.9\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 820.72 (b-2)\r\n\n\u25aa ASTM E1578-18 E-3-10\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.72 (b-1)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.6.2.1\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\n\u25aa USDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.105 (b)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.4 and 5.5.5\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\n\u25aa ASTM E1578-18 E-3-12\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.1\r\n\n\u25aa ISO 15189:2012 5.3.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 58.63\r\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 211.182\r\n\n\u25aa 21 CFR Part 211.194 (d)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1254\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C211 5.10.4\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20 and -23\r\n\n\u25aa ABFT Accreditation Manual Sec. F-1 and I-1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-14\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\u20135\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.46\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\r\n \r\n\r\n \r\n\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.105 (a)\r\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\r\n\n\u25aa OECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 820.65\r\n\n\u25aa ASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\r\n \r\n\r\n \r\n\n\n\n\u25aa E.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\r\n \r\n\r\n \r\n\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\u25aa ASTM E1578-18 E-5-1\r\n\u25aa USDA Sampling Procedures for PDP 5.6\u20137\r\n\n\n12.1 The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 212.61 (a)\r\n\u25aa 21 CFR Part 211.166 (b)\r\n\u25aa ASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n12.6 The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.\r\n \r\n\r\n \r\n\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\r\n \r\n\r\n \r\n\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.83\r\n\n\u25aa 29 CFR Part 1910.1200 (g)\r\n\n\u25aa 29 CFR Part 1910.1450 (h)\r\n\n\u25aa 42 CFR Part 493.1252 (c)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-17\r\n\n\u25aa ASTM E1578-18 E-7-1\r\n\n\u25aa ISO 15189:2012 5.3.2.4\u20135\r\n\n\u25aa OECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.3\r\n\n\u25aa 9 CFR Part 121.3\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 42 CFR Part 73.3\u20134 (c)\r\n\n\u25aa ASTM E1578-18 E-7-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.12\r\n\n\u25aa ISO 15189:2012 5.3.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-3\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-4\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-5\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\r\n \r\n\r\n \r\n\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-8-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa ASTM E1578-18 E-8-2\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e-6)\r\n\n\u25aa 29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n\u25aa 40 CFR Part 262.206\r\n\n\u25aa ASTM E1578-18 E-8-3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1200(b)(3) and (f)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 117.420\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 820.50\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.5.1.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\n\u25aa IFS Food 7, Part 2, 4.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.4.1\r\n\n\u25aa ISO\/TS 22002-1:2009, 9.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.6.2\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.6.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.1\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.196\r\n\n\u25aa 21 CFR Part 212.90\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 29 CFR Part 1910.1450 Appendix A (I)\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-5\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.82 (b)\r\n\n\u25aa 21 CFR Part 211.84 (a)\r\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 21 CFR Part 211.142 (a)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa ASTM E1578-18 E-8-6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\u25aa ASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\r\n \r\n\r\n \r\n\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 312.62 (b)\r\n\u25aa 21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 312.57 (a)\r\n\n\u25aa 21 CFR Part 312.62 (a)\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 58.81 (a)\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.111\r\n\n\u25aa 21 CFR Part 211.192\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 606.171\r\n\n\u25aa 42 CFR Part 493.1253 (b-2)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ABFT Accreditation Manual C-16\r\n\n\u25aa ABFT Accreditation Manual F-2\r\n\n\u25aa ABFT Accreditation Manual J-3\r\n\n\u25aa ASTM E1578-18 E-9-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.7\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 7.3\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.2.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1282\r\n\u25aa ASTM E1578-18 E-9-2\r\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 9\n\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa ASTM E1578-18 E-9-3\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa CLSI QMS22 2.2.2.3\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.12\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 21 CFR Part 112.147\r\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 21 CFR Part 820.100\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.9 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.6.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, IR-5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.9\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 11.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 42 CFR Part 493.1289\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.8 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-5\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy Appendix G.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6(1)\r\n\n\u25aa NIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2 and SI-4\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\r\n \r\n\r\n \r\n\n\n\n\u25aa 9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#16._Investigation_and_quality_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#16._Investigation_and_quality_management<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 22 June 2023, at 22:47.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","ab7fdb29588f2f1b80e4f3e12d7dd861_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px; width:175px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Personnel_and_resource_management\">8. Personnel and resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.9<\/b> The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.8<\/b> The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See <i>LIMSpec for Cannabis Testing<\/i> 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nelac-institute.org\/content\/CSDP\/standards.php\" target=\"_blank\">NELAC <i>Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis<\/i> (2016)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/elap\/requirements-for-laboratory-certification-certification\" target=\"_blank\">NYS ELAP Certification<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.9<\/b> The system should support a laboratory's NELAC or ELAP compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.a2la.org\/accreditation\/cannabis-testing\" target=\"_blank\">A2LA <i>R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program<\/i><\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.10<\/b> The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a><br \/>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.6<\/b> The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184907\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.138 seconds\nReal time usage: 0.155 seconds\nPreprocessor visited node count: 1470\/1000000\nPost\u2010expand include size: 159889\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 43.878 1 -total\n 12.76% 5.597 1 Template:LIMSpec_for_Cannabis_Testing\/Document_management\n 12.17% 5.338 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_and_equipment_management\n 11.93% 5.233 1 Template:LIMSpec_for_Cannabis_Testing\/Personnel_and_resource_management\n 10.29% 4.515 1 Template:LIMSpec_for_Cannabis_Testing\/Investigation_and_quality_management\n 10.06% 4.416 1 Template:LIMSpec_for_Cannabis_Testing\/Compliance_management\n 9.37% 4.113 1 Template:LIMSpec_for_Cannabis_Testing\/Batch_and_lot_management\n 8.85% 3.885 1 Template:LIMSpec_for_Cannabis_Testing\/Inventory_management\n 7.49% 3.287 1 Template:LIMSpec_for_Cannabis_Testing\/Standard_and_reagent_management\n 6.61% 2.901 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5468-0!canonical and timestamp 20230623184906 and revision id 18333. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#16._Investigation_and_quality_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#16._Investigation_and_quality_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","ab7fdb29588f2f1b80e4f3e12d7dd861_images":[],"ab7fdb29588f2f1b80e4f3e12d7dd861_timestamp":1687546822,"0bc97d000872aaec451f3f49b4f26857_type":"article","0bc97d000872aaec451f3f49b4f26857_title":"15. Inventory management","0bc97d000872aaec451f3f49b4f26857_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#15._Inventory_management","0bc97d000872aaec451f3f49b4f26857_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 10 CFR Part 20 (throughout)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.213\u201314\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ABFT Accreditation Manual (throughout)\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.5\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(e) and (h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (e)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.214\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 93.300\u20135\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 42 CFR Part 493.1773 (c\u2013d)\r\n\n\u25aa 45 CFR Part 160.310\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 (throughout)\r\n\n\u25aa A2LA C223 (throughout)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\n\u25aa AIHA-LAP Policies 2022 Appendix H5.8\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 (throughout)\r\n\n\u25aa ISO\/IEC 17025:2017 (throughout)\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 820.40 (a)\r\n\n\u25aa 42 CFR Part 493.1251 (e)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3\r\n\n\u25aa ASTM E1578-18 D-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.2\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 1.1152 (e)\r\n\n\u25aa 21 CFR Part 106.91 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.160\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.60 (c)\r\n\n\u25aa 21 CFR Part 226.58 (e)\r\n\n\u25aa 21 CFR Part 820.250 (b)\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 D-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 5\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa IFS Food 7, Part 2, 5.5.2\r\n\n\u25aa IFS Food 7, Part 2, 5.6.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.5.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.70 (b)\r\n\n\u25aa A2LA C211 5.4.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\n\u25aa ABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 10.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 4.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.10\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 10 CFR Part 30.34 (j-3)\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa 40 CFR Part 262.210\u201312\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C211 5.2\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\n\u25aa AIHA-LAP Policies 2022 (throughout)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\n\u25aa EPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4\r\n\u25aa ISO\/IEC 17025:2017 8.3.2\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\r\n \r\n\r\n \r\n\n\n\n\n8. Personnel and resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.120\r\n\n\u25aa 29 CFR Part 1910.134 (m)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-1)\r\n\n\u25aa 29 CFR Part 1910.1450 (j)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 7.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-3 and -4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3) and (h)\r\n\n\u25aa OSHA 1910.1450 (throughout)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.198\r\n\n\u25aa 42 CFR Part 493.1233\r\n\n\u25aa BRC GSFS, Issue 8, 3.10.1\u20132\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\n\u25aa IFS Food 7, Part 2, 5.8\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.15\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\n\u25aa ASTM E1578-18 E-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CJIS Security Policy 5.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2\u20133\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\n\u25aa ASTM E1578-18 E-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\n\u25aa ASTM E1578-18 E-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASTM E1578-18 E-1-4\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (e)\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa AIHA-LAP Policies 2022 (various parts)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n8.9 The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.\r\n \r\n\r\n \r\n\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17 \r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 C-4-7\r\n\n\u25aa ASTM E1578-18 E-2-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-2\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\n\u25aa NIST 800-53, Rev. 5, AU-2 and AU-3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3 and AU-8\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa ASTM E1578-18 E-2-5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.70\r\n\u25aa E.U. Annex 11-14\r\n\u25aa NIST 800-53, Rev. 5, AU-10\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 493.1274 (d)\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6 and AU-12\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ISO\/IEC 17025:2017\n\n9.8 The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See LIMSpec for Cannabis Testing 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)\r\n \r\n\r\n \r\n\n\n\n\u25aa NELAC Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (2016)\r\n\u25aa NYS ELAP Certification\n\n9.9 The system should support a laboratory's NELAC or ELAP compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\u25aa A2LA R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program\n\n9.10 The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa 21 CFR Part 606.60\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1252 (b-3)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C223 5.5\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-7\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 6\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\n\u25aa ASTM E1578-18 E-3-8\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa A2LA C211 5.5.7\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa ABFT Accreditation Manual Sec. E-21\r\n\n\u25aa ASTM E1578-18 E-3-9\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.3\r\n\n\u25aa ISO 15189:2012 5.3.1.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.9\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 820.72 (b-2)\r\n\n\u25aa ASTM E1578-18 E-3-10\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.72 (b-1)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.6.2.1\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\n\u25aa USDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.105 (b)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.4 and 5.5.5\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\n\u25aa ASTM E1578-18 E-3-12\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.1\r\n\n\u25aa ISO 15189:2012 5.3.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 58.63\r\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 211.182\r\n\n\u25aa 21 CFR Part 211.194 (d)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1254\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C211 5.10.4\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20 and -23\r\n\n\u25aa ABFT Accreditation Manual Sec. F-1 and I-1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-14\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\u20135\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.46\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\r\n \r\n\r\n \r\n\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.105 (a)\r\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\r\n\n\u25aa OECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 820.65\r\n\n\u25aa ASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\r\n \r\n\r\n \r\n\n\n\n\u25aa E.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\r\n \r\n\r\n \r\n\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\u25aa ASTM E1578-18 E-5-1\r\n\u25aa USDA Sampling Procedures for PDP 5.6\u20137\r\n\n\n12.1 The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 212.61 (a)\r\n\u25aa 21 CFR Part 211.166 (b)\r\n\u25aa ASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n12.6 The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.\r\n \r\n\r\n \r\n\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\r\n \r\n\r\n \r\n\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.83\r\n\n\u25aa 29 CFR Part 1910.1200 (g)\r\n\n\u25aa 29 CFR Part 1910.1450 (h)\r\n\n\u25aa 42 CFR Part 493.1252 (c)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-17\r\n\n\u25aa ASTM E1578-18 E-7-1\r\n\n\u25aa ISO 15189:2012 5.3.2.4\u20135\r\n\n\u25aa OECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.3\r\n\n\u25aa 9 CFR Part 121.3\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 42 CFR Part 73.3\u20134 (c)\r\n\n\u25aa ASTM E1578-18 E-7-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.12\r\n\n\u25aa ISO 15189:2012 5.3.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-3\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-4\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-5\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\r\n \r\n\r\n \r\n\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-8-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa ASTM E1578-18 E-8-2\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e-6)\r\n\n\u25aa 29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n\u25aa 40 CFR Part 262.206\r\n\n\u25aa ASTM E1578-18 E-8-3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1200(b)(3) and (f)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 117.420\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 820.50\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.5.1.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\n\u25aa IFS Food 7, Part 2, 4.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.4.1\r\n\n\u25aa ISO\/TS 22002-1:2009, 9.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.6.2\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.6.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.1\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.196\r\n\n\u25aa 21 CFR Part 212.90\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 29 CFR Part 1910.1450 Appendix A (I)\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-5\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.82 (b)\r\n\n\u25aa 21 CFR Part 211.84 (a)\r\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 21 CFR Part 211.142 (a)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa ASTM E1578-18 E-8-6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\u25aa ASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\r\n \r\n\r\n \r\n\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 312.62 (b)\r\n\u25aa 21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 312.57 (a)\r\n\n\u25aa 21 CFR Part 312.62 (a)\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 58.81 (a)\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.111\r\n\n\u25aa 21 CFR Part 211.192\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 606.171\r\n\n\u25aa 42 CFR Part 493.1253 (b-2)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ABFT Accreditation Manual C-16\r\n\n\u25aa ABFT Accreditation Manual F-2\r\n\n\u25aa ABFT Accreditation Manual J-3\r\n\n\u25aa ASTM E1578-18 E-9-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.7\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 7.3\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.2.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1282\r\n\u25aa ASTM E1578-18 E-9-2\r\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 9\n\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa ASTM E1578-18 E-9-3\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa CLSI QMS22 2.2.2.3\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.12\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 21 CFR Part 112.147\r\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 21 CFR Part 820.100\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.9 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.6.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, IR-5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.9\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 11.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 42 CFR Part 493.1289\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.8 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-5\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy Appendix G.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6(1)\r\n\n\u25aa NIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2 and SI-4\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\r\n \r\n\r\n \r\n\n\n\n\u25aa 9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#15._Inventory_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#15._Inventory_management<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 22 June 2023, at 22:47.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","0bc97d000872aaec451f3f49b4f26857_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px; width:175px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Personnel_and_resource_management\">8. Personnel and resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.9<\/b> The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.8<\/b> The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See <i>LIMSpec for Cannabis Testing<\/i> 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nelac-institute.org\/content\/CSDP\/standards.php\" target=\"_blank\">NELAC <i>Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis<\/i> (2016)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/elap\/requirements-for-laboratory-certification-certification\" target=\"_blank\">NYS ELAP Certification<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.9<\/b> The system should support a laboratory's NELAC or ELAP compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.a2la.org\/accreditation\/cannabis-testing\" target=\"_blank\">A2LA <i>R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program<\/i><\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.10<\/b> The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a><br \/>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.6<\/b> The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184907\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.138 seconds\nReal time usage: 0.155 seconds\nPreprocessor visited node count: 1470\/1000000\nPost\u2010expand include size: 159889\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 43.878 1 -total\n 12.76% 5.597 1 Template:LIMSpec_for_Cannabis_Testing\/Document_management\n 12.17% 5.338 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_and_equipment_management\n 11.93% 5.233 1 Template:LIMSpec_for_Cannabis_Testing\/Personnel_and_resource_management\n 10.29% 4.515 1 Template:LIMSpec_for_Cannabis_Testing\/Investigation_and_quality_management\n 10.06% 4.416 1 Template:LIMSpec_for_Cannabis_Testing\/Compliance_management\n 9.37% 4.113 1 Template:LIMSpec_for_Cannabis_Testing\/Batch_and_lot_management\n 8.85% 3.885 1 Template:LIMSpec_for_Cannabis_Testing\/Inventory_management\n 7.49% 3.287 1 Template:LIMSpec_for_Cannabis_Testing\/Standard_and_reagent_management\n 6.61% 2.901 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5468-0!canonical and timestamp 20230623184906 and revision id 18333. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#15._Inventory_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#15._Inventory_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","0bc97d000872aaec451f3f49b4f26857_images":[],"0bc97d000872aaec451f3f49b4f26857_timestamp":1687546822,"7eccd67f6b726fbe47620b9bb6666fb0_type":"article","7eccd67f6b726fbe47620b9bb6666fb0_title":"14. Standard and reagent management","7eccd67f6b726fbe47620b9bb6666fb0_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#14._Standard_and_reagent_management","7eccd67f6b726fbe47620b9bb6666fb0_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 10 CFR Part 20 (throughout)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.213\u201314\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ABFT Accreditation Manual (throughout)\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.5\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(e) and (h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (e)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.214\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 93.300\u20135\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 42 CFR Part 493.1773 (c\u2013d)\r\n\n\u25aa 45 CFR Part 160.310\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 (throughout)\r\n\n\u25aa A2LA C223 (throughout)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\n\u25aa AIHA-LAP Policies 2022 Appendix H5.8\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 (throughout)\r\n\n\u25aa ISO\/IEC 17025:2017 (throughout)\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 820.40 (a)\r\n\n\u25aa 42 CFR Part 493.1251 (e)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3\r\n\n\u25aa ASTM E1578-18 D-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.2\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 1.1152 (e)\r\n\n\u25aa 21 CFR Part 106.91 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.160\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.60 (c)\r\n\n\u25aa 21 CFR Part 226.58 (e)\r\n\n\u25aa 21 CFR Part 820.250 (b)\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 D-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 5\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa IFS Food 7, Part 2, 5.5.2\r\n\n\u25aa IFS Food 7, Part 2, 5.6.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.5.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.70 (b)\r\n\n\u25aa A2LA C211 5.4.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\n\u25aa ABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 10.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 4.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.10\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 10 CFR Part 30.34 (j-3)\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa 40 CFR Part 262.210\u201312\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C211 5.2\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\n\u25aa AIHA-LAP Policies 2022 (throughout)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\n\u25aa EPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4\r\n\u25aa ISO\/IEC 17025:2017 8.3.2\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\r\n \r\n\r\n \r\n\n\n\n\n8. Personnel and resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.120\r\n\n\u25aa 29 CFR Part 1910.134 (m)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-1)\r\n\n\u25aa 29 CFR Part 1910.1450 (j)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 7.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-3 and -4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3) and (h)\r\n\n\u25aa OSHA 1910.1450 (throughout)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.198\r\n\n\u25aa 42 CFR Part 493.1233\r\n\n\u25aa BRC GSFS, Issue 8, 3.10.1\u20132\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\n\u25aa IFS Food 7, Part 2, 5.8\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.15\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\n\u25aa ASTM E1578-18 E-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CJIS Security Policy 5.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2\u20133\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\n\u25aa ASTM E1578-18 E-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\n\u25aa ASTM E1578-18 E-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASTM E1578-18 E-1-4\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (e)\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa AIHA-LAP Policies 2022 (various parts)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n8.9 The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.\r\n \r\n\r\n \r\n\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17 \r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 C-4-7\r\n\n\u25aa ASTM E1578-18 E-2-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-2\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\n\u25aa NIST 800-53, Rev. 5, AU-2 and AU-3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3 and AU-8\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa ASTM E1578-18 E-2-5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.70\r\n\u25aa E.U. Annex 11-14\r\n\u25aa NIST 800-53, Rev. 5, AU-10\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 493.1274 (d)\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6 and AU-12\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ISO\/IEC 17025:2017\n\n9.8 The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See LIMSpec for Cannabis Testing 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)\r\n \r\n\r\n \r\n\n\n\n\u25aa NELAC Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (2016)\r\n\u25aa NYS ELAP Certification\n\n9.9 The system should support a laboratory's NELAC or ELAP compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\u25aa A2LA R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program\n\n9.10 The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa 21 CFR Part 606.60\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1252 (b-3)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C223 5.5\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-7\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 6\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\n\u25aa ASTM E1578-18 E-3-8\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa A2LA C211 5.5.7\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa ABFT Accreditation Manual Sec. E-21\r\n\n\u25aa ASTM E1578-18 E-3-9\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.3\r\n\n\u25aa ISO 15189:2012 5.3.1.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.9\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 820.72 (b-2)\r\n\n\u25aa ASTM E1578-18 E-3-10\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.72 (b-1)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.6.2.1\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\n\u25aa USDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.105 (b)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.4 and 5.5.5\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\n\u25aa ASTM E1578-18 E-3-12\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.1\r\n\n\u25aa ISO 15189:2012 5.3.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 58.63\r\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 211.182\r\n\n\u25aa 21 CFR Part 211.194 (d)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1254\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C211 5.10.4\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20 and -23\r\n\n\u25aa ABFT Accreditation Manual Sec. F-1 and I-1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-14\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\u20135\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.46\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\r\n \r\n\r\n \r\n\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.105 (a)\r\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\r\n\n\u25aa OECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 820.65\r\n\n\u25aa ASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\r\n \r\n\r\n \r\n\n\n\n\u25aa E.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\r\n \r\n\r\n \r\n\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\u25aa ASTM E1578-18 E-5-1\r\n\u25aa USDA Sampling Procedures for PDP 5.6\u20137\r\n\n\n12.1 The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 212.61 (a)\r\n\u25aa 21 CFR Part 211.166 (b)\r\n\u25aa ASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n12.6 The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.\r\n \r\n\r\n \r\n\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\r\n \r\n\r\n \r\n\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.83\r\n\n\u25aa 29 CFR Part 1910.1200 (g)\r\n\n\u25aa 29 CFR Part 1910.1450 (h)\r\n\n\u25aa 42 CFR Part 493.1252 (c)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-17\r\n\n\u25aa ASTM E1578-18 E-7-1\r\n\n\u25aa ISO 15189:2012 5.3.2.4\u20135\r\n\n\u25aa OECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.3\r\n\n\u25aa 9 CFR Part 121.3\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 42 CFR Part 73.3\u20134 (c)\r\n\n\u25aa ASTM E1578-18 E-7-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.12\r\n\n\u25aa ISO 15189:2012 5.3.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-3\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-4\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-5\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\r\n \r\n\r\n \r\n\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-8-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa ASTM E1578-18 E-8-2\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e-6)\r\n\n\u25aa 29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n\u25aa 40 CFR Part 262.206\r\n\n\u25aa ASTM E1578-18 E-8-3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1200(b)(3) and (f)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 117.420\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 820.50\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.5.1.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\n\u25aa IFS Food 7, Part 2, 4.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.4.1\r\n\n\u25aa ISO\/TS 22002-1:2009, 9.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.6.2\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.6.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.1\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.196\r\n\n\u25aa 21 CFR Part 212.90\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 29 CFR Part 1910.1450 Appendix A (I)\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-5\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.82 (b)\r\n\n\u25aa 21 CFR Part 211.84 (a)\r\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 21 CFR Part 211.142 (a)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa ASTM E1578-18 E-8-6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\u25aa ASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\r\n \r\n\r\n \r\n\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 312.62 (b)\r\n\u25aa 21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 312.57 (a)\r\n\n\u25aa 21 CFR Part 312.62 (a)\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 58.81 (a)\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.111\r\n\n\u25aa 21 CFR Part 211.192\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 606.171\r\n\n\u25aa 42 CFR Part 493.1253 (b-2)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ABFT Accreditation Manual C-16\r\n\n\u25aa ABFT Accreditation Manual F-2\r\n\n\u25aa ABFT Accreditation Manual J-3\r\n\n\u25aa ASTM E1578-18 E-9-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.7\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 7.3\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.2.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1282\r\n\u25aa ASTM E1578-18 E-9-2\r\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 9\n\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa ASTM E1578-18 E-9-3\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa CLSI QMS22 2.2.2.3\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.12\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 21 CFR Part 112.147\r\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 21 CFR Part 820.100\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.9 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.6.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, IR-5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.9\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 11.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 42 CFR Part 493.1289\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.8 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-5\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy Appendix G.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6(1)\r\n\n\u25aa NIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2 and SI-4\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\r\n \r\n\r\n \r\n\n\n\n\u25aa 9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#14._Standard_and_reagent_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#14._Standard_and_reagent_management<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 22 June 2023, at 22:47.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","7eccd67f6b726fbe47620b9bb6666fb0_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px; width:175px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Personnel_and_resource_management\">8. Personnel and resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.9<\/b> The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.8<\/b> The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See <i>LIMSpec for Cannabis Testing<\/i> 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nelac-institute.org\/content\/CSDP\/standards.php\" target=\"_blank\">NELAC <i>Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis<\/i> (2016)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/elap\/requirements-for-laboratory-certification-certification\" target=\"_blank\">NYS ELAP Certification<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.9<\/b> The system should support a laboratory's NELAC or ELAP compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.a2la.org\/accreditation\/cannabis-testing\" target=\"_blank\">A2LA <i>R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program<\/i><\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.10<\/b> The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a><br \/>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.6<\/b> The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184907\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.138 seconds\nReal time usage: 0.155 seconds\nPreprocessor visited node count: 1470\/1000000\nPost\u2010expand include size: 159889\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 43.878 1 -total\n 12.76% 5.597 1 Template:LIMSpec_for_Cannabis_Testing\/Document_management\n 12.17% 5.338 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_and_equipment_management\n 11.93% 5.233 1 Template:LIMSpec_for_Cannabis_Testing\/Personnel_and_resource_management\n 10.29% 4.515 1 Template:LIMSpec_for_Cannabis_Testing\/Investigation_and_quality_management\n 10.06% 4.416 1 Template:LIMSpec_for_Cannabis_Testing\/Compliance_management\n 9.37% 4.113 1 Template:LIMSpec_for_Cannabis_Testing\/Batch_and_lot_management\n 8.85% 3.885 1 Template:LIMSpec_for_Cannabis_Testing\/Inventory_management\n 7.49% 3.287 1 Template:LIMSpec_for_Cannabis_Testing\/Standard_and_reagent_management\n 6.61% 2.901 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5468-0!canonical and timestamp 20230623184906 and revision id 18333. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#14._Standard_and_reagent_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#14._Standard_and_reagent_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","7eccd67f6b726fbe47620b9bb6666fb0_images":[],"7eccd67f6b726fbe47620b9bb6666fb0_timestamp":1687546821,"8ddfffdf1743f9bdabc3c36d66534bfe_type":"article","8ddfffdf1743f9bdabc3c36d66534bfe_title":"13. Instrument data capture and control","8ddfffdf1743f9bdabc3c36d66534bfe_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#13._Instrument_data_capture_and_control","8ddfffdf1743f9bdabc3c36d66534bfe_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 10 CFR Part 20 (throughout)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.213\u201314\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ABFT Accreditation Manual (throughout)\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.5\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(e) and (h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (e)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.214\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 93.300\u20135\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 42 CFR Part 493.1773 (c\u2013d)\r\n\n\u25aa 45 CFR Part 160.310\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 (throughout)\r\n\n\u25aa A2LA C223 (throughout)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\n\u25aa AIHA-LAP Policies 2022 Appendix H5.8\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 (throughout)\r\n\n\u25aa ISO\/IEC 17025:2017 (throughout)\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 820.40 (a)\r\n\n\u25aa 42 CFR Part 493.1251 (e)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3\r\n\n\u25aa ASTM E1578-18 D-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.2\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 1.1152 (e)\r\n\n\u25aa 21 CFR Part 106.91 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.160\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.60 (c)\r\n\n\u25aa 21 CFR Part 226.58 (e)\r\n\n\u25aa 21 CFR Part 820.250 (b)\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 D-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 5\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa IFS Food 7, Part 2, 5.5.2\r\n\n\u25aa IFS Food 7, Part 2, 5.6.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.5.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.70 (b)\r\n\n\u25aa A2LA C211 5.4.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\n\u25aa ABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 10.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 4.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.10\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 10 CFR Part 30.34 (j-3)\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa 40 CFR Part 262.210\u201312\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C211 5.2\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\n\u25aa AIHA-LAP Policies 2022 (throughout)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\n\u25aa EPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4\r\n\u25aa ISO\/IEC 17025:2017 8.3.2\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\r\n \r\n\r\n \r\n\n\n\n\n8. Personnel and resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.120\r\n\n\u25aa 29 CFR Part 1910.134 (m)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-1)\r\n\n\u25aa 29 CFR Part 1910.1450 (j)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 7.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-3 and -4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3) and (h)\r\n\n\u25aa OSHA 1910.1450 (throughout)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.198\r\n\n\u25aa 42 CFR Part 493.1233\r\n\n\u25aa BRC GSFS, Issue 8, 3.10.1\u20132\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\n\u25aa IFS Food 7, Part 2, 5.8\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.15\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\n\u25aa ASTM E1578-18 E-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CJIS Security Policy 5.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2\u20133\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\n\u25aa ASTM E1578-18 E-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\n\u25aa ASTM E1578-18 E-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASTM E1578-18 E-1-4\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (e)\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa AIHA-LAP Policies 2022 (various parts)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n8.9 The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.\r\n \r\n\r\n \r\n\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17 \r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 C-4-7\r\n\n\u25aa ASTM E1578-18 E-2-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-2\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\n\u25aa NIST 800-53, Rev. 5, AU-2 and AU-3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3 and AU-8\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa ASTM E1578-18 E-2-5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.70\r\n\u25aa E.U. Annex 11-14\r\n\u25aa NIST 800-53, Rev. 5, AU-10\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 493.1274 (d)\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6 and AU-12\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ISO\/IEC 17025:2017\n\n9.8 The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See LIMSpec for Cannabis Testing 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)\r\n \r\n\r\n \r\n\n\n\n\u25aa NELAC Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (2016)\r\n\u25aa NYS ELAP Certification\n\n9.9 The system should support a laboratory's NELAC or ELAP compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\u25aa A2LA R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program\n\n9.10 The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa 21 CFR Part 606.60\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1252 (b-3)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C223 5.5\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-7\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 6\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\n\u25aa ASTM E1578-18 E-3-8\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa A2LA C211 5.5.7\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa ABFT Accreditation Manual Sec. E-21\r\n\n\u25aa ASTM E1578-18 E-3-9\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.3\r\n\n\u25aa ISO 15189:2012 5.3.1.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.9\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 820.72 (b-2)\r\n\n\u25aa ASTM E1578-18 E-3-10\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.72 (b-1)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.6.2.1\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\n\u25aa USDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.105 (b)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.4 and 5.5.5\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\n\u25aa ASTM E1578-18 E-3-12\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.1\r\n\n\u25aa ISO 15189:2012 5.3.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 58.63\r\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 211.182\r\n\n\u25aa 21 CFR Part 211.194 (d)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1254\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C211 5.10.4\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20 and -23\r\n\n\u25aa ABFT Accreditation Manual Sec. F-1 and I-1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-14\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\u20135\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.46\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\r\n \r\n\r\n \r\n\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.105 (a)\r\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\r\n\n\u25aa OECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 820.65\r\n\n\u25aa ASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\r\n \r\n\r\n \r\n\n\n\n\u25aa E.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\r\n \r\n\r\n \r\n\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\u25aa ASTM E1578-18 E-5-1\r\n\u25aa USDA Sampling Procedures for PDP 5.6\u20137\r\n\n\n12.1 The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 212.61 (a)\r\n\u25aa 21 CFR Part 211.166 (b)\r\n\u25aa ASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n12.6 The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.\r\n \r\n\r\n \r\n\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\r\n \r\n\r\n \r\n\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.83\r\n\n\u25aa 29 CFR Part 1910.1200 (g)\r\n\n\u25aa 29 CFR Part 1910.1450 (h)\r\n\n\u25aa 42 CFR Part 493.1252 (c)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-17\r\n\n\u25aa ASTM E1578-18 E-7-1\r\n\n\u25aa ISO 15189:2012 5.3.2.4\u20135\r\n\n\u25aa OECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.3\r\n\n\u25aa 9 CFR Part 121.3\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 42 CFR Part 73.3\u20134 (c)\r\n\n\u25aa ASTM E1578-18 E-7-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.12\r\n\n\u25aa ISO 15189:2012 5.3.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-3\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-4\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-5\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\r\n \r\n\r\n \r\n\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-8-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa ASTM E1578-18 E-8-2\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e-6)\r\n\n\u25aa 29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n\u25aa 40 CFR Part 262.206\r\n\n\u25aa ASTM E1578-18 E-8-3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1200(b)(3) and (f)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 117.420\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 820.50\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.5.1.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\n\u25aa IFS Food 7, Part 2, 4.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.4.1\r\n\n\u25aa ISO\/TS 22002-1:2009, 9.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.6.2\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.6.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.1\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.196\r\n\n\u25aa 21 CFR Part 212.90\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 29 CFR Part 1910.1450 Appendix A (I)\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-5\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.82 (b)\r\n\n\u25aa 21 CFR Part 211.84 (a)\r\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 21 CFR Part 211.142 (a)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa ASTM E1578-18 E-8-6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\u25aa ASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\r\n \r\n\r\n \r\n\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 312.62 (b)\r\n\u25aa 21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 312.57 (a)\r\n\n\u25aa 21 CFR Part 312.62 (a)\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 58.81 (a)\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.111\r\n\n\u25aa 21 CFR Part 211.192\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 606.171\r\n\n\u25aa 42 CFR Part 493.1253 (b-2)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ABFT Accreditation Manual C-16\r\n\n\u25aa ABFT Accreditation Manual F-2\r\n\n\u25aa ABFT Accreditation Manual J-3\r\n\n\u25aa ASTM E1578-18 E-9-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.7\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 7.3\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.2.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1282\r\n\u25aa ASTM E1578-18 E-9-2\r\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 9\n\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa ASTM E1578-18 E-9-3\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa CLSI QMS22 2.2.2.3\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.12\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 21 CFR Part 112.147\r\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 21 CFR Part 820.100\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.9 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.6.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, IR-5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.9\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 11.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 42 CFR Part 493.1289\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.8 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-5\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy Appendix G.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6(1)\r\n\n\u25aa NIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2 and SI-4\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\r\n \r\n\r\n \r\n\n\n\n\u25aa 9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#13._Instrument_data_capture_and_control\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#13._Instrument_data_capture_and_control<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 22 June 2023, at 22:47.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","8ddfffdf1743f9bdabc3c36d66534bfe_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px; width:175px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Personnel_and_resource_management\">8. Personnel and resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.9<\/b> The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.8<\/b> The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See <i>LIMSpec for Cannabis Testing<\/i> 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nelac-institute.org\/content\/CSDP\/standards.php\" target=\"_blank\">NELAC <i>Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis<\/i> (2016)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/elap\/requirements-for-laboratory-certification-certification\" target=\"_blank\">NYS ELAP Certification<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.9<\/b> The system should support a laboratory's NELAC or ELAP compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.a2la.org\/accreditation\/cannabis-testing\" target=\"_blank\">A2LA <i>R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program<\/i><\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.10<\/b> The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a><br \/>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.6<\/b> The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184907\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.138 seconds\nReal time usage: 0.155 seconds\nPreprocessor visited node count: 1470\/1000000\nPost\u2010expand include size: 159889\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 43.878 1 -total\n 12.76% 5.597 1 Template:LIMSpec_for_Cannabis_Testing\/Document_management\n 12.17% 5.338 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_and_equipment_management\n 11.93% 5.233 1 Template:LIMSpec_for_Cannabis_Testing\/Personnel_and_resource_management\n 10.29% 4.515 1 Template:LIMSpec_for_Cannabis_Testing\/Investigation_and_quality_management\n 10.06% 4.416 1 Template:LIMSpec_for_Cannabis_Testing\/Compliance_management\n 9.37% 4.113 1 Template:LIMSpec_for_Cannabis_Testing\/Batch_and_lot_management\n 8.85% 3.885 1 Template:LIMSpec_for_Cannabis_Testing\/Inventory_management\n 7.49% 3.287 1 Template:LIMSpec_for_Cannabis_Testing\/Standard_and_reagent_management\n 6.61% 2.901 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5468-0!canonical and timestamp 20230623184906 and revision id 18333. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#13._Instrument_data_capture_and_control\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#13._Instrument_data_capture_and_control<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","8ddfffdf1743f9bdabc3c36d66534bfe_images":[],"8ddfffdf1743f9bdabc3c36d66534bfe_timestamp":1687546821,"149c2b936a0143ca67fcd8d3e5872955_type":"article","149c2b936a0143ca67fcd8d3e5872955_title":"12. Scheduled event management","149c2b936a0143ca67fcd8d3e5872955_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#12._Scheduled_event_management","149c2b936a0143ca67fcd8d3e5872955_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 10 CFR Part 20 (throughout)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.213\u201314\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ABFT Accreditation Manual (throughout)\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.5\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(e) and (h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (e)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.214\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 93.300\u20135\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 42 CFR Part 493.1773 (c\u2013d)\r\n\n\u25aa 45 CFR Part 160.310\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 (throughout)\r\n\n\u25aa A2LA C223 (throughout)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\n\u25aa AIHA-LAP Policies 2022 Appendix H5.8\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 (throughout)\r\n\n\u25aa ISO\/IEC 17025:2017 (throughout)\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 820.40 (a)\r\n\n\u25aa 42 CFR Part 493.1251 (e)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3\r\n\n\u25aa ASTM E1578-18 D-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.2\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 1.1152 (e)\r\n\n\u25aa 21 CFR Part 106.91 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.160\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.60 (c)\r\n\n\u25aa 21 CFR Part 226.58 (e)\r\n\n\u25aa 21 CFR Part 820.250 (b)\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 D-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 5\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa IFS Food 7, Part 2, 5.5.2\r\n\n\u25aa IFS Food 7, Part 2, 5.6.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.5.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.70 (b)\r\n\n\u25aa A2LA C211 5.4.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\n\u25aa ABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 10.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 4.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.10\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 10 CFR Part 30.34 (j-3)\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa 40 CFR Part 262.210\u201312\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C211 5.2\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\n\u25aa AIHA-LAP Policies 2022 (throughout)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\n\u25aa EPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4\r\n\u25aa ISO\/IEC 17025:2017 8.3.2\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\r\n \r\n\r\n \r\n\n\n\n\n8. Personnel and resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.120\r\n\n\u25aa 29 CFR Part 1910.134 (m)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-1)\r\n\n\u25aa 29 CFR Part 1910.1450 (j)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 7.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-3 and -4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3) and (h)\r\n\n\u25aa OSHA 1910.1450 (throughout)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.198\r\n\n\u25aa 42 CFR Part 493.1233\r\n\n\u25aa BRC GSFS, Issue 8, 3.10.1\u20132\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\n\u25aa IFS Food 7, Part 2, 5.8\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.15\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\n\u25aa ASTM E1578-18 E-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CJIS Security Policy 5.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2\u20133\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\n\u25aa ASTM E1578-18 E-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\n\u25aa ASTM E1578-18 E-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASTM E1578-18 E-1-4\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (e)\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa AIHA-LAP Policies 2022 (various parts)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n8.9 The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.\r\n \r\n\r\n \r\n\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17 \r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 C-4-7\r\n\n\u25aa ASTM E1578-18 E-2-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-2\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\n\u25aa NIST 800-53, Rev. 5, AU-2 and AU-3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3 and AU-8\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa ASTM E1578-18 E-2-5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.70\r\n\u25aa E.U. Annex 11-14\r\n\u25aa NIST 800-53, Rev. 5, AU-10\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 493.1274 (d)\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6 and AU-12\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ISO\/IEC 17025:2017\n\n9.8 The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See LIMSpec for Cannabis Testing 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)\r\n \r\n\r\n \r\n\n\n\n\u25aa NELAC Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (2016)\r\n\u25aa NYS ELAP Certification\n\n9.9 The system should support a laboratory's NELAC or ELAP compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\u25aa A2LA R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program\n\n9.10 The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa 21 CFR Part 606.60\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1252 (b-3)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C223 5.5\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-7\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 6\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\n\u25aa ASTM E1578-18 E-3-8\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa A2LA C211 5.5.7\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa ABFT Accreditation Manual Sec. E-21\r\n\n\u25aa ASTM E1578-18 E-3-9\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.3\r\n\n\u25aa ISO 15189:2012 5.3.1.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.9\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 820.72 (b-2)\r\n\n\u25aa ASTM E1578-18 E-3-10\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.72 (b-1)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.6.2.1\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\n\u25aa USDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.105 (b)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.4 and 5.5.5\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\n\u25aa ASTM E1578-18 E-3-12\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.1\r\n\n\u25aa ISO 15189:2012 5.3.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 58.63\r\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 211.182\r\n\n\u25aa 21 CFR Part 211.194 (d)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1254\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C211 5.10.4\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20 and -23\r\n\n\u25aa ABFT Accreditation Manual Sec. F-1 and I-1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-14\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\u20135\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.46\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\r\n \r\n\r\n \r\n\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.105 (a)\r\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\r\n\n\u25aa OECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 820.65\r\n\n\u25aa ASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\r\n \r\n\r\n \r\n\n\n\n\u25aa E.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\r\n \r\n\r\n \r\n\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\u25aa ASTM E1578-18 E-5-1\r\n\u25aa USDA Sampling Procedures for PDP 5.6\u20137\r\n\n\n12.1 The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 212.61 (a)\r\n\u25aa 21 CFR Part 211.166 (b)\r\n\u25aa ASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n12.6 The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.\r\n \r\n\r\n \r\n\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\r\n \r\n\r\n \r\n\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.83\r\n\n\u25aa 29 CFR Part 1910.1200 (g)\r\n\n\u25aa 29 CFR Part 1910.1450 (h)\r\n\n\u25aa 42 CFR Part 493.1252 (c)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-17\r\n\n\u25aa ASTM E1578-18 E-7-1\r\n\n\u25aa ISO 15189:2012 5.3.2.4\u20135\r\n\n\u25aa OECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.3\r\n\n\u25aa 9 CFR Part 121.3\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 42 CFR Part 73.3\u20134 (c)\r\n\n\u25aa ASTM E1578-18 E-7-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.12\r\n\n\u25aa ISO 15189:2012 5.3.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-3\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-4\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-5\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\r\n \r\n\r\n \r\n\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-8-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa ASTM E1578-18 E-8-2\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e-6)\r\n\n\u25aa 29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n\u25aa 40 CFR Part 262.206\r\n\n\u25aa ASTM E1578-18 E-8-3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1200(b)(3) and (f)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 117.420\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 820.50\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.5.1.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\n\u25aa IFS Food 7, Part 2, 4.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.4.1\r\n\n\u25aa ISO\/TS 22002-1:2009, 9.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.6.2\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.6.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.1\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.196\r\n\n\u25aa 21 CFR Part 212.90\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 29 CFR Part 1910.1450 Appendix A (I)\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-5\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.82 (b)\r\n\n\u25aa 21 CFR Part 211.84 (a)\r\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 21 CFR Part 211.142 (a)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa ASTM E1578-18 E-8-6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\u25aa ASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\r\n \r\n\r\n \r\n\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 312.62 (b)\r\n\u25aa 21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 312.57 (a)\r\n\n\u25aa 21 CFR Part 312.62 (a)\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 58.81 (a)\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.111\r\n\n\u25aa 21 CFR Part 211.192\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 606.171\r\n\n\u25aa 42 CFR Part 493.1253 (b-2)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ABFT Accreditation Manual C-16\r\n\n\u25aa ABFT Accreditation Manual F-2\r\n\n\u25aa ABFT Accreditation Manual J-3\r\n\n\u25aa ASTM E1578-18 E-9-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.7\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 7.3\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.2.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1282\r\n\u25aa ASTM E1578-18 E-9-2\r\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 9\n\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa ASTM E1578-18 E-9-3\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa CLSI QMS22 2.2.2.3\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.12\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 21 CFR Part 112.147\r\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 21 CFR Part 820.100\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.9 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.6.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, IR-5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.9\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 11.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 42 CFR Part 493.1289\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.8 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-5\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy Appendix G.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6(1)\r\n\n\u25aa NIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2 and SI-4\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\r\n \r\n\r\n \r\n\n\n\n\u25aa 9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#12._Scheduled_event_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#12._Scheduled_event_management<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 22 June 2023, at 22:47.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","149c2b936a0143ca67fcd8d3e5872955_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px; width:175px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Personnel_and_resource_management\">8. Personnel and resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.9<\/b> The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.8<\/b> The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See <i>LIMSpec for Cannabis Testing<\/i> 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nelac-institute.org\/content\/CSDP\/standards.php\" target=\"_blank\">NELAC <i>Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis<\/i> (2016)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/elap\/requirements-for-laboratory-certification-certification\" target=\"_blank\">NYS ELAP Certification<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.9<\/b> The system should support a laboratory's NELAC or ELAP compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.a2la.org\/accreditation\/cannabis-testing\" target=\"_blank\">A2LA <i>R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program<\/i><\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.10<\/b> The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a><br \/>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.6<\/b> The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184907\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.138 seconds\nReal time usage: 0.155 seconds\nPreprocessor visited node count: 1470\/1000000\nPost\u2010expand include size: 159889\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 43.878 1 -total\n 12.76% 5.597 1 Template:LIMSpec_for_Cannabis_Testing\/Document_management\n 12.17% 5.338 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_and_equipment_management\n 11.93% 5.233 1 Template:LIMSpec_for_Cannabis_Testing\/Personnel_and_resource_management\n 10.29% 4.515 1 Template:LIMSpec_for_Cannabis_Testing\/Investigation_and_quality_management\n 10.06% 4.416 1 Template:LIMSpec_for_Cannabis_Testing\/Compliance_management\n 9.37% 4.113 1 Template:LIMSpec_for_Cannabis_Testing\/Batch_and_lot_management\n 8.85% 3.885 1 Template:LIMSpec_for_Cannabis_Testing\/Inventory_management\n 7.49% 3.287 1 Template:LIMSpec_for_Cannabis_Testing\/Standard_and_reagent_management\n 6.61% 2.901 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5468-0!canonical and timestamp 20230623184906 and revision id 18333. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#12._Scheduled_event_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#12._Scheduled_event_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","149c2b936a0143ca67fcd8d3e5872955_images":[],"149c2b936a0143ca67fcd8d3e5872955_timestamp":1687546821,"6f7a45aac72ee8c27901b9458e967170_type":"article","6f7a45aac72ee8c27901b9458e967170_title":"11. Batch and lot management","6f7a45aac72ee8c27901b9458e967170_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#11._Batch_and_lot_management","6f7a45aac72ee8c27901b9458e967170_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 10 CFR Part 20 (throughout)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.213\u201314\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ABFT Accreditation Manual (throughout)\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.5\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(e) and (h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (e)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.214\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 93.300\u20135\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 42 CFR Part 493.1773 (c\u2013d)\r\n\n\u25aa 45 CFR Part 160.310\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 (throughout)\r\n\n\u25aa A2LA C223 (throughout)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\n\u25aa AIHA-LAP Policies 2022 Appendix H5.8\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 (throughout)\r\n\n\u25aa ISO\/IEC 17025:2017 (throughout)\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 820.40 (a)\r\n\n\u25aa 42 CFR Part 493.1251 (e)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3\r\n\n\u25aa ASTM E1578-18 D-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.2\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 1.1152 (e)\r\n\n\u25aa 21 CFR Part 106.91 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.160\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.60 (c)\r\n\n\u25aa 21 CFR Part 226.58 (e)\r\n\n\u25aa 21 CFR Part 820.250 (b)\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 D-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 5\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa IFS Food 7, Part 2, 5.5.2\r\n\n\u25aa IFS Food 7, Part 2, 5.6.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.5.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.70 (b)\r\n\n\u25aa A2LA C211 5.4.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\n\u25aa ABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 10.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 4.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.10\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 10 CFR Part 30.34 (j-3)\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa 40 CFR Part 262.210\u201312\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C211 5.2\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\n\u25aa AIHA-LAP Policies 2022 (throughout)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\n\u25aa EPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4\r\n\u25aa ISO\/IEC 17025:2017 8.3.2\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\r\n \r\n\r\n \r\n\n\n\n\n8. Personnel and resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.120\r\n\n\u25aa 29 CFR Part 1910.134 (m)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-1)\r\n\n\u25aa 29 CFR Part 1910.1450 (j)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 7.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-3 and -4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3) and (h)\r\n\n\u25aa OSHA 1910.1450 (throughout)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.198\r\n\n\u25aa 42 CFR Part 493.1233\r\n\n\u25aa BRC GSFS, Issue 8, 3.10.1\u20132\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\n\u25aa IFS Food 7, Part 2, 5.8\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.15\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\n\u25aa ASTM E1578-18 E-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CJIS Security Policy 5.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2\u20133\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\n\u25aa ASTM E1578-18 E-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\n\u25aa ASTM E1578-18 E-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASTM E1578-18 E-1-4\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (e)\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa AIHA-LAP Policies 2022 (various parts)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n8.9 The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.\r\n \r\n\r\n \r\n\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17 \r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 C-4-7\r\n\n\u25aa ASTM E1578-18 E-2-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-2\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\n\u25aa NIST 800-53, Rev. 5, AU-2 and AU-3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3 and AU-8\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa ASTM E1578-18 E-2-5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.70\r\n\u25aa E.U. Annex 11-14\r\n\u25aa NIST 800-53, Rev. 5, AU-10\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 493.1274 (d)\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6 and AU-12\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ISO\/IEC 17025:2017\n\n9.8 The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See LIMSpec for Cannabis Testing 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)\r\n \r\n\r\n \r\n\n\n\n\u25aa NELAC Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (2016)\r\n\u25aa NYS ELAP Certification\n\n9.9 The system should support a laboratory's NELAC or ELAP compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\u25aa A2LA R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program\n\n9.10 The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa 21 CFR Part 606.60\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1252 (b-3)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C223 5.5\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-7\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 6\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\n\u25aa ASTM E1578-18 E-3-8\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa A2LA C211 5.5.7\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa ABFT Accreditation Manual Sec. E-21\r\n\n\u25aa ASTM E1578-18 E-3-9\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.3\r\n\n\u25aa ISO 15189:2012 5.3.1.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.9\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 820.72 (b-2)\r\n\n\u25aa ASTM E1578-18 E-3-10\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.72 (b-1)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.6.2.1\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\n\u25aa USDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.105 (b)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.4 and 5.5.5\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\n\u25aa ASTM E1578-18 E-3-12\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.1\r\n\n\u25aa ISO 15189:2012 5.3.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 58.63\r\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 211.182\r\n\n\u25aa 21 CFR Part 211.194 (d)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1254\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C211 5.10.4\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20 and -23\r\n\n\u25aa ABFT Accreditation Manual Sec. F-1 and I-1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-14\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\u20135\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.46\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\r\n \r\n\r\n \r\n\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.105 (a)\r\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\r\n\n\u25aa OECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 820.65\r\n\n\u25aa ASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\r\n \r\n\r\n \r\n\n\n\n\u25aa E.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\r\n \r\n\r\n \r\n\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\u25aa ASTM E1578-18 E-5-1\r\n\u25aa USDA Sampling Procedures for PDP 5.6\u20137\r\n\n\n12.1 The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 212.61 (a)\r\n\u25aa 21 CFR Part 211.166 (b)\r\n\u25aa ASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n12.6 The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.\r\n \r\n\r\n \r\n\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\r\n \r\n\r\n \r\n\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.83\r\n\n\u25aa 29 CFR Part 1910.1200 (g)\r\n\n\u25aa 29 CFR Part 1910.1450 (h)\r\n\n\u25aa 42 CFR Part 493.1252 (c)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-17\r\n\n\u25aa ASTM E1578-18 E-7-1\r\n\n\u25aa ISO 15189:2012 5.3.2.4\u20135\r\n\n\u25aa OECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.3\r\n\n\u25aa 9 CFR Part 121.3\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 42 CFR Part 73.3\u20134 (c)\r\n\n\u25aa ASTM E1578-18 E-7-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.12\r\n\n\u25aa ISO 15189:2012 5.3.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-3\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-4\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-5\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\r\n \r\n\r\n \r\n\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-8-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa ASTM E1578-18 E-8-2\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e-6)\r\n\n\u25aa 29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n\u25aa 40 CFR Part 262.206\r\n\n\u25aa ASTM E1578-18 E-8-3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1200(b)(3) and (f)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 117.420\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 820.50\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.5.1.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\n\u25aa IFS Food 7, Part 2, 4.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.4.1\r\n\n\u25aa ISO\/TS 22002-1:2009, 9.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.6.2\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.6.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.1\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.196\r\n\n\u25aa 21 CFR Part 212.90\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 29 CFR Part 1910.1450 Appendix A (I)\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-5\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.82 (b)\r\n\n\u25aa 21 CFR Part 211.84 (a)\r\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 21 CFR Part 211.142 (a)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa ASTM E1578-18 E-8-6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\u25aa ASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\r\n \r\n\r\n \r\n\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 312.62 (b)\r\n\u25aa 21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 312.57 (a)\r\n\n\u25aa 21 CFR Part 312.62 (a)\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 58.81 (a)\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.111\r\n\n\u25aa 21 CFR Part 211.192\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 606.171\r\n\n\u25aa 42 CFR Part 493.1253 (b-2)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ABFT Accreditation Manual C-16\r\n\n\u25aa ABFT Accreditation Manual F-2\r\n\n\u25aa ABFT Accreditation Manual J-3\r\n\n\u25aa ASTM E1578-18 E-9-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.7\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 7.3\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.2.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1282\r\n\u25aa ASTM E1578-18 E-9-2\r\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 9\n\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa ASTM E1578-18 E-9-3\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa CLSI QMS22 2.2.2.3\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.12\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 21 CFR Part 112.147\r\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 21 CFR Part 820.100\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.9 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.6.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, IR-5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.9\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 11.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 42 CFR Part 493.1289\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.8 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-5\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy Appendix G.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6(1)\r\n\n\u25aa NIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2 and SI-4\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\r\n \r\n\r\n \r\n\n\n\n\u25aa 9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#11._Batch_and_lot_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#11._Batch_and_lot_management<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 22 June 2023, at 22:47.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","6f7a45aac72ee8c27901b9458e967170_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px; width:175px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Personnel_and_resource_management\">8. Personnel and resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.9<\/b> The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.8<\/b> The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See <i>LIMSpec for Cannabis Testing<\/i> 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nelac-institute.org\/content\/CSDP\/standards.php\" target=\"_blank\">NELAC <i>Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis<\/i> (2016)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/elap\/requirements-for-laboratory-certification-certification\" target=\"_blank\">NYS ELAP Certification<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.9<\/b> The system should support a laboratory's NELAC or ELAP compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.a2la.org\/accreditation\/cannabis-testing\" target=\"_blank\">A2LA <i>R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program<\/i><\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.10<\/b> The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a><br \/>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.6<\/b> The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184907\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.138 seconds\nReal time usage: 0.155 seconds\nPreprocessor visited node count: 1470\/1000000\nPost\u2010expand include size: 159889\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 43.878 1 -total\n 12.76% 5.597 1 Template:LIMSpec_for_Cannabis_Testing\/Document_management\n 12.17% 5.338 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_and_equipment_management\n 11.93% 5.233 1 Template:LIMSpec_for_Cannabis_Testing\/Personnel_and_resource_management\n 10.29% 4.515 1 Template:LIMSpec_for_Cannabis_Testing\/Investigation_and_quality_management\n 10.06% 4.416 1 Template:LIMSpec_for_Cannabis_Testing\/Compliance_management\n 9.37% 4.113 1 Template:LIMSpec_for_Cannabis_Testing\/Batch_and_lot_management\n 8.85% 3.885 1 Template:LIMSpec_for_Cannabis_Testing\/Inventory_management\n 7.49% 3.287 1 Template:LIMSpec_for_Cannabis_Testing\/Standard_and_reagent_management\n 6.61% 2.901 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5468-0!canonical and timestamp 20230623184906 and revision id 18333. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#11._Batch_and_lot_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#11._Batch_and_lot_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","6f7a45aac72ee8c27901b9458e967170_images":[],"6f7a45aac72ee8c27901b9458e967170_timestamp":1687546821,"cf2bd1d95334c62bdf02eddca4788d7d_type":"article","cf2bd1d95334c62bdf02eddca4788d7d_title":"10. Instrument and equipment management","cf2bd1d95334c62bdf02eddca4788d7d_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#10._Instrument_and_equipment_management","cf2bd1d95334c62bdf02eddca4788d7d_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 10 CFR Part 20 (throughout)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.213\u201314\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ABFT Accreditation Manual (throughout)\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.5\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(e) and (h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (e)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.214\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 93.300\u20135\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 42 CFR Part 493.1773 (c\u2013d)\r\n\n\u25aa 45 CFR Part 160.310\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 (throughout)\r\n\n\u25aa A2LA C223 (throughout)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\n\u25aa AIHA-LAP Policies 2022 Appendix H5.8\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 (throughout)\r\n\n\u25aa ISO\/IEC 17025:2017 (throughout)\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 820.40 (a)\r\n\n\u25aa 42 CFR Part 493.1251 (e)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3\r\n\n\u25aa ASTM E1578-18 D-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.2\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 1.1152 (e)\r\n\n\u25aa 21 CFR Part 106.91 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.160\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.60 (c)\r\n\n\u25aa 21 CFR Part 226.58 (e)\r\n\n\u25aa 21 CFR Part 820.250 (b)\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 D-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 5\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa IFS Food 7, Part 2, 5.5.2\r\n\n\u25aa IFS Food 7, Part 2, 5.6.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.5.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.70 (b)\r\n\n\u25aa A2LA C211 5.4.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\n\u25aa ABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 10.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 4.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.10\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 10 CFR Part 30.34 (j-3)\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa 40 CFR Part 262.210\u201312\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C211 5.2\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\n\u25aa AIHA-LAP Policies 2022 (throughout)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\n\u25aa EPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4\r\n\u25aa ISO\/IEC 17025:2017 8.3.2\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\r\n \r\n\r\n \r\n\n\n\n\n8. Personnel and resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.120\r\n\n\u25aa 29 CFR Part 1910.134 (m)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-1)\r\n\n\u25aa 29 CFR Part 1910.1450 (j)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 7.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-3 and -4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3) and (h)\r\n\n\u25aa OSHA 1910.1450 (throughout)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.198\r\n\n\u25aa 42 CFR Part 493.1233\r\n\n\u25aa BRC GSFS, Issue 8, 3.10.1\u20132\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\n\u25aa IFS Food 7, Part 2, 5.8\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.15\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\n\u25aa ASTM E1578-18 E-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CJIS Security Policy 5.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2\u20133\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\n\u25aa ASTM E1578-18 E-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\n\u25aa ASTM E1578-18 E-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASTM E1578-18 E-1-4\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (e)\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa AIHA-LAP Policies 2022 (various parts)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n8.9 The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.\r\n \r\n\r\n \r\n\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17 \r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 C-4-7\r\n\n\u25aa ASTM E1578-18 E-2-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-2\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\n\u25aa NIST 800-53, Rev. 5, AU-2 and AU-3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3 and AU-8\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa ASTM E1578-18 E-2-5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.70\r\n\u25aa E.U. Annex 11-14\r\n\u25aa NIST 800-53, Rev. 5, AU-10\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 493.1274 (d)\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6 and AU-12\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ISO\/IEC 17025:2017\n\n9.8 The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See LIMSpec for Cannabis Testing 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)\r\n \r\n\r\n \r\n\n\n\n\u25aa NELAC Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (2016)\r\n\u25aa NYS ELAP Certification\n\n9.9 The system should support a laboratory's NELAC or ELAP compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\u25aa A2LA R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program\n\n9.10 The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa 21 CFR Part 606.60\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1252 (b-3)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C223 5.5\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-7\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 6\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\n\u25aa ASTM E1578-18 E-3-8\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa A2LA C211 5.5.7\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa ABFT Accreditation Manual Sec. E-21\r\n\n\u25aa ASTM E1578-18 E-3-9\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.3\r\n\n\u25aa ISO 15189:2012 5.3.1.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.9\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 820.72 (b-2)\r\n\n\u25aa ASTM E1578-18 E-3-10\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.72 (b-1)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.6.2.1\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\n\u25aa USDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.105 (b)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.4 and 5.5.5\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\n\u25aa ASTM E1578-18 E-3-12\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.1\r\n\n\u25aa ISO 15189:2012 5.3.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 58.63\r\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 211.182\r\n\n\u25aa 21 CFR Part 211.194 (d)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1254\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C211 5.10.4\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20 and -23\r\n\n\u25aa ABFT Accreditation Manual Sec. F-1 and I-1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-14\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\u20135\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.46\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\r\n \r\n\r\n \r\n\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.105 (a)\r\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\r\n\n\u25aa OECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 820.65\r\n\n\u25aa ASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\r\n \r\n\r\n \r\n\n\n\n\u25aa E.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\r\n \r\n\r\n \r\n\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\u25aa ASTM E1578-18 E-5-1\r\n\u25aa USDA Sampling Procedures for PDP 5.6\u20137\r\n\n\n12.1 The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 212.61 (a)\r\n\u25aa 21 CFR Part 211.166 (b)\r\n\u25aa ASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n12.6 The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.\r\n \r\n\r\n \r\n\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\r\n \r\n\r\n \r\n\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.83\r\n\n\u25aa 29 CFR Part 1910.1200 (g)\r\n\n\u25aa 29 CFR Part 1910.1450 (h)\r\n\n\u25aa 42 CFR Part 493.1252 (c)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-17\r\n\n\u25aa ASTM E1578-18 E-7-1\r\n\n\u25aa ISO 15189:2012 5.3.2.4\u20135\r\n\n\u25aa OECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.3\r\n\n\u25aa 9 CFR Part 121.3\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 42 CFR Part 73.3\u20134 (c)\r\n\n\u25aa ASTM E1578-18 E-7-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.12\r\n\n\u25aa ISO 15189:2012 5.3.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-3\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-4\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-5\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\r\n \r\n\r\n \r\n\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-8-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa ASTM E1578-18 E-8-2\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e-6)\r\n\n\u25aa 29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n\u25aa 40 CFR Part 262.206\r\n\n\u25aa ASTM E1578-18 E-8-3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1200(b)(3) and (f)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 117.420\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 820.50\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.5.1.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\n\u25aa IFS Food 7, Part 2, 4.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.4.1\r\n\n\u25aa ISO\/TS 22002-1:2009, 9.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.6.2\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.6.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.1\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.196\r\n\n\u25aa 21 CFR Part 212.90\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 29 CFR Part 1910.1450 Appendix A (I)\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-5\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.82 (b)\r\n\n\u25aa 21 CFR Part 211.84 (a)\r\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 21 CFR Part 211.142 (a)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa ASTM E1578-18 E-8-6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\u25aa ASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\r\n \r\n\r\n \r\n\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 312.62 (b)\r\n\u25aa 21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 312.57 (a)\r\n\n\u25aa 21 CFR Part 312.62 (a)\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 58.81 (a)\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.111\r\n\n\u25aa 21 CFR Part 211.192\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 606.171\r\n\n\u25aa 42 CFR Part 493.1253 (b-2)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ABFT Accreditation Manual C-16\r\n\n\u25aa ABFT Accreditation Manual F-2\r\n\n\u25aa ABFT Accreditation Manual J-3\r\n\n\u25aa ASTM E1578-18 E-9-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.7\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 7.3\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.2.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1282\r\n\u25aa ASTM E1578-18 E-9-2\r\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 9\n\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa ASTM E1578-18 E-9-3\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa CLSI QMS22 2.2.2.3\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.12\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 21 CFR Part 112.147\r\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 21 CFR Part 820.100\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.9 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.6.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, IR-5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.9\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 11.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 42 CFR Part 493.1289\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.8 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-5\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy Appendix G.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6(1)\r\n\n\u25aa NIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2 and SI-4\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\r\n \r\n\r\n \r\n\n\n\n\u25aa 9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#10._Instrument_and_equipment_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#10._Instrument_and_equipment_management<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 22 June 2023, at 22:47.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","cf2bd1d95334c62bdf02eddca4788d7d_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px; width:175px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Personnel_and_resource_management\">8. Personnel and resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.9<\/b> The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.8<\/b> The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See <i>LIMSpec for Cannabis Testing<\/i> 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nelac-institute.org\/content\/CSDP\/standards.php\" target=\"_blank\">NELAC <i>Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis<\/i> (2016)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/elap\/requirements-for-laboratory-certification-certification\" target=\"_blank\">NYS ELAP Certification<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.9<\/b> The system should support a laboratory's NELAC or ELAP compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.a2la.org\/accreditation\/cannabis-testing\" target=\"_blank\">A2LA <i>R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program<\/i><\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.10<\/b> The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a><br \/>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.6<\/b> The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184907\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.138 seconds\nReal time usage: 0.155 seconds\nPreprocessor visited node count: 1470\/1000000\nPost\u2010expand include size: 159889\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 43.878 1 -total\n 12.76% 5.597 1 Template:LIMSpec_for_Cannabis_Testing\/Document_management\n 12.17% 5.338 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_and_equipment_management\n 11.93% 5.233 1 Template:LIMSpec_for_Cannabis_Testing\/Personnel_and_resource_management\n 10.29% 4.515 1 Template:LIMSpec_for_Cannabis_Testing\/Investigation_and_quality_management\n 10.06% 4.416 1 Template:LIMSpec_for_Cannabis_Testing\/Compliance_management\n 9.37% 4.113 1 Template:LIMSpec_for_Cannabis_Testing\/Batch_and_lot_management\n 8.85% 3.885 1 Template:LIMSpec_for_Cannabis_Testing\/Inventory_management\n 7.49% 3.287 1 Template:LIMSpec_for_Cannabis_Testing\/Standard_and_reagent_management\n 6.61% 2.901 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5468-0!canonical and timestamp 20230623184906 and revision id 18333. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#10._Instrument_and_equipment_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#10._Instrument_and_equipment_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","cf2bd1d95334c62bdf02eddca4788d7d_images":[],"cf2bd1d95334c62bdf02eddca4788d7d_timestamp":1687546820,"643bd0275635c7b46f0a0cffc057e344_type":"article","643bd0275635c7b46f0a0cffc057e344_title":"9. Compliance management","643bd0275635c7b46f0a0cffc057e344_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#9._Compliance_management","643bd0275635c7b46f0a0cffc057e344_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 10 CFR Part 20 (throughout)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.213\u201314\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ABFT Accreditation Manual (throughout)\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.5\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(e) and (h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (e)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.214\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 93.300\u20135\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 42 CFR Part 493.1773 (c\u2013d)\r\n\n\u25aa 45 CFR Part 160.310\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 (throughout)\r\n\n\u25aa A2LA C223 (throughout)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\n\u25aa AIHA-LAP Policies 2022 Appendix H5.8\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 (throughout)\r\n\n\u25aa ISO\/IEC 17025:2017 (throughout)\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 820.40 (a)\r\n\n\u25aa 42 CFR Part 493.1251 (e)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3\r\n\n\u25aa ASTM E1578-18 D-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.2\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 1.1152 (e)\r\n\n\u25aa 21 CFR Part 106.91 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.160\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.60 (c)\r\n\n\u25aa 21 CFR Part 226.58 (e)\r\n\n\u25aa 21 CFR Part 820.250 (b)\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 D-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 5\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa IFS Food 7, Part 2, 5.5.2\r\n\n\u25aa IFS Food 7, Part 2, 5.6.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.5.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.70 (b)\r\n\n\u25aa A2LA C211 5.4.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\n\u25aa ABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 10.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 4.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.10\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 10 CFR Part 30.34 (j-3)\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa 40 CFR Part 262.210\u201312\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C211 5.2\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\n\u25aa AIHA-LAP Policies 2022 (throughout)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\n\u25aa EPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4\r\n\u25aa ISO\/IEC 17025:2017 8.3.2\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\r\n \r\n\r\n \r\n\n\n\n\n8. Personnel and resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.120\r\n\n\u25aa 29 CFR Part 1910.134 (m)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-1)\r\n\n\u25aa 29 CFR Part 1910.1450 (j)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 7.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-3 and -4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3) and (h)\r\n\n\u25aa OSHA 1910.1450 (throughout)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.198\r\n\n\u25aa 42 CFR Part 493.1233\r\n\n\u25aa BRC GSFS, Issue 8, 3.10.1\u20132\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\n\u25aa IFS Food 7, Part 2, 5.8\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.15\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\n\u25aa ASTM E1578-18 E-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CJIS Security Policy 5.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2\u20133\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\n\u25aa ASTM E1578-18 E-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\n\u25aa ASTM E1578-18 E-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASTM E1578-18 E-1-4\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (e)\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa AIHA-LAP Policies 2022 (various parts)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n8.9 The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.\r\n \r\n\r\n \r\n\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17 \r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 C-4-7\r\n\n\u25aa ASTM E1578-18 E-2-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-2\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\n\u25aa NIST 800-53, Rev. 5, AU-2 and AU-3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3 and AU-8\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa ASTM E1578-18 E-2-5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.70\r\n\u25aa E.U. Annex 11-14\r\n\u25aa NIST 800-53, Rev. 5, AU-10\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 493.1274 (d)\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6 and AU-12\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ISO\/IEC 17025:2017\n\n9.8 The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See LIMSpec for Cannabis Testing 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)\r\n \r\n\r\n \r\n\n\n\n\u25aa NELAC Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (2016)\r\n\u25aa NYS ELAP Certification\n\n9.9 The system should support a laboratory's NELAC or ELAP compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\u25aa A2LA R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program\n\n9.10 The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa 21 CFR Part 606.60\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1252 (b-3)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C223 5.5\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-7\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 6\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\n\u25aa ASTM E1578-18 E-3-8\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa A2LA C211 5.5.7\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa ABFT Accreditation Manual Sec. E-21\r\n\n\u25aa ASTM E1578-18 E-3-9\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.3\r\n\n\u25aa ISO 15189:2012 5.3.1.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.9\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 820.72 (b-2)\r\n\n\u25aa ASTM E1578-18 E-3-10\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.72 (b-1)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.6.2.1\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\n\u25aa USDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.105 (b)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.4 and 5.5.5\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\n\u25aa ASTM E1578-18 E-3-12\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.1\r\n\n\u25aa ISO 15189:2012 5.3.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 58.63\r\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 211.182\r\n\n\u25aa 21 CFR Part 211.194 (d)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1254\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C211 5.10.4\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20 and -23\r\n\n\u25aa ABFT Accreditation Manual Sec. F-1 and I-1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-14\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\u20135\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.46\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\r\n \r\n\r\n \r\n\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.105 (a)\r\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\r\n\n\u25aa OECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 820.65\r\n\n\u25aa ASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\r\n \r\n\r\n \r\n\n\n\n\u25aa E.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\r\n \r\n\r\n \r\n\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\u25aa ASTM E1578-18 E-5-1\r\n\u25aa USDA Sampling Procedures for PDP 5.6\u20137\r\n\n\n12.1 The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 212.61 (a)\r\n\u25aa 21 CFR Part 211.166 (b)\r\n\u25aa ASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n12.6 The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.\r\n \r\n\r\n \r\n\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\r\n \r\n\r\n \r\n\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.83\r\n\n\u25aa 29 CFR Part 1910.1200 (g)\r\n\n\u25aa 29 CFR Part 1910.1450 (h)\r\n\n\u25aa 42 CFR Part 493.1252 (c)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-17\r\n\n\u25aa ASTM E1578-18 E-7-1\r\n\n\u25aa ISO 15189:2012 5.3.2.4\u20135\r\n\n\u25aa OECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.3\r\n\n\u25aa 9 CFR Part 121.3\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 42 CFR Part 73.3\u20134 (c)\r\n\n\u25aa ASTM E1578-18 E-7-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.12\r\n\n\u25aa ISO 15189:2012 5.3.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-3\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-4\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-5\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\r\n \r\n\r\n \r\n\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-8-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa ASTM E1578-18 E-8-2\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e-6)\r\n\n\u25aa 29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n\u25aa 40 CFR Part 262.206\r\n\n\u25aa ASTM E1578-18 E-8-3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1200(b)(3) and (f)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 117.420\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 820.50\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.5.1.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\n\u25aa IFS Food 7, Part 2, 4.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.4.1\r\n\n\u25aa ISO\/TS 22002-1:2009, 9.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.6.2\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.6.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.1\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.196\r\n\n\u25aa 21 CFR Part 212.90\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 29 CFR Part 1910.1450 Appendix A (I)\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-5\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.82 (b)\r\n\n\u25aa 21 CFR Part 211.84 (a)\r\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 21 CFR Part 211.142 (a)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa ASTM E1578-18 E-8-6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\u25aa ASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\r\n \r\n\r\n \r\n\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 312.62 (b)\r\n\u25aa 21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 312.57 (a)\r\n\n\u25aa 21 CFR Part 312.62 (a)\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 58.81 (a)\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.111\r\n\n\u25aa 21 CFR Part 211.192\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 606.171\r\n\n\u25aa 42 CFR Part 493.1253 (b-2)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ABFT Accreditation Manual C-16\r\n\n\u25aa ABFT Accreditation Manual F-2\r\n\n\u25aa ABFT Accreditation Manual J-3\r\n\n\u25aa ASTM E1578-18 E-9-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.7\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 7.3\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.2.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1282\r\n\u25aa ASTM E1578-18 E-9-2\r\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 9\n\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa ASTM E1578-18 E-9-3\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa CLSI QMS22 2.2.2.3\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.12\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 21 CFR Part 112.147\r\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 21 CFR Part 820.100\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.9 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.6.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, IR-5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.9\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 11.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 42 CFR Part 493.1289\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.8 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-5\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy Appendix G.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6(1)\r\n\n\u25aa NIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2 and SI-4\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\r\n \r\n\r\n \r\n\n\n\n\u25aa 9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#9._Compliance_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#9._Compliance_management<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 22 June 2023, at 22:47.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","643bd0275635c7b46f0a0cffc057e344_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px; width:175px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Personnel_and_resource_management\">8. Personnel and resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.9<\/b> The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.8<\/b> The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See <i>LIMSpec for Cannabis Testing<\/i> 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nelac-institute.org\/content\/CSDP\/standards.php\" target=\"_blank\">NELAC <i>Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis<\/i> (2016)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/elap\/requirements-for-laboratory-certification-certification\" target=\"_blank\">NYS ELAP Certification<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.9<\/b> The system should support a laboratory's NELAC or ELAP compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.a2la.org\/accreditation\/cannabis-testing\" target=\"_blank\">A2LA <i>R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program<\/i><\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.10<\/b> The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a><br \/>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.6<\/b> The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184907\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.138 seconds\nReal time usage: 0.155 seconds\nPreprocessor visited node count: 1470\/1000000\nPost\u2010expand include size: 159889\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 43.878 1 -total\n 12.76% 5.597 1 Template:LIMSpec_for_Cannabis_Testing\/Document_management\n 12.17% 5.338 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_and_equipment_management\n 11.93% 5.233 1 Template:LIMSpec_for_Cannabis_Testing\/Personnel_and_resource_management\n 10.29% 4.515 1 Template:LIMSpec_for_Cannabis_Testing\/Investigation_and_quality_management\n 10.06% 4.416 1 Template:LIMSpec_for_Cannabis_Testing\/Compliance_management\n 9.37% 4.113 1 Template:LIMSpec_for_Cannabis_Testing\/Batch_and_lot_management\n 8.85% 3.885 1 Template:LIMSpec_for_Cannabis_Testing\/Inventory_management\n 7.49% 3.287 1 Template:LIMSpec_for_Cannabis_Testing\/Standard_and_reagent_management\n 6.61% 2.901 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5468-0!canonical and timestamp 20230623184906 and revision id 18333. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#9._Compliance_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#9._Compliance_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","643bd0275635c7b46f0a0cffc057e344_images":[],"643bd0275635c7b46f0a0cffc057e344_timestamp":1687546820,"e4cd57c94f774a5adcaa21560153afd3_type":"article","e4cd57c94f774a5adcaa21560153afd3_title":"8. Personnel and resource management","e4cd57c94f774a5adcaa21560153afd3_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#8._Personnel_and_resource_management","e4cd57c94f774a5adcaa21560153afd3_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 10 CFR Part 20 (throughout)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.213\u201314\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ABFT Accreditation Manual (throughout)\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.5\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(e) and (h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (e)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.214\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 93.300\u20135\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 42 CFR Part 493.1773 (c\u2013d)\r\n\n\u25aa 45 CFR Part 160.310\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 (throughout)\r\n\n\u25aa A2LA C223 (throughout)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\n\u25aa AIHA-LAP Policies 2022 Appendix H5.8\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 (throughout)\r\n\n\u25aa ISO\/IEC 17025:2017 (throughout)\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 820.40 (a)\r\n\n\u25aa 42 CFR Part 493.1251 (e)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3\r\n\n\u25aa ASTM E1578-18 D-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.2\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 1.1152 (e)\r\n\n\u25aa 21 CFR Part 106.91 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.160\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.60 (c)\r\n\n\u25aa 21 CFR Part 226.58 (e)\r\n\n\u25aa 21 CFR Part 820.250 (b)\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 D-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 5\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa IFS Food 7, Part 2, 5.5.2\r\n\n\u25aa IFS Food 7, Part 2, 5.6.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.5.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.70 (b)\r\n\n\u25aa A2LA C211 5.4.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\n\u25aa ABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 10.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 4.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.10\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 10 CFR Part 30.34 (j-3)\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa 40 CFR Part 262.210\u201312\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C211 5.2\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\n\u25aa AIHA-LAP Policies 2022 (throughout)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\n\u25aa EPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4\r\n\u25aa ISO\/IEC 17025:2017 8.3.2\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\r\n \r\n\r\n \r\n\n\n\n\n8. Personnel and resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.120\r\n\n\u25aa 29 CFR Part 1910.134 (m)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-1)\r\n\n\u25aa 29 CFR Part 1910.1450 (j)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 7.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-3 and -4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3) and (h)\r\n\n\u25aa OSHA 1910.1450 (throughout)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.198\r\n\n\u25aa 42 CFR Part 493.1233\r\n\n\u25aa BRC GSFS, Issue 8, 3.10.1\u20132\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\n\u25aa IFS Food 7, Part 2, 5.8\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.15\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\n\u25aa ASTM E1578-18 E-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CJIS Security Policy 5.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2\u20133\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\n\u25aa ASTM E1578-18 E-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\n\u25aa ASTM E1578-18 E-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASTM E1578-18 E-1-4\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (e)\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa AIHA-LAP Policies 2022 (various parts)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n8.9 The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.\r\n \r\n\r\n \r\n\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17 \r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 C-4-7\r\n\n\u25aa ASTM E1578-18 E-2-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-2\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\n\u25aa NIST 800-53, Rev. 5, AU-2 and AU-3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3 and AU-8\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa ASTM E1578-18 E-2-5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.70\r\n\u25aa E.U. Annex 11-14\r\n\u25aa NIST 800-53, Rev. 5, AU-10\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 493.1274 (d)\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6 and AU-12\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ISO\/IEC 17025:2017\n\n9.8 The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See LIMSpec for Cannabis Testing 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)\r\n \r\n\r\n \r\n\n\n\n\u25aa NELAC Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (2016)\r\n\u25aa NYS ELAP Certification\n\n9.9 The system should support a laboratory's NELAC or ELAP compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\u25aa A2LA R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program\n\n9.10 The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa 21 CFR Part 606.60\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1252 (b-3)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C223 5.5\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-7\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 6\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\n\u25aa ASTM E1578-18 E-3-8\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa A2LA C211 5.5.7\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa ABFT Accreditation Manual Sec. E-21\r\n\n\u25aa ASTM E1578-18 E-3-9\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.3\r\n\n\u25aa ISO 15189:2012 5.3.1.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.9\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 820.72 (b-2)\r\n\n\u25aa ASTM E1578-18 E-3-10\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.72 (b-1)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.6.2.1\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\n\u25aa USDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.105 (b)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.4 and 5.5.5\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\n\u25aa ASTM E1578-18 E-3-12\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.1\r\n\n\u25aa ISO 15189:2012 5.3.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 58.63\r\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 211.182\r\n\n\u25aa 21 CFR Part 211.194 (d)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1254\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C211 5.10.4\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20 and -23\r\n\n\u25aa ABFT Accreditation Manual Sec. F-1 and I-1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-14\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\u20135\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.46\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\r\n \r\n\r\n \r\n\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.105 (a)\r\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\r\n\n\u25aa OECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 820.65\r\n\n\u25aa ASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\r\n \r\n\r\n \r\n\n\n\n\u25aa E.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\r\n \r\n\r\n \r\n\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\u25aa ASTM E1578-18 E-5-1\r\n\u25aa USDA Sampling Procedures for PDP 5.6\u20137\r\n\n\n12.1 The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 212.61 (a)\r\n\u25aa 21 CFR Part 211.166 (b)\r\n\u25aa ASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n12.6 The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.\r\n \r\n\r\n \r\n\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\r\n \r\n\r\n \r\n\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.83\r\n\n\u25aa 29 CFR Part 1910.1200 (g)\r\n\n\u25aa 29 CFR Part 1910.1450 (h)\r\n\n\u25aa 42 CFR Part 493.1252 (c)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-17\r\n\n\u25aa ASTM E1578-18 E-7-1\r\n\n\u25aa ISO 15189:2012 5.3.2.4\u20135\r\n\n\u25aa OECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.3\r\n\n\u25aa 9 CFR Part 121.3\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 42 CFR Part 73.3\u20134 (c)\r\n\n\u25aa ASTM E1578-18 E-7-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.12\r\n\n\u25aa ISO 15189:2012 5.3.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-3\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-4\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-5\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\r\n \r\n\r\n \r\n\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-8-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa ASTM E1578-18 E-8-2\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e-6)\r\n\n\u25aa 29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n\u25aa 40 CFR Part 262.206\r\n\n\u25aa ASTM E1578-18 E-8-3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1200(b)(3) and (f)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 117.420\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 820.50\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.5.1.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\n\u25aa IFS Food 7, Part 2, 4.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.4.1\r\n\n\u25aa ISO\/TS 22002-1:2009, 9.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.6.2\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.6.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.1\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.196\r\n\n\u25aa 21 CFR Part 212.90\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 29 CFR Part 1910.1450 Appendix A (I)\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-5\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.82 (b)\r\n\n\u25aa 21 CFR Part 211.84 (a)\r\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 21 CFR Part 211.142 (a)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa ASTM E1578-18 E-8-6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\u25aa ASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\r\n \r\n\r\n \r\n\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 312.62 (b)\r\n\u25aa 21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 312.57 (a)\r\n\n\u25aa 21 CFR Part 312.62 (a)\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 58.81 (a)\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.111\r\n\n\u25aa 21 CFR Part 211.192\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 606.171\r\n\n\u25aa 42 CFR Part 493.1253 (b-2)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ABFT Accreditation Manual C-16\r\n\n\u25aa ABFT Accreditation Manual F-2\r\n\n\u25aa ABFT Accreditation Manual J-3\r\n\n\u25aa ASTM E1578-18 E-9-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.7\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 7.3\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.2.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1282\r\n\u25aa ASTM E1578-18 E-9-2\r\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 9\n\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa ASTM E1578-18 E-9-3\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa CLSI QMS22 2.2.2.3\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.12\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 21 CFR Part 112.147\r\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 21 CFR Part 820.100\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.9 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.6.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, IR-5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.9\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 11.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 42 CFR Part 493.1289\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.8 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-5\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy Appendix G.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6(1)\r\n\n\u25aa NIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2 and SI-4\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\r\n \r\n\r\n \r\n\n\n\n\u25aa 9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#8._Personnel_and_resource_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#8._Personnel_and_resource_management<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 22 June 2023, at 22:47.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","e4cd57c94f774a5adcaa21560153afd3_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px; width:175px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Personnel_and_resource_management\">8. Personnel and resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.9<\/b> The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.8<\/b> The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See <i>LIMSpec for Cannabis Testing<\/i> 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nelac-institute.org\/content\/CSDP\/standards.php\" target=\"_blank\">NELAC <i>Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis<\/i> (2016)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/elap\/requirements-for-laboratory-certification-certification\" target=\"_blank\">NYS ELAP Certification<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.9<\/b> The system should support a laboratory's NELAC or ELAP compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.a2la.org\/accreditation\/cannabis-testing\" target=\"_blank\">A2LA <i>R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program<\/i><\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.10<\/b> The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a><br \/>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.6<\/b> The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184907\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.138 seconds\nReal time usage: 0.155 seconds\nPreprocessor visited node count: 1470\/1000000\nPost\u2010expand include size: 159889\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 43.878 1 -total\n 12.76% 5.597 1 Template:LIMSpec_for_Cannabis_Testing\/Document_management\n 12.17% 5.338 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_and_equipment_management\n 11.93% 5.233 1 Template:LIMSpec_for_Cannabis_Testing\/Personnel_and_resource_management\n 10.29% 4.515 1 Template:LIMSpec_for_Cannabis_Testing\/Investigation_and_quality_management\n 10.06% 4.416 1 Template:LIMSpec_for_Cannabis_Testing\/Compliance_management\n 9.37% 4.113 1 Template:LIMSpec_for_Cannabis_Testing\/Batch_and_lot_management\n 8.85% 3.885 1 Template:LIMSpec_for_Cannabis_Testing\/Inventory_management\n 7.49% 3.287 1 Template:LIMSpec_for_Cannabis_Testing\/Standard_and_reagent_management\n 6.61% 2.901 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5468-0!canonical and timestamp 20230623184906 and revision id 18333. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#8._Personnel_and_resource_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#8._Personnel_and_resource_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","e4cd57c94f774a5adcaa21560153afd3_images":[],"e4cd57c94f774a5adcaa21560153afd3_timestamp":1687546820,"fe107b63e5120b5912d108b1124ee53b_type":"article","fe107b63e5120b5912d108b1124ee53b_title":"7. Document and records management","fe107b63e5120b5912d108b1124ee53b_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#7._Document_and_records_management","fe107b63e5120b5912d108b1124ee53b_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operationsFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 10 CFR Part 20 (throughout)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.213\u201314\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ABFT Accreditation Manual (throughout)\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.3\r\n\n\u25aa ISO\/IEC 17025:2017 5.5\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(e) and (h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331 (throughout)\r\n\n\u25aa 9 CFR Part 121 (throughout)\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 7 (throughout)\r\n\n\u25aa 21 CFR Part 58 (throughout)\r\n\n\u25aa 21 CFR Part 117 (throughout)\r\n\n\u25aa 21 CFR Part 211 (throughout)\r\n\n\u25aa 21 CFR Part 212 (throughout)\r\n\n\u25aa 21 CFR Part 225 (throughout)\r\n\n\u25aa 21 CFR Part 226 (throughout)\r\n\n\u25aa 21 CFR Part 312 (throughout)\r\n\n\u25aa 21 CFR Part 606 (throughout)\r\n\n\u25aa 21 CFR Part 810 (throughout)\r\n\n\u25aa 21 CFR Part 812 (throughout)\r\n\n\u25aa 21 CFR Part 820 (throughout)\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (throughout)\r\n\n\u25aa 29 CFR Part 1910.1200 (e)\r\n\n\u25aa 29 CFR Part 1910.1450 (throughout)\r\n\n\u25aa 40 CFR Part 262.214\r\n\n\u25aa 42 CFR Part 73 (throughout)\r\n\n\u25aa 42 CFR Part 93.300\u20135\r\n\n\u25aa 42 CFR Part 493.1200\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa 42 CFR Part 493.1239\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 42 CFR Part 493.1291 (j)\r\n\n\u25aa 42 CFR Part 493.1773 (c\u2013d)\r\n\n\u25aa 45 CFR Part 160.310\r\n\n\u25aa 45 CFR Part 164 (throughout)\r\n\n\u25aa 61 FR 38806 (throughout)\r\n\n\u25aa A2LA C211 (throughout)\r\n\n\u25aa A2LA C223 (throughout)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\n\u25aa AAVLD Requirements for an AVMDL (throughout)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\n\u25aa AIHA-LAP Policies 2022 Appendix H5.8\r\n\n\u25aa ASTM E1188-11 3.5.2\r\n\n\u25aa ASTM E1492-11 4.3.3.3 and 4.4.4\r\n\n\u25aa ASTM E1578-18 D-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 3.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.2\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual (throughout)\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\n\u25aa CJIS Security Policy (throughout)\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa EPA 815-R-05-004 (throughout)\r\n\n\u25aa EPA ERLN Laboratory Requirements (throughout)\r\n\n\u25aa EPA QA\/G-5 (throughout)\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC (throughout)\r\n\n\u25aa FDA Hazard Analysis Critical Control Point (throughout)\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\n\u25aa IFS Food 7, Part 2 (throughout)\r\n\n\u25aa IFS PACsecure 2, Part 2 (throughout)\r\n\n\u25aa ISO 15189:2012 (throughout)\r\n\n\u25aa ISO\/IEC 17025:2017 (throughout)\r\n\n\u25aa ISO\/TS 22002-1:2009 (throughout)\r\n\n\u25aa ISO\/TS 22002-4:2013 (throughout)\r\n\n\u25aa ISO\/TS 22002-6:2016 (throughout)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5 (throughout)\r\n\n\u25aa OECD GLP Principles 8\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa Safe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa USDA Data and Instrumentation for PDP (throughout)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\r\n\n\u25aa WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13 (throughout)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2 (throughout)\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 820.40 (a)\r\n\n\u25aa 42 CFR Part 493.1251 (e)\r\n\n\u25aa A2LA C211 4.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3\r\n\n\u25aa ASTM E1578-18 D-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.2\r\n\n\u25aa EPA QA\/G-5 2.1.9\r\n\n\u25aa ISO 15189:2012 4.3\r\n\n\u25aa ISO 15189:2012 5.5.3\r\n\n\u25aa ISO 15189:2012 5.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.3.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 1.1152 (e)\r\n\n\u25aa 21 CFR Part 106.91 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.160\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.60 (c)\r\n\n\u25aa 21 CFR Part 226.58 (e)\r\n\n\u25aa 21 CFR Part 820.250 (b)\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 D-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 5\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa IFS Food 7, Part 2, 5.5.2\r\n\n\u25aa IFS Food 7, Part 2, 5.6.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.5.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1151\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.320\r\n\n\u25aa 21 CFR Part 212.20 (c)\r\n\n\u25aa 21 CFR Part 212.70 (b)\r\n\n\u25aa A2LA C211 5.4.5\r\n\n\u25aa A2LA C223 5.4\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\n\u25aa ABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\n\u25aa Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\n\u25aa Codex Alimentarius CXS 234-1999 (throughout)\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 10.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 4.11\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.10\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 10 CFR Part 30.34 (j-3)\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.134 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa 40 CFR Part 262.210\u201312\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 42 CFR Part 493.1251\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.5\r\n\n\u25aa A2LA C211 5.2\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\n\u25aa AIHA-LAP Policies 2022 (throughout)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CLSI QMS22 (throughout)\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\n\u25aa EPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\r\n \r\n\r\n \r\n\n\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 4.3.4\r\n\u25aa ISO\/IEC 17025:2017 8.3.2\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\r\n \r\n\r\n \r\n\n\n\n\n8. Personnel and resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 9 CFR Part 2.32\r\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.120\r\n\n\u25aa 29 CFR Part 1910.134 (m)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-1)\r\n\n\u25aa 29 CFR Part 1910.1450 (j)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C211 4.13.2.3\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa A2LA C223 5.7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa BRC GSFS, Issue 8, 7.3.1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.1\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-3 and -4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1020 (throughout)\r\n\n\u25aa OSHA 1910.1200(b)(3) and (h)\r\n\n\u25aa OSHA 1910.1450 (throughout)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.198\r\n\n\u25aa 42 CFR Part 493.1233\r\n\n\u25aa BRC GSFS, Issue 8, 3.10.1\u20132\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\n\u25aa IFS Food 7, Part 2, 5.8\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.15\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\n\u25aa ASTM E1578-18 E-1-1\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CJIS Security Policy 5.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2\u20133\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\n\u25aa ASTM E1578-18 E-1-2\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 5 CFR Part 930.301\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 110.10 (c)\r\n\n\u25aa 21 CFR Part 120.12\r\n\n\u25aa 21 CFR Part 123.10\r\n\n\u25aa 29 CFR Part 1910.1450 (f)\r\n\n\u25aa 40 CFR Part 262.207\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\n\u25aa ASTM E1578-18 E-1-3\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.2.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.2.4.1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Guidelines\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\n\u25aa USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 9.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa ASTM E1578-18 E-1-4\r\n\n\u25aa IFS Food 7, Part 2, 3.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 E-1-5\r\n\n\u25aa BRC GSFS, Issue 8, 7.1.x\r\n\n\u25aa NIST 800-53, Rev. 5, AT-2 and AT-3\r\n\n\u25aa NIST 800-53, Rev. 5, CP-3\r\n\n\u25aa NIST 800-53, Rev. 5, IR-2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.15\r\n\n\u25aa 9 CFR Part 121.10 \r\n\n\u25aa 9 CFR Part 121.15 \r\n\n\u25aa 21 CFR Part 11.10 (i)\r\n\n\u25aa 21 CFR Part 58.29\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 211.25\r\n\n\u25aa 21 CFR Part 225.10\r\n\n\u25aa 21 CFR Part 226.10\r\n\n\u25aa 21 CFR Part 226.40\r\n\n\u25aa 21 CFR Part 820.25\r\n\n\u25aa 29 CFR Part 1910.1030 (g-2)\r\n\n\u25aa 29 CFR Part 1910.1030 (h-2)\r\n\n\u25aa 29 CFR Part 1910.1200 (h)\r\n\n\u25aa 29 CFR Part 1910.1450 (e)\r\n\n\u25aa 42 CFR Part 73.10\r\n\n\u25aa 42 CFR Part 73.15\r\n\n\u25aa 42 CFR Part 493.43 (c)\r\n\n\u25aa 42 CFR Part 493.1235\r\n\n\u25aa 45 CFR Part 164.308\r\n\n\u25aa 45 CFR Part 164.530\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa A2LA C223 5.2\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\n\u25aa AAVLD Requirements for an AVMDL Appendix 1\r\n\n\u25aa ABFT Accreditation Manual Sec. B\r\n\n\u25aa AIHA-LAP Policies 2022 (various parts)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\n\u25aa ASTM E1578-18 C-3-5\r\n\n\u25aa ASTM E1578-18 D-1-6\r\n\n\u25aa ASTM E1578-18 E-1-6\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa E.U. Annex 11-2\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 1\r\n\n\u25aa EPA QA\/G-5 2.1.8\r\n\n\u25aa ISO 15189:2012 4.1.2.1\r\n\n\u25aa ISO 15189:2012 5.1.6\r\n\n\u25aa ISO 15189:2012 5.1.9\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.3\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa OECD GLP Principles 1.1.2\r\n\n\u25aa USDA Administrative Procedures for the PDP 6.1\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n8.9 The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.\r\n \r\n\r\n \r\n\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17 \r\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 61 FR 38806, 9 CFR Part 310.25\r\n\n\u25aa 61 FR 38806, 9 CFR Part 381.94\r\n\n\u25aa ASTM E1578-18 C-4-7\r\n\n\u25aa ASTM E1578-18 E-2-1\r\n\n\u25aa BRC GSFS, Issue 8, 3.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-2\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CJIS Security Policy Appendix G.5\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\n\u25aa NIST 800-53, Rev. 5, AU-2 and AU-3\r\n\n\u25aa NIST 800-53, Rev. 5, CM-5(1)\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-3\r\n\n\u25aa BRC GSFS, Issue 8, 3.2.1\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.3.2\r\n\n\u25aa CLSI QMS22 2.4.3\r\n\n\u25aa E.U. Annex 11-12.4\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3 and AU-8\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 E-2-4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-3\r\n\n\u25aa OECD GLP Principles 8.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 11.70\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1251 (d)\r\n\n\u25aa 45 CFR Part 164.310\r\n\n\u25aa ASTM E1578-18 E-2-5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.6\r\n\n\u25aa E.U. Annex 11-14\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 11.70\r\n\u25aa E.U. Annex 11-14\r\n\u25aa NIST 800-53, Rev. 5, AU-10\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n\u25aa 21 CFR Part 11.10 (e)\r\n\n\u25aa 21 CFR Part 58.130 (e)\r\n\n\u25aa 42 CFR Part 493.1274 (d)\r\n\n\u25aa E.U. Annex 11-9\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6 and AU-12\r\n\n\u25aa OECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\r\n \r\n\r\n \r\n\n\n\n\u25aa ISO\/IEC 17025:2017\n\n9.8 The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See LIMSpec for Cannabis Testing 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)\r\n \r\n\r\n \r\n\n\n\n\u25aa NELAC Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (2016)\r\n\u25aa NYS ELAP Certification\n\n9.9 The system should support a laboratory's NELAC or ELAP compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\u25aa A2LA R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program\n\n9.10 The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.\r\n \r\n\r\n \r\n\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa 21 CFR Part 606.60\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1252 (b-3)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C223 5.5\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-7\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.6.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 6\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.30 (b-4)\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\n\u25aa ASTM E1578-18 E-3-8\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa A2LA C211 5.5.7\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa ABFT Accreditation Manual Sec. E-21\r\n\n\u25aa ASTM E1578-18 E-3-9\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.3\r\n\n\u25aa ISO 15189:2012 5.3.1.5\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.9\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 820.72 (b-2)\r\n\n\u25aa ASTM E1578-18 E-3-10\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 820.72 (b-1)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.6.2.1\r\n\n\u25aa A2LA C223 5.6\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa ISO\/IEC 17025:2017 6.5\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.7.1\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.7\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\n\u25aa USDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 110.40 (f)\r\n\n\u25aa 21 CFR Part 211.105 (b)\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 5.5.4 and 5.5.5\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\n\u25aa ASTM E1578-18 E-3-12\r\n\n\u25aa BRC GSFS, Issue 8, 6.4.x\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\n\u25aa IFS Food 7, Part 2, 5.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.1\r\n\n\u25aa ISO 15189:2012 5.3.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.8\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, CM-8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 20.2103\r\n\n\u25aa 21 CFR Part 58.63\r\n\n\u25aa 21 CFR Part 111.117\r\n\n\u25aa 21 CFR Part 211.67\u201368\r\n\n\u25aa 21 CFR Part 211.160 (b-4)\r\n\n\u25aa 21 CFR Part 211.182\r\n\n\u25aa 21 CFR Part 211.194 (d)\r\n\n\u25aa 21 CFR Part 212.30 (b)\r\n\n\u25aa 21 CFR Part 212.60 (e)\r\n\n\u25aa 21 CFR Part 820.70 (g)\r\n\n\u25aa 21 CFR Part 820.72\r\n\n\u25aa 42 CFR Part 493.1254\r\n\n\u25aa 42 CFR Part 493.1255\r\n\n\u25aa A2LA C211 4.13.2.1\r\n\n\u25aa A2LA C211 5.5.2\r\n\n\u25aa A2LA C211 5.10.4\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.5\r\n\n\u25aa ABFT Accreditation Manual Sec. E-20 and -23\r\n\n\u25aa ABFT Accreditation Manual Sec. F-1 and I-1\r\n\n\u25aa AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\n\u25aa ASTM E1578-18 E-3-14\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 7\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\n\u25aa EPA QA\/G-5 2.2.6\u20137\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\n\u25aa IFS Food 7, Part 2, 5.4.2\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.4.2\r\n\n\u25aa ISO 15189:2012 5.3.1.4\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.4\u20135\r\n\n\u25aa ISO\/IEC 17025:2017 6.4.13\r\n\n\u25aa NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 4.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\n\u25aa USDA Administrative Procedures for the PDP 5.2.4\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.46\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\r\n \r\n\r\n \r\n\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.105 (a)\r\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\r\n\n\u25aa OECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa ASTM E1578-18 E-4-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.80\r\n\n\u25aa 21 CFR Part 225.102\r\n\n\u25aa 21 CFR Part 226.102\r\n\n\u25aa 21 CFR Part 820.65\r\n\n\u25aa ASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\r\n \r\n\r\n \r\n\n\n\n\u25aa E.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\r\n \r\n\r\n \r\n\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\u25aa ASTM E1578-18 E-5-1\r\n\u25aa USDA Sampling Procedures for PDP 5.6\u20137\r\n\n\n12.1 The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 212.61 (a)\r\n\u25aa 21 CFR Part 211.166 (b)\r\n\u25aa ASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n12.6 The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.\r\n \r\n\r\n \r\n\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\r\n \r\n\r\n \r\n\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 58.83\r\n\n\u25aa 29 CFR Part 1910.1200 (g)\r\n\n\u25aa 29 CFR Part 1910.1450 (h)\r\n\n\u25aa 42 CFR Part 493.1252 (c)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-17\r\n\n\u25aa ASTM E1578-18 E-7-1\r\n\n\u25aa ISO 15189:2012 5.3.2.4\u20135\r\n\n\u25aa OECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.3\r\n\n\u25aa 9 CFR Part 121.3\r\n\n\u25aa 21 CFR Part 312.58 (b)\r\n\n\u25aa 42 CFR Part 73.3\u20134 (c)\r\n\n\u25aa ASTM E1578-18 E-7-2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.12\r\n\n\u25aa ISO 15189:2012 5.3.2.4\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-3\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-4\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-7-5\r\n\u25aa ISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\r\n \r\n\r\n \r\n\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 E-8-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa ASTM E1578-18 E-8-2\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 212.60 (d)\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e-6)\r\n\n\u25aa 29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n\u25aa 40 CFR Part 262.206\r\n\n\u25aa ASTM E1578-18 E-8-3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OSHA 1910.1200(b)(3) and (f)\r\n\n\u25aa OSHA 1910.1450(h)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 117.420\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 820.50\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.5.1.4\r\n\n\u25aa Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\n\u25aa IFS Food 7, Part 2, 4.4.1\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.4.1\r\n\n\u25aa ISO\/TS 22002-1:2009, 9.2\r\n\n\u25aa ISO\/TS 22002-4:2013, 4.6.2\r\n\n\u25aa ISO\/TS 22002-6:2016, 4.6.2\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\n\u25aa USDA Administrative Procedures for the PDP 7.1\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.196\r\n\n\u25aa 21 CFR Part 212.90\r\n\n\u25aa 21 CFR Part 225.110\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 29 CFR Part 1910.1450 Appendix A (I)\r\n\n\u25aa A2LA C211 4.6\r\n\n\u25aa ASTM E1578-18 E-8-5\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.82 (b)\r\n\n\u25aa 21 CFR Part 211.84 (a)\r\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 21 CFR Part 211.142 (a)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa ASTM E1578-18 E-8-6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\n\u25aa 21 CFR Part 211.110 (d)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.89\r\n\u25aa ASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\r\n \r\n\r\n \r\n\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 312.62 (b)\r\n\u25aa 21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 312.57 (a)\r\n\n\u25aa 21 CFR Part 312.62 (a)\r\n\n\u25aa 21 CFR Part 606.165\r\n\n\u25aa 21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 58.81 (a)\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.111\r\n\n\u25aa 21 CFR Part 211.192\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 606.171\r\n\n\u25aa 42 CFR Part 493.1253 (b-2)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ABFT Accreditation Manual C-16\r\n\n\u25aa ABFT Accreditation Manual F-2\r\n\n\u25aa ABFT Accreditation Manual J-3\r\n\n\u25aa ASTM E1578-18 E-9-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.3\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.4\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.3\r\n\n\u25aa EPA QA\/G-5 2.2.4\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.1.7\r\n\n\u25aa ISO\/IEC 17025:2017 7.2.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.10.2\r\n\n\u25aa ISO\/IEC 17025:2017 8.7\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 7.3\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.2.2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1282\r\n\u25aa ASTM E1578-18 E-9-2\r\n\u25aa E.U. Commission Reg. No. 2073\/2005 Article 9\n\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa ASTM E1578-18 E-9-3\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa CLSI QMS22 2.2.2.3\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.12\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 10 CFR Part 30.34 (g)\r\n\n\u25aa 21 CFR Part 112.147\r\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 21 CFR Part 606.100 (c)\r\n\n\u25aa 21 CFR Part 820.100\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.9 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-4\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.6.4\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, IR-5\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.9\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 11.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 225.58 (d)\r\n\n\u25aa 21 CFR Part 225.158\r\n\n\u25aa 42 CFR Part 493.1282\r\n\n\u25aa 42 CFR Part 493.1289\r\n\n\u25aa 61 FR 38806, 9 CFR Part 417.3\r\n\n\u25aa A2LA C211 4.8 and 4.11\r\n\n\u25aa ASTM E1578-18 E-9-5\r\n\n\u25aa BRC GSFS, Issue 8, 3.4.3\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\n\u25aa CJIS Security Policy 5.3.4\r\n\n\u25aa CJIS Security Policy Appendix G.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 13\r\n\n\u25aa FDA Hazard Analysis Critical Control Point Principle 5\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa NIST 800-53, Rev. 5, AU-6(1)\r\n\n\u25aa NIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\n\u25aa NIST 800-53, Rev. 5, SI-2 and SI-4\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\r\n \r\n\r\n \r\n\n\n\n\u25aa 9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#7._Document_and_records_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#7._Document_and_records_management<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 22 June 2023, at 22:47.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","fe107b63e5120b5912d108b1124ee53b_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Maintaining_laboratory_workflow_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Maintaining laboratory workflow and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px; width:175px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"8._Personnel_and_resource_management\">8. Personnel and resource management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>8.9<\/b> The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.8<\/b> The system should support a laboratory's ISO\/IEC 17025:2017 compliance efforts. (See <i>LIMSpec for Cannabis Testing<\/i> 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO\/IEC 17025:2017-supported requirements.)<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nelac-institute.org\/content\/CSDP\/standards.php\" target=\"_blank\">NELAC <i>Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis<\/i> (2016)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/elap\/requirements-for-laboratory-certification-certification\" target=\"_blank\">NYS ELAP Certification<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.9<\/b> The system should support a laboratory's NELAC or ELAP compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.a2la.org\/accreditation\/cannabis-testing\" target=\"_blank\">A2LA <i>R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program<\/i><\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>9.10<\/b> The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by instrument type, sample types tested, and laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a><br \/>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>12.6<\/b> The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184907\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.138 seconds\nReal time usage: 0.155 seconds\nPreprocessor visited node count: 1470\/1000000\nPost\u2010expand include size: 159889\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 43.878 1 -total\n 12.76% 5.597 1 Template:LIMSpec_for_Cannabis_Testing\/Document_management\n 12.17% 5.338 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_and_equipment_management\n 11.93% 5.233 1 Template:LIMSpec_for_Cannabis_Testing\/Personnel_and_resource_management\n 10.29% 4.515 1 Template:LIMSpec_for_Cannabis_Testing\/Investigation_and_quality_management\n 10.06% 4.416 1 Template:LIMSpec_for_Cannabis_Testing\/Compliance_management\n 9.37% 4.113 1 Template:LIMSpec_for_Cannabis_Testing\/Batch_and_lot_management\n 8.85% 3.885 1 Template:LIMSpec_for_Cannabis_Testing\/Inventory_management\n 7.49% 3.287 1 Template:LIMSpec_for_Cannabis_Testing\/Standard_and_reagent_management\n 6.61% 2.901 1 Template:LIMSpec_for_Cannabis_Testing\/Instrument_data_capture_and_control\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5468-0!canonical and timestamp 20230623184906 and revision id 18333. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#7._Document_and_records_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#7._Document_and_records_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","fe107b63e5120b5912d108b1124ee53b_images":[],"fe107b63e5120b5912d108b1124ee53b_timestamp":1687546820,"60bb82c8eae2932c0b0770c6c668caf1_type":"article","60bb82c8eae2932c0b0770c6c668caf1_title":"6. Reporting","60bb82c8eae2932c0b0770c6c668caf1_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#6._Reporting","60bb82c8eae2932c0b0770c6c668caf1_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Primary laboratory workflowFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.\n\n1. Sample and experiment registration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 1.1149\r\n\u25aa 42 CFR Part 493.1241\r\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\u25aa ASTM E1578-18 C-1-1\n\n1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 58.105 (c)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 21 CFR Part 606.121 (c\u2013i)\r\n\n\u25aa 21 CFR Part 606.140 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e1-6)\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa ABFT Accreditation Manual Sec. D\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1492-11 4.1.1.6\r\n\n\u25aa ASTM E1578-18 C-1-2\r\n\n\u25aa CLSI QMS22 2.2.1.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.2\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 15\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.2.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.2 The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 162.410\r\n\u25aa CJIS Security Policy 5.6.1\n\n1.3 The system shall provide a means to assign unique identifiers such as a U.S. Department of Food and Agriculture unique cultivator identifier to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1241\r\n\u25aa ASTM E1578-18 C-1-3\n\n1.4 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.19\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 40 CFR Part 262.18\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C2.1\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 C-1-4\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.1.3\n\n\n1.5 The system should permit metadata like lot number, field number, client demographics, sampling point, random selection process used, and other cannabis-specific identifiers to be included during registration.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-5\n\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-6\n\n1.7 The system, when applicable, should offer safety information related to a submitted cannabis-related sample upon registration, which is relevant to the lab's location and sample type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-7\n\n1.8 The system should support the creation, use, and configuration of predefined metadata templates, capturing metadata mandated by state and local laws and regulations for various cannabis substrates\/matrices and derivative products, as well as any other ad-hoc, single, and multiple samples.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.19\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.105 (c)\r\n\n\u25aa 21 CFR Part 58.195\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.170\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 312.57 (d)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1105\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa 42 CFR Part 493.1242\r\n\n\u25aa 42 CFR Part 493.1274 (f)\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.7.1.2\r\n\n\u25aa ABFT Accreditation Manual Sec. D\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C2\r\n\n\u25aa ASTM E1578-18 C-1-8\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6 and 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8\r\n\n\u25aa EPA 815-R-05-004 Supplement 1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.10\u201311\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.7.1\u20136\r\n\n\u25aa EPA QA\/G-5 2.2.2 and 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\n\u25aa ISO 15189:2012 5.7.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.3.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13\r\n\n\u25aa USDA Sampling Procedures for PDP 5.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21\n\n\n1.9 The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-1-9\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G1.4\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.5\n\n\n1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-10\n\n1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens\u2014including associated measurement units and any other regulation-mandated attributes\u2014based upon the various cannabis substrates\/matrices and derivative products tested, as well as the sample source location and\/or laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa ASTM E1578-18 C-1-11\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2\n\n\n1.12 The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.107 (c)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.8.2\r\n\n\u25aa ABFT Accreditation Manual D-3\r\n\n\u25aa ASTM E1578-18 C-1-12\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.10\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 15\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.2\r\n\n\u25aa OECD GLP Principles 6.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1.11\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.2.5\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 58.107 (d)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1578-18 C-1-13\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.7\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)\n\n\n1.14 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa ASTM E1578-18 C-1-14\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.6\n\n\n1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C3.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.8.3\r\n\n\u25aa ASTM E1492-11 4.1.1.5\r\n\n\u25aa ASTM E1492-11 4.1.6\r\n\n\u25aa ASTM E1492-11 4.3.3.2\r\n\n\u25aa ASTM E1578-18 C-1-15\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.1.9\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1\n\n\n1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa A2LA C211 5.7\r\n\n\u25aa ASTM E1578-18 C-1-16\r\n\n\u25aa EPA QA\/G-5 2.2.2 and 2.2.3\n\n\n1.17 The system should provide a means to document and associate sample preparation activities such as grinding, homogenization, extraction, filtration, and evaporation with a given sample, batch, method, protocol, etc.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa A2LA C223 5.8\r\n\n\u25aa ABFT Accreditation Manual Sec. D-9\u201310\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1\r\n\n\u25aa ASTM E1578-18 C-1-17\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 12\r\n\n\u25aa EPA 815-R-05-004 Appendix A\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.3\u20135\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.8\u20139\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10(3)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\n\n\n1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\r\n \r\n\r\n \r\n\n\n\n\u25aa 7 CFR Part 331.16\r\n\u25aa 9 CFR Part 121.16\r\n\u25aa 42 CFR Part 73.16\n\n1.19 In the case of regulated samples such as cannabis, the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required shipping information.\r\n \r\n\r\n \r\n\n\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G1.1\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n1.20 The system shall be able to link various records together based on a record's metadata, including shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, customer, and more.\r\n \r\n\r\n \r\n\n\n\n\n2. Sample management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 C-2-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\n\n\n2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-2\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-3\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-4\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.4 The system shall require the recording of a standard and reagent's first opening date.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-5\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.5 The system shall allow only active standards and reagents to be shown as available for use.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-6\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-7\n\n2.7 The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, lot or batch ID, field number, test method, assigned user, and status.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-8\r\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\u25aa ISO\/IEC 17025:2017 7.4.2\n\n2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1492-11 4.2.1\r\n\n\u25aa ASTM E1578-18 C-2-9\r\n\n\u25aa CAP Laboratory Accreditation Manual\n\n\n2.9 The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1\r\n\n\u25aa ASTM E1578-18 C-2-10\n\n\n2.10 The system shall be able to link test methods and specifications to standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1153 (c)\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.166\u20137\r\n\n\u25aa 21 CFR Part 211.194 (e)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 212.61\r\n\n\u25aa 21 CFR Part 212.70 (e)\r\n\n\u25aa 21 CFR Part 225.58\r\n\n\u25aa 21 CFR Part 226.58\r\n\n\u25aa 21 CFR Part 606.65 (c)\r\n\n\u25aa 21 CFR Part 606.151\r\n\n\u25aa A2LA C223 5.9\r\n\n\u25aa ACMG Technical Standards for Clinical \u25aa Genetics Laboratories C6.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa ASTM E1578-18 C-2-11\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.1.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.3.2\r\n\n\u25aa EPA QA\/G-5 2.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.7.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.5\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.7\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 12.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.7\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.22\u201325\n\n\n2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa FDA Q1A(R2)\n\n2.12 The system should allow authorized users to create projects and research studies in the system\u2014including, e.g., stability studies\u2014and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.\r\n \r\n\r\n \r\n\n\n\n\n3. Core laboratory testing and experiments \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 211.84 (d)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1\r\n\n\u25aa ASTM E1578-18 C-3-1\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa ISO 15189:2012 5.3.2.7\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84 (e)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 C-3-2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\u25aa ASTM E1578-18 C-3-3\n\n3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-4\n\n3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-6\n\n3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-7\n\n3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-8\n\n3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-9\n\n3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-10\n\n3.9 The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\r\n \r\n\r\n \r\n\n\n\n\u25aa AIHA-LAP Policies 2018 2A.7.8.2\r\n\u25aa ASTM E1578-18 C-3-11\n\n3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-12\n\n3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1241\r\n\u25aa ASTM E1578-18 C-3-13\r\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\n\n3.12 The system should effectively alert users upon entry of out-of-specification test results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 1.1153 (c)\r\n\n\u25aa 21 CFR Part 106.100 (c\u2013f)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.325\r\n\n\u25aa 21 CFR Part 112.161\r\n\n\u25aa 21 CFR Part 114.100 (a)\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 212.60 (g)\r\n\n\u25aa 21 CFR Part 507.202\r\n\n\u25aa 21 CFR Part 606.160\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G16.1\r\n\n\u25aa A2LA C223 5.10\n\u25aa ASTM E1578-18 C-3-14\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.1.2.3\u20134\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.1\u20134\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.16\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\n\u25aa IFS Food 7, Part 2, 4.18.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.18.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.8\n\n\n3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\r\n \r\n\r\n \r\n\n\n\n\u25aa WADA International Standard for Laboratories (ISL) 1.2\n\n3.14 The system shall allow users to link samples, batches, and tests to a specific accreditation approval status (e.g., ANSI National Accreditation Board accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\r\n \r\n\r\n \r\n\n\n\n\n4. Results review and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa ASTM E1578-18 C-4-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa ISO 15189:2012 5.5.1.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-2\r\n\n\u25aa CLSI AUTO15 1.2\n\u25aa EPA ERLN Laboratory Requirements 4.9.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa ISO 15189:2012 5.9.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 C-4-3\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n4.3 The system shall accurately maintain a full audit trail for modified results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa A2LA C211 5.9.1\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa ABFT Accreditation Manual Sec. E-28\u201329\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G15.1\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135\r\n\n\u25aa ASTM E1578-18 C-4-4\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.4\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\r\n\n\u25aa IFS Food 7, Part 2, 5.6.4\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.4\r\n\n\u25aa ISO 15189:2012 5.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.1.1\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10(3)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa USDA Data and Instrumentation for PDP 10\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.1\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1\n\n\n4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\r\n\n\u25aa IFS Food 7, Part 2, 5.6.4\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.4\r\n\n\u25aa ISO 15189:2012 5.9.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-6\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\n\n\n4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI AUTO15 4.0\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n\n\n\n 5. Sample, experiment, and study approval and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 C-5-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.12.1\n\n\n5.1 The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa AIHA-LAP Policies 2022 2A.7.7.2\r\n\n\u25aa ASTM E1578-18 C-5-2\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.160 (b)\r\n\u25aa ASTM E1578-18 C-5-3\r\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6.1\n\n5.3 The system should provide appropriate functions for specific sample statuses like \"approved,\" \"rejected,\" and \"cancelled,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\r\n \r\n\r\n \r\n\n\n\n\n6. Reporting \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 C-6-1\n\n6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\r\n \r\n\r\n \r\n\n\n\n\u25aa EPA ERLN Laboratory Requirements 3.4\r\n\u25aa EPA ERLN Laboratory Requirements 4.1.4\r\n\u25aa EPA ERLN Laboratory Requirements 4.12\u201315\n\n6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1291 (g) and (h)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.2\r\n\n\u25aa ASTM E1578-18 C-6-2\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.4\r\n\n\u25aa EPA QA\/G-5 2.4.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n6.3 The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.\r\n \r\n\r\n \r\n\n\n\n\u25aa ABFT Accreditation Manual Sec. G-2\n\n6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.25\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 42 CFR Part 493.1291 (c\u2013e)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.8.1\r\n\n\u25aa ABFT Accreditation Manual Sec. E-12 and -32\r\n\n\u25aa ASTM E1578-18 C-6-3\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8\r\n\n\u25aa ISO 15189:2012 4.5.2\r\n\n\u25aa ISO 15189:2012 5.8.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.1.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.3.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.43\n\n\n6.5 The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.\r\n \r\n\r\n \r\n\n\n\n\u25aa 7 CFR Part 91.26\u201327\r\n\u25aa 21 CFR Part 1.1152 (d)\r\n\u25aa ASTM E1578-18 C-6-4\n\n6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa A2LA C211 5.10\r\n\n\u25aa ASTM E1578-18 C-6-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.2.3\r\n\n\u25aa ISO 15189:2012 5.8.1\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.5\r\n\n\u25aa 9 CFR Part 121.5\u20136\r\n\n\u25aa 21 CFR Part 1.1110\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 58.185\r\n\n\u25aa 21 CFR Part 312.64\r\n\n\u25aa 21 CFR Part 812.150\r\n\n\u25aa 40 CFR Part 141.31\r\n\n\u25aa 40 CFR Part 141.721\r\n\n\u25aa 40 CFR Part 370 Subpart C\r\n\n\u25aa 40 CFR Part 372 Subpart B\r\n\n\u25aa 40 CFR Part 704\r\n\n\u25aa 40 CFR Part 717 Subpart A\r\n\n\u25aa 40 CFR Part 720.40\r\n\n\u25aa 42 CFR Part 73.5\u20136\r\n\n\u25aa 42 CFR Part 493.43 (d)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories E8\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G17.1\r\n\n\u25aa ASTM E1578-18 C-6-7\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.12\u201315\r\n\n\u25aa EPA QA\/G-5 2.3.2\r\n\n\u25aa IFS Food 7, Part 4, 2.x\r\n\n\u25aa IFS PACsecure 2, Part 4, 1.x\r\n\n\u25aa NIST 800-53, Rev. 5, IR-6 and IR-6(1)\r\n\n\u25aa OECD GLP Principles 9.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.28\r\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 58 Sec. 58.185 (c)\r\n\n\u25aa A2LA C211 5.10.9\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310\r\n\n\u25aa CLSI QMS22 2.2.3.4\r\n\n\u25aa ICH GCP 4.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 9.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)\n\n\n6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n6.10 The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n6.11 The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#6._Reporting\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#6._Reporting<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 23 December 2020, at 19:53.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","60bb82c8eae2932c0b0770c6c668caf1_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Primary_laboratory_workflow rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Primary_laboratory_workflow skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Primary laboratory workflow<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"1._Sample_and_experiment_registration\">1. Sample and experiment registration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.1<\/b> The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.121\" target=\"_blank\">21 CFR Part 606.121 (c\u2013i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.140\" target=\"_blank\">21 CFR Part 606.140 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e1-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.2<\/b> The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.410\" target=\"_blank\">45 CFR Part 162.410<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.3<\/b> The system shall provide a means to assign unique identifiers such as a U.S. Department of Food and Agriculture unique cultivator identifier to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.4<\/b> The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.18\" target=\"_blank\">40 CFR Part 262.18<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.5<\/b> The system should permit metadata like lot number, field number, client demographics, sampling point, random selection process used, and other cannabis-specific identifiers to be included during registration.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.6<\/b> The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.7<\/b> The system, when applicable, should offer safety information related to a submitted cannabis-related sample upon registration, which is relevant to the lab's location and sample type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.8<\/b> The system should support the creation, use, and configuration of predefined metadata templates, capturing metadata mandated by state and local laws and regulations for various cannabis substrates\/matrices and derivative products, as well as any other ad-hoc, single, and multiple samples.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px;;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.170\" target=\"_blank\">21 CFR Part 211.170<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1242\" target=\"_blank\">42 CFR Part 493.1242<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.7.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6 and 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=P1000PUE.txt\" target=\"_blank\">EPA 815-R-05-004 Supplement 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10\u201311<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.7.1\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.9<\/b> The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.10<\/b> The system should allow for the addition of observations and descriptions to registered samples in the form of free text.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.11<\/b> The system should support the creation of user-definable default sample registration preferences and\/or input screens\u2014including associated measurement units and any other regulation-mandated attributes\u2014based upon the various cannabis substrates\/matrices and derivative products tested, as well as the sample source location and\/or laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.12<\/b> The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual D-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.13<\/b> The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.14<\/b> The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.15<\/b> The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.16<\/b> The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.17<\/b> The system should provide a means to document and associate sample preparation activities such as grinding, homogenization, extraction, filtration, and evaporation with a given sample, batch, method, protocol, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Appendix A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.3\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.8\u20139<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.18<\/b> The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.16\" target=\"_blank\">7 CFR Part 331.16<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.16\" target=\"_blank\">9 CFR Part 121.16<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.16\" target=\"_blank\">42 CFR Part 73.16<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.19<\/b> In the case of regulated samples such as cannabis, the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required shipping information.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.20<\/b> The system shall be able to link various records together based on a record's metadata, including shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, customer, and more.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"2._Sample_management\">2. Sample management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th scope=\"col\" style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.1<\/b> The system shall record and maintain the chain of custody for the laboratory's standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.2<\/b> The system shall record the current and historical storage location for the laboratory's standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.3<\/b> The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.4<\/b> The system shall require the recording of a standard and reagent's first opening date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.5<\/b> The system shall allow only active standards and reagents to be shown as available for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-6<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.6<\/b> The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.7<\/b> The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, lot or batch ID, field number, test method, assigned user, and status.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-8<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.8<\/b> The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.9<\/b> The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.10<\/b> The system shall be able to link test methods and specifications to standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.65\" target=\"_blank\">21 CFR Part 606.65 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.151\" target=\"_blank\">21 CFR Part 606.151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical \u25aa Genetics Laboratories C6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 12.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.22\u201325<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.11<\/b> The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q1ar2-stability-testing-new-drug-substances-and-products\" target=\"_blank\">FDA Q1A(R2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.12<\/b> The system should allow authorized users to create projects and research studies in the system\u2014including, e.g., stability studies\u2014and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"3._Core_laboratory_testing_and_experiments\">3. Core laboratory testing and experiments<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.1<\/b> The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.2<\/b> The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.3<\/b> The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.4<\/b> The system shall be able to check physical, control, and specification limits for an instrument sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.5<\/b> The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.6<\/b> The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.7<\/b> The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-9<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.8<\/b> The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.9<\/b> The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.8.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.10<\/b> The system shall allow users to enter operators such as <, >, +, and - with numeric test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.11<\/b> The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-13<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.12<\/b> The system should effectively alert users upon entry of out-of-specification test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (c\u2013f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.325<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.161<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.202<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G16.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.10<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.1\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.13<\/b> The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.14<\/b> The system shall allow users to link samples, batches, and tests to a specific accreditation approval status (e.g., ANSI National Accreditation Board accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"4._Results_review_and_verification\">4. Results review and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.1<\/b> The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 1.2<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.2<\/b> The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.3<\/b> The system shall accurately maintain a full audit trail for modified results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-28\u201329<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G15.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.4<\/b> The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.5<\/b> The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.6<\/b> The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 4.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.7<\/b> The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span id=\"rdp-ebb-5._Sample,_experiment,_and_study_approval_and_verification\"><\/span><span class=\"mw-headline\" id=\"5._Sample.2C_experiment.2C_and_study_approval_and_verification\">5. Sample, experiment, and study approval and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.12.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.1<\/b> The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.2<\/b> The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-5-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.3<\/b> The system should provide appropriate functions for specific sample statuses like \"approved,\" \"rejected,\" and \"cancelled,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"6._Reporting\">6. Reporting<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.1<\/b> The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.2<\/b> The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (g) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.3<\/b> The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.4<\/b> The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.25\" target=\"_blank\">7 CFR Part 91.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (c\u2013e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-12 and -32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.43<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.5<\/b> The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.26\" target=\"_blank\">7 CFR Part 91.26\u201327<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.6<\/b> The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.7<\/b> The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.5\" target=\"_blank\">7 CFR Part 331.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.5\" target=\"_blank\">9 CFR Part 121.5\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58.185<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.64\" target=\"_blank\">21 CFR Part 312.64<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.150\" target=\"_blank\">21 CFR Part 812.150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.31\" target=\"_blank\">40 CFR Part 141.31<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.721\" target=\"_blank\">40 CFR Part 141.721<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\/subpart-C\" target=\"_blank\">40 CFR Part 370 Subpart C<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\/subpart-B\" target=\"_blank\">40 CFR Part 372 Subpart B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\/subpart-A\" target=\"_blank\">40 CFR Part 717 Subpart A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.40\" target=\"_blank\">40 CFR Part 720.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.5\" target=\"_blank\">42 CFR Part 73.5\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 4, 2.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 4, 1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-6 and IR-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.8<\/b> The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.28\" target=\"_blank\">7 CFR Part 91.28<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58 Sec. 58.185 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.9<\/b> The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.10<\/b> The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.11<\/b> The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184906\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.079 seconds\nReal time usage: 0.089 seconds\nPreprocessor visited node count: 816\/1000000\nPost\u2010expand include size: 90373\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 24.344 1 -total\n 19.01% 4.628 1 Template:LIMSpec_for_Cannabis_Testing\/Sample_and_experiment_registration\n 17.01% 4.141 1 Template:LIMSpec_for_Cannabis_Testing\/Reporting\n 16.00% 3.895 1 Template:LIMSpec_for_Cannabis_Testing\/Sample_management\n 15.75% 3.835 1 Template:LIMSpec_for_Cannabis_Testing\/Results_review_and_verification\n 14.87% 3.621 1 Template:LIMSpec_for_Cannabis_Testing\/Core_laboratory_testing_and_experiments\n 13.86% 3.374 1 Template:LIMSpec_for_Cannabis_Testing\/Sample,_experiment,_and_study_approval_and_verification\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5461-0!canonical and timestamp 20230623184905 and revision id 16306. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#6._Reporting\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#6._Reporting<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","60bb82c8eae2932c0b0770c6c668caf1_images":[],"60bb82c8eae2932c0b0770c6c668caf1_timestamp":1687546820,"3ba7a90aa5cf7c32844e9a2b57c49fb5_type":"article","3ba7a90aa5cf7c32844e9a2b57c49fb5_title":"5. Sample, experiment, and study approval and verification","3ba7a90aa5cf7c32844e9a2b57c49fb5_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#5._Sample.2C_experiment.2C_and_study_approval_and_verification","3ba7a90aa5cf7c32844e9a2b57c49fb5_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Primary laboratory workflowFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.\n\n1. Sample and experiment registration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 1.1149\r\n\u25aa 42 CFR Part 493.1241\r\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\u25aa ASTM E1578-18 C-1-1\n\n1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 58.105 (c)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 21 CFR Part 606.121 (c\u2013i)\r\n\n\u25aa 21 CFR Part 606.140 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e1-6)\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa ABFT Accreditation Manual Sec. D\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1492-11 4.1.1.6\r\n\n\u25aa ASTM E1578-18 C-1-2\r\n\n\u25aa CLSI QMS22 2.2.1.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.2\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 15\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.2.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.2 The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 162.410\r\n\u25aa CJIS Security Policy 5.6.1\n\n1.3 The system shall provide a means to assign unique identifiers such as a U.S. Department of Food and Agriculture unique cultivator identifier to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1241\r\n\u25aa ASTM E1578-18 C-1-3\n\n1.4 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.19\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 40 CFR Part 262.18\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C2.1\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 C-1-4\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.1.3\n\n\n1.5 The system should permit metadata like lot number, field number, client demographics, sampling point, random selection process used, and other cannabis-specific identifiers to be included during registration.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-5\n\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-6\n\n1.7 The system, when applicable, should offer safety information related to a submitted cannabis-related sample upon registration, which is relevant to the lab's location and sample type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-7\n\n1.8 The system should support the creation, use, and configuration of predefined metadata templates, capturing metadata mandated by state and local laws and regulations for various cannabis substrates\/matrices and derivative products, as well as any other ad-hoc, single, and multiple samples.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.19\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.105 (c)\r\n\n\u25aa 21 CFR Part 58.195\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.170\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 312.57 (d)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1105\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa 42 CFR Part 493.1242\r\n\n\u25aa 42 CFR Part 493.1274 (f)\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.7.1.2\r\n\n\u25aa ABFT Accreditation Manual Sec. D\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C2\r\n\n\u25aa ASTM E1578-18 C-1-8\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6 and 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8\r\n\n\u25aa EPA 815-R-05-004 Supplement 1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.10\u201311\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.7.1\u20136\r\n\n\u25aa EPA QA\/G-5 2.2.2 and 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\n\u25aa ISO 15189:2012 5.7.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.3.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13\r\n\n\u25aa USDA Sampling Procedures for PDP 5.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21\n\n\n1.9 The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-1-9\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G1.4\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.5\n\n\n1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-10\n\n1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens\u2014including associated measurement units and any other regulation-mandated attributes\u2014based upon the various cannabis substrates\/matrices and derivative products tested, as well as the sample source location and\/or laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa ASTM E1578-18 C-1-11\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2\n\n\n1.12 The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.107 (c)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.8.2\r\n\n\u25aa ABFT Accreditation Manual D-3\r\n\n\u25aa ASTM E1578-18 C-1-12\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.10\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 15\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.2\r\n\n\u25aa OECD GLP Principles 6.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1.11\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.2.5\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 58.107 (d)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1578-18 C-1-13\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.7\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)\n\n\n1.14 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa ASTM E1578-18 C-1-14\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.6\n\n\n1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C3.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.8.3\r\n\n\u25aa ASTM E1492-11 4.1.1.5\r\n\n\u25aa ASTM E1492-11 4.1.6\r\n\n\u25aa ASTM E1492-11 4.3.3.2\r\n\n\u25aa ASTM E1578-18 C-1-15\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.1.9\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1\n\n\n1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa A2LA C211 5.7\r\n\n\u25aa ASTM E1578-18 C-1-16\r\n\n\u25aa EPA QA\/G-5 2.2.2 and 2.2.3\n\n\n1.17 The system should provide a means to document and associate sample preparation activities such as grinding, homogenization, extraction, filtration, and evaporation with a given sample, batch, method, protocol, etc.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa A2LA C223 5.8\r\n\n\u25aa ABFT Accreditation Manual Sec. D-9\u201310\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1\r\n\n\u25aa ASTM E1578-18 C-1-17\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 12\r\n\n\u25aa EPA 815-R-05-004 Appendix A\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.3\u20135\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.8\u20139\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10(3)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\n\n\n1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\r\n \r\n\r\n \r\n\n\n\n\u25aa 7 CFR Part 331.16\r\n\u25aa 9 CFR Part 121.16\r\n\u25aa 42 CFR Part 73.16\n\n1.19 In the case of regulated samples such as cannabis, the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required shipping information.\r\n \r\n\r\n \r\n\n\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G1.1\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n1.20 The system shall be able to link various records together based on a record's metadata, including shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, customer, and more.\r\n \r\n\r\n \r\n\n\n\n\n2. Sample management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 C-2-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\n\n\n2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-2\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-3\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-4\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.4 The system shall require the recording of a standard and reagent's first opening date.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-5\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.5 The system shall allow only active standards and reagents to be shown as available for use.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-6\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-7\n\n2.7 The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, lot or batch ID, field number, test method, assigned user, and status.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-8\r\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\u25aa ISO\/IEC 17025:2017 7.4.2\n\n2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1492-11 4.2.1\r\n\n\u25aa ASTM E1578-18 C-2-9\r\n\n\u25aa CAP Laboratory Accreditation Manual\n\n\n2.9 The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1\r\n\n\u25aa ASTM E1578-18 C-2-10\n\n\n2.10 The system shall be able to link test methods and specifications to standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1153 (c)\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.166\u20137\r\n\n\u25aa 21 CFR Part 211.194 (e)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 212.61\r\n\n\u25aa 21 CFR Part 212.70 (e)\r\n\n\u25aa 21 CFR Part 225.58\r\n\n\u25aa 21 CFR Part 226.58\r\n\n\u25aa 21 CFR Part 606.65 (c)\r\n\n\u25aa 21 CFR Part 606.151\r\n\n\u25aa A2LA C223 5.9\r\n\n\u25aa ACMG Technical Standards for Clinical \u25aa Genetics Laboratories C6.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa ASTM E1578-18 C-2-11\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.1.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.3.2\r\n\n\u25aa EPA QA\/G-5 2.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.7.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.5\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.7\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 12.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.7\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.22\u201325\n\n\n2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa FDA Q1A(R2)\n\n2.12 The system should allow authorized users to create projects and research studies in the system\u2014including, e.g., stability studies\u2014and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.\r\n \r\n\r\n \r\n\n\n\n\n3. Core laboratory testing and experiments \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 211.84 (d)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1\r\n\n\u25aa ASTM E1578-18 C-3-1\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa ISO 15189:2012 5.3.2.7\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84 (e)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 C-3-2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\u25aa ASTM E1578-18 C-3-3\n\n3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-4\n\n3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-6\n\n3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-7\n\n3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-8\n\n3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-9\n\n3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-10\n\n3.9 The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\r\n \r\n\r\n \r\n\n\n\n\u25aa AIHA-LAP Policies 2018 2A.7.8.2\r\n\u25aa ASTM E1578-18 C-3-11\n\n3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-12\n\n3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1241\r\n\u25aa ASTM E1578-18 C-3-13\r\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\n\n3.12 The system should effectively alert users upon entry of out-of-specification test results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 1.1153 (c)\r\n\n\u25aa 21 CFR Part 106.100 (c\u2013f)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.325\r\n\n\u25aa 21 CFR Part 112.161\r\n\n\u25aa 21 CFR Part 114.100 (a)\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 212.60 (g)\r\n\n\u25aa 21 CFR Part 507.202\r\n\n\u25aa 21 CFR Part 606.160\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G16.1\r\n\n\u25aa A2LA C223 5.10\n\u25aa ASTM E1578-18 C-3-14\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.1.2.3\u20134\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.1\u20134\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.16\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\n\u25aa IFS Food 7, Part 2, 4.18.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.18.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.8\n\n\n3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\r\n \r\n\r\n \r\n\n\n\n\u25aa WADA International Standard for Laboratories (ISL) 1.2\n\n3.14 The system shall allow users to link samples, batches, and tests to a specific accreditation approval status (e.g., ANSI National Accreditation Board accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\r\n \r\n\r\n \r\n\n\n\n\n4. Results review and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa ASTM E1578-18 C-4-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa ISO 15189:2012 5.5.1.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-2\r\n\n\u25aa CLSI AUTO15 1.2\n\u25aa EPA ERLN Laboratory Requirements 4.9.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa ISO 15189:2012 5.9.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 C-4-3\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n4.3 The system shall accurately maintain a full audit trail for modified results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa A2LA C211 5.9.1\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa ABFT Accreditation Manual Sec. E-28\u201329\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G15.1\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135\r\n\n\u25aa ASTM E1578-18 C-4-4\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.4\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\r\n\n\u25aa IFS Food 7, Part 2, 5.6.4\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.4\r\n\n\u25aa ISO 15189:2012 5.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.1.1\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10(3)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa USDA Data and Instrumentation for PDP 10\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.1\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1\n\n\n4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\r\n\n\u25aa IFS Food 7, Part 2, 5.6.4\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.4\r\n\n\u25aa ISO 15189:2012 5.9.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-6\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\n\n\n4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI AUTO15 4.0\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n\n\n\n 5. Sample, experiment, and study approval and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 C-5-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.12.1\n\n\n5.1 The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa AIHA-LAP Policies 2022 2A.7.7.2\r\n\n\u25aa ASTM E1578-18 C-5-2\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.160 (b)\r\n\u25aa ASTM E1578-18 C-5-3\r\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6.1\n\n5.3 The system should provide appropriate functions for specific sample statuses like \"approved,\" \"rejected,\" and \"cancelled,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\r\n \r\n\r\n \r\n\n\n\n\n6. Reporting \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 C-6-1\n\n6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\r\n \r\n\r\n \r\n\n\n\n\u25aa EPA ERLN Laboratory Requirements 3.4\r\n\u25aa EPA ERLN Laboratory Requirements 4.1.4\r\n\u25aa EPA ERLN Laboratory Requirements 4.12\u201315\n\n6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1291 (g) and (h)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.2\r\n\n\u25aa ASTM E1578-18 C-6-2\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.4\r\n\n\u25aa EPA QA\/G-5 2.4.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n6.3 The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.\r\n \r\n\r\n \r\n\n\n\n\u25aa ABFT Accreditation Manual Sec. G-2\n\n6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.25\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 42 CFR Part 493.1291 (c\u2013e)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.8.1\r\n\n\u25aa ABFT Accreditation Manual Sec. E-12 and -32\r\n\n\u25aa ASTM E1578-18 C-6-3\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8\r\n\n\u25aa ISO 15189:2012 4.5.2\r\n\n\u25aa ISO 15189:2012 5.8.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.1.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.3.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.43\n\n\n6.5 The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.\r\n \r\n\r\n \r\n\n\n\n\u25aa 7 CFR Part 91.26\u201327\r\n\u25aa 21 CFR Part 1.1152 (d)\r\n\u25aa ASTM E1578-18 C-6-4\n\n6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa A2LA C211 5.10\r\n\n\u25aa ASTM E1578-18 C-6-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.2.3\r\n\n\u25aa ISO 15189:2012 5.8.1\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.5\r\n\n\u25aa 9 CFR Part 121.5\u20136\r\n\n\u25aa 21 CFR Part 1.1110\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 58.185\r\n\n\u25aa 21 CFR Part 312.64\r\n\n\u25aa 21 CFR Part 812.150\r\n\n\u25aa 40 CFR Part 141.31\r\n\n\u25aa 40 CFR Part 141.721\r\n\n\u25aa 40 CFR Part 370 Subpart C\r\n\n\u25aa 40 CFR Part 372 Subpart B\r\n\n\u25aa 40 CFR Part 704\r\n\n\u25aa 40 CFR Part 717 Subpart A\r\n\n\u25aa 40 CFR Part 720.40\r\n\n\u25aa 42 CFR Part 73.5\u20136\r\n\n\u25aa 42 CFR Part 493.43 (d)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories E8\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G17.1\r\n\n\u25aa ASTM E1578-18 C-6-7\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.12\u201315\r\n\n\u25aa EPA QA\/G-5 2.3.2\r\n\n\u25aa IFS Food 7, Part 4, 2.x\r\n\n\u25aa IFS PACsecure 2, Part 4, 1.x\r\n\n\u25aa NIST 800-53, Rev. 5, IR-6 and IR-6(1)\r\n\n\u25aa OECD GLP Principles 9.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.28\r\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 58 Sec. 58.185 (c)\r\n\n\u25aa A2LA C211 5.10.9\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310\r\n\n\u25aa CLSI QMS22 2.2.3.4\r\n\n\u25aa ICH GCP 4.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 9.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)\n\n\n6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n6.10 The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n6.11 The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#5._Sample.2C_experiment.2C_and_study_approval_and_verification\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#5._Sample.2C_experiment.2C_and_study_approval_and_verification<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 23 December 2020, at 19:53.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","3ba7a90aa5cf7c32844e9a2b57c49fb5_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Primary_laboratory_workflow rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Primary_laboratory_workflow skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Primary laboratory workflow<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"1._Sample_and_experiment_registration\">1. Sample and experiment registration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.1<\/b> The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.121\" target=\"_blank\">21 CFR Part 606.121 (c\u2013i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.140\" target=\"_blank\">21 CFR Part 606.140 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e1-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.2<\/b> The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.410\" target=\"_blank\">45 CFR Part 162.410<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.3<\/b> The system shall provide a means to assign unique identifiers such as a U.S. Department of Food and Agriculture unique cultivator identifier to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.4<\/b> The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.18\" target=\"_blank\">40 CFR Part 262.18<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.5<\/b> The system should permit metadata like lot number, field number, client demographics, sampling point, random selection process used, and other cannabis-specific identifiers to be included during registration.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.6<\/b> The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.7<\/b> The system, when applicable, should offer safety information related to a submitted cannabis-related sample upon registration, which is relevant to the lab's location and sample type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.8<\/b> The system should support the creation, use, and configuration of predefined metadata templates, capturing metadata mandated by state and local laws and regulations for various cannabis substrates\/matrices and derivative products, as well as any other ad-hoc, single, and multiple samples.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px;;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.170\" target=\"_blank\">21 CFR Part 211.170<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1242\" target=\"_blank\">42 CFR Part 493.1242<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.7.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6 and 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=P1000PUE.txt\" target=\"_blank\">EPA 815-R-05-004 Supplement 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10\u201311<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.7.1\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.9<\/b> The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.10<\/b> The system should allow for the addition of observations and descriptions to registered samples in the form of free text.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.11<\/b> The system should support the creation of user-definable default sample registration preferences and\/or input screens\u2014including associated measurement units and any other regulation-mandated attributes\u2014based upon the various cannabis substrates\/matrices and derivative products tested, as well as the sample source location and\/or laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.12<\/b> The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual D-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.13<\/b> The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.14<\/b> The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.15<\/b> The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.16<\/b> The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.17<\/b> The system should provide a means to document and associate sample preparation activities such as grinding, homogenization, extraction, filtration, and evaporation with a given sample, batch, method, protocol, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Appendix A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.3\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.8\u20139<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.18<\/b> The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.16\" target=\"_blank\">7 CFR Part 331.16<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.16\" target=\"_blank\">9 CFR Part 121.16<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.16\" target=\"_blank\">42 CFR Part 73.16<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.19<\/b> In the case of regulated samples such as cannabis, the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required shipping information.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.20<\/b> The system shall be able to link various records together based on a record's metadata, including shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, customer, and more.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"2._Sample_management\">2. Sample management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th scope=\"col\" style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.1<\/b> The system shall record and maintain the chain of custody for the laboratory's standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.2<\/b> The system shall record the current and historical storage location for the laboratory's standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.3<\/b> The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.4<\/b> The system shall require the recording of a standard and reagent's first opening date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.5<\/b> The system shall allow only active standards and reagents to be shown as available for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-6<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.6<\/b> The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.7<\/b> The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, lot or batch ID, field number, test method, assigned user, and status.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-8<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.8<\/b> The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.9<\/b> The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.10<\/b> The system shall be able to link test methods and specifications to standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.65\" target=\"_blank\">21 CFR Part 606.65 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.151\" target=\"_blank\">21 CFR Part 606.151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical \u25aa Genetics Laboratories C6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 12.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.22\u201325<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.11<\/b> The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q1ar2-stability-testing-new-drug-substances-and-products\" target=\"_blank\">FDA Q1A(R2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.12<\/b> The system should allow authorized users to create projects and research studies in the system\u2014including, e.g., stability studies\u2014and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"3._Core_laboratory_testing_and_experiments\">3. Core laboratory testing and experiments<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.1<\/b> The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.2<\/b> The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.3<\/b> The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.4<\/b> The system shall be able to check physical, control, and specification limits for an instrument sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.5<\/b> The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.6<\/b> The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.7<\/b> The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-9<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.8<\/b> The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.9<\/b> The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.8.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.10<\/b> The system shall allow users to enter operators such as <, >, +, and - with numeric test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.11<\/b> The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-13<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.12<\/b> The system should effectively alert users upon entry of out-of-specification test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (c\u2013f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.325<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.161<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.202<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G16.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.10<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.1\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.13<\/b> The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.14<\/b> The system shall allow users to link samples, batches, and tests to a specific accreditation approval status (e.g., ANSI National Accreditation Board accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"4._Results_review_and_verification\">4. Results review and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.1<\/b> The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 1.2<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.2<\/b> The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.3<\/b> The system shall accurately maintain a full audit trail for modified results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-28\u201329<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G15.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.4<\/b> The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.5<\/b> The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.6<\/b> The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 4.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.7<\/b> The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span id=\"rdp-ebb-5._Sample,_experiment,_and_study_approval_and_verification\"><\/span><span class=\"mw-headline\" id=\"5._Sample.2C_experiment.2C_and_study_approval_and_verification\">5. Sample, experiment, and study approval and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.12.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.1<\/b> The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.2<\/b> The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-5-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.3<\/b> The system should provide appropriate functions for specific sample statuses like \"approved,\" \"rejected,\" and \"cancelled,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"6._Reporting\">6. Reporting<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.1<\/b> The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.2<\/b> The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (g) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.3<\/b> The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.4<\/b> The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.25\" target=\"_blank\">7 CFR Part 91.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (c\u2013e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-12 and -32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.43<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.5<\/b> The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.26\" target=\"_blank\">7 CFR Part 91.26\u201327<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.6<\/b> The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.7<\/b> The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.5\" target=\"_blank\">7 CFR Part 331.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.5\" target=\"_blank\">9 CFR Part 121.5\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58.185<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.64\" target=\"_blank\">21 CFR Part 312.64<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.150\" target=\"_blank\">21 CFR Part 812.150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.31\" target=\"_blank\">40 CFR Part 141.31<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.721\" target=\"_blank\">40 CFR Part 141.721<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\/subpart-C\" target=\"_blank\">40 CFR Part 370 Subpart C<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\/subpart-B\" target=\"_blank\">40 CFR Part 372 Subpart B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\/subpart-A\" target=\"_blank\">40 CFR Part 717 Subpart A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.40\" target=\"_blank\">40 CFR Part 720.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.5\" target=\"_blank\">42 CFR Part 73.5\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 4, 2.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 4, 1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-6 and IR-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.8<\/b> The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.28\" target=\"_blank\">7 CFR Part 91.28<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58 Sec. 58.185 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.9<\/b> The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.10<\/b> The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.11<\/b> The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184906\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.079 seconds\nReal time usage: 0.089 seconds\nPreprocessor visited node count: 816\/1000000\nPost\u2010expand include size: 90373\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 24.344 1 -total\n 19.01% 4.628 1 Template:LIMSpec_for_Cannabis_Testing\/Sample_and_experiment_registration\n 17.01% 4.141 1 Template:LIMSpec_for_Cannabis_Testing\/Reporting\n 16.00% 3.895 1 Template:LIMSpec_for_Cannabis_Testing\/Sample_management\n 15.75% 3.835 1 Template:LIMSpec_for_Cannabis_Testing\/Results_review_and_verification\n 14.87% 3.621 1 Template:LIMSpec_for_Cannabis_Testing\/Core_laboratory_testing_and_experiments\n 13.86% 3.374 1 Template:LIMSpec_for_Cannabis_Testing\/Sample,_experiment,_and_study_approval_and_verification\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5461-0!canonical and timestamp 20230623184905 and revision id 16306. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#5._Sample.2C_experiment.2C_and_study_approval_and_verification\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#5._Sample.2C_experiment.2C_and_study_approval_and_verification<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","3ba7a90aa5cf7c32844e9a2b57c49fb5_images":[],"3ba7a90aa5cf7c32844e9a2b57c49fb5_timestamp":1687546819,"e28537905dad573e5a44941545b0d7ad_type":"article","e28537905dad573e5a44941545b0d7ad_title":"4. Results review and verification","e28537905dad573e5a44941545b0d7ad_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#4._Results_review_and_verification","e28537905dad573e5a44941545b0d7ad_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Primary laboratory workflowFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.\n\n1. Sample and experiment registration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 1.1149\r\n\u25aa 42 CFR Part 493.1241\r\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\u25aa ASTM E1578-18 C-1-1\n\n1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 58.105 (c)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 21 CFR Part 606.121 (c\u2013i)\r\n\n\u25aa 21 CFR Part 606.140 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e1-6)\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa ABFT Accreditation Manual Sec. D\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1492-11 4.1.1.6\r\n\n\u25aa ASTM E1578-18 C-1-2\r\n\n\u25aa CLSI QMS22 2.2.1.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.2\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 15\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.2.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.2 The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 162.410\r\n\u25aa CJIS Security Policy 5.6.1\n\n1.3 The system shall provide a means to assign unique identifiers such as a U.S. Department of Food and Agriculture unique cultivator identifier to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1241\r\n\u25aa ASTM E1578-18 C-1-3\n\n1.4 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.19\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 40 CFR Part 262.18\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C2.1\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 C-1-4\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.1.3\n\n\n1.5 The system should permit metadata like lot number, field number, client demographics, sampling point, random selection process used, and other cannabis-specific identifiers to be included during registration.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-5\n\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-6\n\n1.7 The system, when applicable, should offer safety information related to a submitted cannabis-related sample upon registration, which is relevant to the lab's location and sample type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-7\n\n1.8 The system should support the creation, use, and configuration of predefined metadata templates, capturing metadata mandated by state and local laws and regulations for various cannabis substrates\/matrices and derivative products, as well as any other ad-hoc, single, and multiple samples.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.19\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.105 (c)\r\n\n\u25aa 21 CFR Part 58.195\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.170\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 312.57 (d)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1105\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa 42 CFR Part 493.1242\r\n\n\u25aa 42 CFR Part 493.1274 (f)\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.7.1.2\r\n\n\u25aa ABFT Accreditation Manual Sec. D\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C2\r\n\n\u25aa ASTM E1578-18 C-1-8\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6 and 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8\r\n\n\u25aa EPA 815-R-05-004 Supplement 1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.10\u201311\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.7.1\u20136\r\n\n\u25aa EPA QA\/G-5 2.2.2 and 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\n\u25aa ISO 15189:2012 5.7.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.3.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13\r\n\n\u25aa USDA Sampling Procedures for PDP 5.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21\n\n\n1.9 The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-1-9\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G1.4\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.5\n\n\n1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-10\n\n1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens\u2014including associated measurement units and any other regulation-mandated attributes\u2014based upon the various cannabis substrates\/matrices and derivative products tested, as well as the sample source location and\/or laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa ASTM E1578-18 C-1-11\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2\n\n\n1.12 The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.107 (c)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.8.2\r\n\n\u25aa ABFT Accreditation Manual D-3\r\n\n\u25aa ASTM E1578-18 C-1-12\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.10\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 15\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.2\r\n\n\u25aa OECD GLP Principles 6.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1.11\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.2.5\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 58.107 (d)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1578-18 C-1-13\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.7\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)\n\n\n1.14 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa ASTM E1578-18 C-1-14\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.6\n\n\n1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C3.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.8.3\r\n\n\u25aa ASTM E1492-11 4.1.1.5\r\n\n\u25aa ASTM E1492-11 4.1.6\r\n\n\u25aa ASTM E1492-11 4.3.3.2\r\n\n\u25aa ASTM E1578-18 C-1-15\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.1.9\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1\n\n\n1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa A2LA C211 5.7\r\n\n\u25aa ASTM E1578-18 C-1-16\r\n\n\u25aa EPA QA\/G-5 2.2.2 and 2.2.3\n\n\n1.17 The system should provide a means to document and associate sample preparation activities such as grinding, homogenization, extraction, filtration, and evaporation with a given sample, batch, method, protocol, etc.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa A2LA C223 5.8\r\n\n\u25aa ABFT Accreditation Manual Sec. D-9\u201310\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1\r\n\n\u25aa ASTM E1578-18 C-1-17\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 12\r\n\n\u25aa EPA 815-R-05-004 Appendix A\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.3\u20135\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.8\u20139\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10(3)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\n\n\n1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\r\n \r\n\r\n \r\n\n\n\n\u25aa 7 CFR Part 331.16\r\n\u25aa 9 CFR Part 121.16\r\n\u25aa 42 CFR Part 73.16\n\n1.19 In the case of regulated samples such as cannabis, the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required shipping information.\r\n \r\n\r\n \r\n\n\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G1.1\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n1.20 The system shall be able to link various records together based on a record's metadata, including shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, customer, and more.\r\n \r\n\r\n \r\n\n\n\n\n2. Sample management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 C-2-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\n\n\n2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-2\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-3\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-4\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.4 The system shall require the recording of a standard and reagent's first opening date.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-5\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.5 The system shall allow only active standards and reagents to be shown as available for use.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-6\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-7\n\n2.7 The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, lot or batch ID, field number, test method, assigned user, and status.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-8\r\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\u25aa ISO\/IEC 17025:2017 7.4.2\n\n2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1492-11 4.2.1\r\n\n\u25aa ASTM E1578-18 C-2-9\r\n\n\u25aa CAP Laboratory Accreditation Manual\n\n\n2.9 The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1\r\n\n\u25aa ASTM E1578-18 C-2-10\n\n\n2.10 The system shall be able to link test methods and specifications to standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1153 (c)\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.166\u20137\r\n\n\u25aa 21 CFR Part 211.194 (e)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 212.61\r\n\n\u25aa 21 CFR Part 212.70 (e)\r\n\n\u25aa 21 CFR Part 225.58\r\n\n\u25aa 21 CFR Part 226.58\r\n\n\u25aa 21 CFR Part 606.65 (c)\r\n\n\u25aa 21 CFR Part 606.151\r\n\n\u25aa A2LA C223 5.9\r\n\n\u25aa ACMG Technical Standards for Clinical \u25aa Genetics Laboratories C6.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa ASTM E1578-18 C-2-11\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.1.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.3.2\r\n\n\u25aa EPA QA\/G-5 2.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.7.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.5\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.7\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 12.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.7\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.22\u201325\n\n\n2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa FDA Q1A(R2)\n\n2.12 The system should allow authorized users to create projects and research studies in the system\u2014including, e.g., stability studies\u2014and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.\r\n \r\n\r\n \r\n\n\n\n\n3. Core laboratory testing and experiments \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 211.84 (d)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1\r\n\n\u25aa ASTM E1578-18 C-3-1\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa ISO 15189:2012 5.3.2.7\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84 (e)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 C-3-2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\u25aa ASTM E1578-18 C-3-3\n\n3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-4\n\n3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-6\n\n3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-7\n\n3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-8\n\n3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-9\n\n3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-10\n\n3.9 The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\r\n \r\n\r\n \r\n\n\n\n\u25aa AIHA-LAP Policies 2018 2A.7.8.2\r\n\u25aa ASTM E1578-18 C-3-11\n\n3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-12\n\n3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1241\r\n\u25aa ASTM E1578-18 C-3-13\r\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\n\n3.12 The system should effectively alert users upon entry of out-of-specification test results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 1.1153 (c)\r\n\n\u25aa 21 CFR Part 106.100 (c\u2013f)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.325\r\n\n\u25aa 21 CFR Part 112.161\r\n\n\u25aa 21 CFR Part 114.100 (a)\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 212.60 (g)\r\n\n\u25aa 21 CFR Part 507.202\r\n\n\u25aa 21 CFR Part 606.160\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G16.1\r\n\n\u25aa A2LA C223 5.10\n\u25aa ASTM E1578-18 C-3-14\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.1.2.3\u20134\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.1\u20134\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.16\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\n\u25aa IFS Food 7, Part 2, 4.18.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.18.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.8\n\n\n3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\r\n \r\n\r\n \r\n\n\n\n\u25aa WADA International Standard for Laboratories (ISL) 1.2\n\n3.14 The system shall allow users to link samples, batches, and tests to a specific accreditation approval status (e.g., ANSI National Accreditation Board accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\r\n \r\n\r\n \r\n\n\n\n\n4. Results review and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa ASTM E1578-18 C-4-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa ISO 15189:2012 5.5.1.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-2\r\n\n\u25aa CLSI AUTO15 1.2\n\u25aa EPA ERLN Laboratory Requirements 4.9.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa ISO 15189:2012 5.9.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 C-4-3\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n4.3 The system shall accurately maintain a full audit trail for modified results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa A2LA C211 5.9.1\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa ABFT Accreditation Manual Sec. E-28\u201329\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G15.1\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135\r\n\n\u25aa ASTM E1578-18 C-4-4\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.4\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\r\n\n\u25aa IFS Food 7, Part 2, 5.6.4\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.4\r\n\n\u25aa ISO 15189:2012 5.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.1.1\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10(3)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa USDA Data and Instrumentation for PDP 10\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.1\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1\n\n\n4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\r\n\n\u25aa IFS Food 7, Part 2, 5.6.4\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.4\r\n\n\u25aa ISO 15189:2012 5.9.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-6\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\n\n\n4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI AUTO15 4.0\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n\n\n\n 5. Sample, experiment, and study approval and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 C-5-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.12.1\n\n\n5.1 The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa AIHA-LAP Policies 2022 2A.7.7.2\r\n\n\u25aa ASTM E1578-18 C-5-2\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.160 (b)\r\n\u25aa ASTM E1578-18 C-5-3\r\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6.1\n\n5.3 The system should provide appropriate functions for specific sample statuses like \"approved,\" \"rejected,\" and \"cancelled,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\r\n \r\n\r\n \r\n\n\n\n\n6. Reporting \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 C-6-1\n\n6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\r\n \r\n\r\n \r\n\n\n\n\u25aa EPA ERLN Laboratory Requirements 3.4\r\n\u25aa EPA ERLN Laboratory Requirements 4.1.4\r\n\u25aa EPA ERLN Laboratory Requirements 4.12\u201315\n\n6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1291 (g) and (h)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.2\r\n\n\u25aa ASTM E1578-18 C-6-2\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.4\r\n\n\u25aa EPA QA\/G-5 2.4.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n6.3 The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.\r\n \r\n\r\n \r\n\n\n\n\u25aa ABFT Accreditation Manual Sec. G-2\n\n6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.25\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 42 CFR Part 493.1291 (c\u2013e)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.8.1\r\n\n\u25aa ABFT Accreditation Manual Sec. E-12 and -32\r\n\n\u25aa ASTM E1578-18 C-6-3\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8\r\n\n\u25aa ISO 15189:2012 4.5.2\r\n\n\u25aa ISO 15189:2012 5.8.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.1.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.3.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.43\n\n\n6.5 The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.\r\n \r\n\r\n \r\n\n\n\n\u25aa 7 CFR Part 91.26\u201327\r\n\u25aa 21 CFR Part 1.1152 (d)\r\n\u25aa ASTM E1578-18 C-6-4\n\n6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa A2LA C211 5.10\r\n\n\u25aa ASTM E1578-18 C-6-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.2.3\r\n\n\u25aa ISO 15189:2012 5.8.1\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.5\r\n\n\u25aa 9 CFR Part 121.5\u20136\r\n\n\u25aa 21 CFR Part 1.1110\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 58.185\r\n\n\u25aa 21 CFR Part 312.64\r\n\n\u25aa 21 CFR Part 812.150\r\n\n\u25aa 40 CFR Part 141.31\r\n\n\u25aa 40 CFR Part 141.721\r\n\n\u25aa 40 CFR Part 370 Subpart C\r\n\n\u25aa 40 CFR Part 372 Subpart B\r\n\n\u25aa 40 CFR Part 704\r\n\n\u25aa 40 CFR Part 717 Subpart A\r\n\n\u25aa 40 CFR Part 720.40\r\n\n\u25aa 42 CFR Part 73.5\u20136\r\n\n\u25aa 42 CFR Part 493.43 (d)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories E8\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G17.1\r\n\n\u25aa ASTM E1578-18 C-6-7\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.12\u201315\r\n\n\u25aa EPA QA\/G-5 2.3.2\r\n\n\u25aa IFS Food 7, Part 4, 2.x\r\n\n\u25aa IFS PACsecure 2, Part 4, 1.x\r\n\n\u25aa NIST 800-53, Rev. 5, IR-6 and IR-6(1)\r\n\n\u25aa OECD GLP Principles 9.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.28\r\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 58 Sec. 58.185 (c)\r\n\n\u25aa A2LA C211 5.10.9\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310\r\n\n\u25aa CLSI QMS22 2.2.3.4\r\n\n\u25aa ICH GCP 4.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 9.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)\n\n\n6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n6.10 The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n6.11 The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#4._Results_review_and_verification\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#4._Results_review_and_verification<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 23 December 2020, at 19:53.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","e28537905dad573e5a44941545b0d7ad_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Primary_laboratory_workflow rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Primary_laboratory_workflow skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Primary laboratory workflow<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"1._Sample_and_experiment_registration\">1. Sample and experiment registration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.1<\/b> The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.121\" target=\"_blank\">21 CFR Part 606.121 (c\u2013i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.140\" target=\"_blank\">21 CFR Part 606.140 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e1-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.2<\/b> The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.410\" target=\"_blank\">45 CFR Part 162.410<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.3<\/b> The system shall provide a means to assign unique identifiers such as a U.S. Department of Food and Agriculture unique cultivator identifier to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.4<\/b> The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.18\" target=\"_blank\">40 CFR Part 262.18<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.5<\/b> The system should permit metadata like lot number, field number, client demographics, sampling point, random selection process used, and other cannabis-specific identifiers to be included during registration.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.6<\/b> The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.7<\/b> The system, when applicable, should offer safety information related to a submitted cannabis-related sample upon registration, which is relevant to the lab's location and sample type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.8<\/b> The system should support the creation, use, and configuration of predefined metadata templates, capturing metadata mandated by state and local laws and regulations for various cannabis substrates\/matrices and derivative products, as well as any other ad-hoc, single, and multiple samples.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px;;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.170\" target=\"_blank\">21 CFR Part 211.170<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1242\" target=\"_blank\">42 CFR Part 493.1242<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.7.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6 and 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=P1000PUE.txt\" target=\"_blank\">EPA 815-R-05-004 Supplement 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10\u201311<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.7.1\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.9<\/b> The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.10<\/b> The system should allow for the addition of observations and descriptions to registered samples in the form of free text.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.11<\/b> The system should support the creation of user-definable default sample registration preferences and\/or input screens\u2014including associated measurement units and any other regulation-mandated attributes\u2014based upon the various cannabis substrates\/matrices and derivative products tested, as well as the sample source location and\/or laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.12<\/b> The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual D-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.13<\/b> The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.14<\/b> The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.15<\/b> The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.16<\/b> The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.17<\/b> The system should provide a means to document and associate sample preparation activities such as grinding, homogenization, extraction, filtration, and evaporation with a given sample, batch, method, protocol, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Appendix A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.3\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.8\u20139<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.18<\/b> The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.16\" target=\"_blank\">7 CFR Part 331.16<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.16\" target=\"_blank\">9 CFR Part 121.16<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.16\" target=\"_blank\">42 CFR Part 73.16<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.19<\/b> In the case of regulated samples such as cannabis, the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required shipping information.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.20<\/b> The system shall be able to link various records together based on a record's metadata, including shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, customer, and more.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"2._Sample_management\">2. Sample management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th scope=\"col\" style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.1<\/b> The system shall record and maintain the chain of custody for the laboratory's standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.2<\/b> The system shall record the current and historical storage location for the laboratory's standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.3<\/b> The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.4<\/b> The system shall require the recording of a standard and reagent's first opening date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.5<\/b> The system shall allow only active standards and reagents to be shown as available for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-6<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.6<\/b> The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.7<\/b> The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, lot or batch ID, field number, test method, assigned user, and status.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-8<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.8<\/b> The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.9<\/b> The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.10<\/b> The system shall be able to link test methods and specifications to standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.65\" target=\"_blank\">21 CFR Part 606.65 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.151\" target=\"_blank\">21 CFR Part 606.151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical \u25aa Genetics Laboratories C6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 12.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.22\u201325<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.11<\/b> The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q1ar2-stability-testing-new-drug-substances-and-products\" target=\"_blank\">FDA Q1A(R2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.12<\/b> The system should allow authorized users to create projects and research studies in the system\u2014including, e.g., stability studies\u2014and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"3._Core_laboratory_testing_and_experiments\">3. Core laboratory testing and experiments<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.1<\/b> The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.2<\/b> The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.3<\/b> The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.4<\/b> The system shall be able to check physical, control, and specification limits for an instrument sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.5<\/b> The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.6<\/b> The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.7<\/b> The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-9<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.8<\/b> The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.9<\/b> The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.8.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.10<\/b> The system shall allow users to enter operators such as <, >, +, and - with numeric test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.11<\/b> The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-13<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.12<\/b> The system should effectively alert users upon entry of out-of-specification test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (c\u2013f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.325<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.161<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.202<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G16.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.10<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.1\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.13<\/b> The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.14<\/b> The system shall allow users to link samples, batches, and tests to a specific accreditation approval status (e.g., ANSI National Accreditation Board accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"4._Results_review_and_verification\">4. Results review and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.1<\/b> The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 1.2<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.2<\/b> The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.3<\/b> The system shall accurately maintain a full audit trail for modified results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-28\u201329<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G15.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.4<\/b> The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.5<\/b> The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.6<\/b> The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 4.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.7<\/b> The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span id=\"rdp-ebb-5._Sample,_experiment,_and_study_approval_and_verification\"><\/span><span class=\"mw-headline\" id=\"5._Sample.2C_experiment.2C_and_study_approval_and_verification\">5. Sample, experiment, and study approval and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.12.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.1<\/b> The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.2<\/b> The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-5-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.3<\/b> The system should provide appropriate functions for specific sample statuses like \"approved,\" \"rejected,\" and \"cancelled,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"6._Reporting\">6. Reporting<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.1<\/b> The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.2<\/b> The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (g) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.3<\/b> The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.4<\/b> The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.25\" target=\"_blank\">7 CFR Part 91.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (c\u2013e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-12 and -32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.43<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.5<\/b> The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.26\" target=\"_blank\">7 CFR Part 91.26\u201327<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.6<\/b> The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.7<\/b> The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.5\" target=\"_blank\">7 CFR Part 331.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.5\" target=\"_blank\">9 CFR Part 121.5\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58.185<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.64\" target=\"_blank\">21 CFR Part 312.64<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.150\" target=\"_blank\">21 CFR Part 812.150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.31\" target=\"_blank\">40 CFR Part 141.31<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.721\" target=\"_blank\">40 CFR Part 141.721<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\/subpart-C\" target=\"_blank\">40 CFR Part 370 Subpart C<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\/subpart-B\" target=\"_blank\">40 CFR Part 372 Subpart B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\/subpart-A\" target=\"_blank\">40 CFR Part 717 Subpart A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.40\" target=\"_blank\">40 CFR Part 720.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.5\" target=\"_blank\">42 CFR Part 73.5\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 4, 2.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 4, 1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-6 and IR-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.8<\/b> The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.28\" target=\"_blank\">7 CFR Part 91.28<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58 Sec. 58.185 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.9<\/b> The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.10<\/b> The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.11<\/b> The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184906\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.079 seconds\nReal time usage: 0.089 seconds\nPreprocessor visited node count: 816\/1000000\nPost\u2010expand include size: 90373\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 24.344 1 -total\n 19.01% 4.628 1 Template:LIMSpec_for_Cannabis_Testing\/Sample_and_experiment_registration\n 17.01% 4.141 1 Template:LIMSpec_for_Cannabis_Testing\/Reporting\n 16.00% 3.895 1 Template:LIMSpec_for_Cannabis_Testing\/Sample_management\n 15.75% 3.835 1 Template:LIMSpec_for_Cannabis_Testing\/Results_review_and_verification\n 14.87% 3.621 1 Template:LIMSpec_for_Cannabis_Testing\/Core_laboratory_testing_and_experiments\n 13.86% 3.374 1 Template:LIMSpec_for_Cannabis_Testing\/Sample,_experiment,_and_study_approval_and_verification\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5461-0!canonical and timestamp 20230623184905 and revision id 16306. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#4._Results_review_and_verification\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#4._Results_review_and_verification<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","e28537905dad573e5a44941545b0d7ad_images":[],"e28537905dad573e5a44941545b0d7ad_timestamp":1687546819,"935a30c09d1fa5a3d603971953db22b8_type":"article","935a30c09d1fa5a3d603971953db22b8_title":"3. Core laboratory testing and experiments","935a30c09d1fa5a3d603971953db22b8_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#3._Core_laboratory_testing_and_experiments","935a30c09d1fa5a3d603971953db22b8_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Primary laboratory workflowFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.\n\n1. Sample and experiment registration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 1.1149\r\n\u25aa 42 CFR Part 493.1241\r\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\u25aa ASTM E1578-18 C-1-1\n\n1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 58.105 (c)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 21 CFR Part 606.121 (c\u2013i)\r\n\n\u25aa 21 CFR Part 606.140 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e1-6)\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa ABFT Accreditation Manual Sec. D\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1492-11 4.1.1.6\r\n\n\u25aa ASTM E1578-18 C-1-2\r\n\n\u25aa CLSI QMS22 2.2.1.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.2\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 15\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.2.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.2 The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 162.410\r\n\u25aa CJIS Security Policy 5.6.1\n\n1.3 The system shall provide a means to assign unique identifiers such as a U.S. Department of Food and Agriculture unique cultivator identifier to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1241\r\n\u25aa ASTM E1578-18 C-1-3\n\n1.4 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.19\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 40 CFR Part 262.18\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C2.1\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 C-1-4\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.1.3\n\n\n1.5 The system should permit metadata like lot number, field number, client demographics, sampling point, random selection process used, and other cannabis-specific identifiers to be included during registration.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-5\n\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-6\n\n1.7 The system, when applicable, should offer safety information related to a submitted cannabis-related sample upon registration, which is relevant to the lab's location and sample type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-7\n\n1.8 The system should support the creation, use, and configuration of predefined metadata templates, capturing metadata mandated by state and local laws and regulations for various cannabis substrates\/matrices and derivative products, as well as any other ad-hoc, single, and multiple samples.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.19\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.105 (c)\r\n\n\u25aa 21 CFR Part 58.195\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.170\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 312.57 (d)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1105\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa 42 CFR Part 493.1242\r\n\n\u25aa 42 CFR Part 493.1274 (f)\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.7.1.2\r\n\n\u25aa ABFT Accreditation Manual Sec. D\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C2\r\n\n\u25aa ASTM E1578-18 C-1-8\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6 and 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8\r\n\n\u25aa EPA 815-R-05-004 Supplement 1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.10\u201311\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.7.1\u20136\r\n\n\u25aa EPA QA\/G-5 2.2.2 and 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\n\u25aa ISO 15189:2012 5.7.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.3.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13\r\n\n\u25aa USDA Sampling Procedures for PDP 5.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21\n\n\n1.9 The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-1-9\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G1.4\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.5\n\n\n1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-10\n\n1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens\u2014including associated measurement units and any other regulation-mandated attributes\u2014based upon the various cannabis substrates\/matrices and derivative products tested, as well as the sample source location and\/or laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa ASTM E1578-18 C-1-11\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2\n\n\n1.12 The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.107 (c)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.8.2\r\n\n\u25aa ABFT Accreditation Manual D-3\r\n\n\u25aa ASTM E1578-18 C-1-12\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.10\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 15\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.2\r\n\n\u25aa OECD GLP Principles 6.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1.11\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.2.5\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 58.107 (d)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1578-18 C-1-13\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.7\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)\n\n\n1.14 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa ASTM E1578-18 C-1-14\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.6\n\n\n1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C3.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.8.3\r\n\n\u25aa ASTM E1492-11 4.1.1.5\r\n\n\u25aa ASTM E1492-11 4.1.6\r\n\n\u25aa ASTM E1492-11 4.3.3.2\r\n\n\u25aa ASTM E1578-18 C-1-15\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.1.9\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1\n\n\n1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa A2LA C211 5.7\r\n\n\u25aa ASTM E1578-18 C-1-16\r\n\n\u25aa EPA QA\/G-5 2.2.2 and 2.2.3\n\n\n1.17 The system should provide a means to document and associate sample preparation activities such as grinding, homogenization, extraction, filtration, and evaporation with a given sample, batch, method, protocol, etc.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa A2LA C223 5.8\r\n\n\u25aa ABFT Accreditation Manual Sec. D-9\u201310\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1\r\n\n\u25aa ASTM E1578-18 C-1-17\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 12\r\n\n\u25aa EPA 815-R-05-004 Appendix A\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.3\u20135\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.8\u20139\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10(3)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\n\n\n1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\r\n \r\n\r\n \r\n\n\n\n\u25aa 7 CFR Part 331.16\r\n\u25aa 9 CFR Part 121.16\r\n\u25aa 42 CFR Part 73.16\n\n1.19 In the case of regulated samples such as cannabis, the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required shipping information.\r\n \r\n\r\n \r\n\n\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G1.1\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n1.20 The system shall be able to link various records together based on a record's metadata, including shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, customer, and more.\r\n \r\n\r\n \r\n\n\n\n\n2. Sample management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 C-2-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\n\n\n2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-2\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-3\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-4\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.4 The system shall require the recording of a standard and reagent's first opening date.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-5\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.5 The system shall allow only active standards and reagents to be shown as available for use.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-6\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-7\n\n2.7 The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, lot or batch ID, field number, test method, assigned user, and status.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-8\r\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\u25aa ISO\/IEC 17025:2017 7.4.2\n\n2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1492-11 4.2.1\r\n\n\u25aa ASTM E1578-18 C-2-9\r\n\n\u25aa CAP Laboratory Accreditation Manual\n\n\n2.9 The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1\r\n\n\u25aa ASTM E1578-18 C-2-10\n\n\n2.10 The system shall be able to link test methods and specifications to standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1153 (c)\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.166\u20137\r\n\n\u25aa 21 CFR Part 211.194 (e)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 212.61\r\n\n\u25aa 21 CFR Part 212.70 (e)\r\n\n\u25aa 21 CFR Part 225.58\r\n\n\u25aa 21 CFR Part 226.58\r\n\n\u25aa 21 CFR Part 606.65 (c)\r\n\n\u25aa 21 CFR Part 606.151\r\n\n\u25aa A2LA C223 5.9\r\n\n\u25aa ACMG Technical Standards for Clinical \u25aa Genetics Laboratories C6.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa ASTM E1578-18 C-2-11\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.1.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.3.2\r\n\n\u25aa EPA QA\/G-5 2.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.7.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.5\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.7\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 12.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.7\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.22\u201325\n\n\n2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa FDA Q1A(R2)\n\n2.12 The system should allow authorized users to create projects and research studies in the system\u2014including, e.g., stability studies\u2014and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.\r\n \r\n\r\n \r\n\n\n\n\n3. Core laboratory testing and experiments \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 211.84 (d)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1\r\n\n\u25aa ASTM E1578-18 C-3-1\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa ISO 15189:2012 5.3.2.7\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84 (e)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 C-3-2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\u25aa ASTM E1578-18 C-3-3\n\n3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-4\n\n3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-6\n\n3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-7\n\n3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-8\n\n3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-9\n\n3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-10\n\n3.9 The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\r\n \r\n\r\n \r\n\n\n\n\u25aa AIHA-LAP Policies 2018 2A.7.8.2\r\n\u25aa ASTM E1578-18 C-3-11\n\n3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-12\n\n3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1241\r\n\u25aa ASTM E1578-18 C-3-13\r\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\n\n3.12 The system should effectively alert users upon entry of out-of-specification test results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 1.1153 (c)\r\n\n\u25aa 21 CFR Part 106.100 (c\u2013f)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.325\r\n\n\u25aa 21 CFR Part 112.161\r\n\n\u25aa 21 CFR Part 114.100 (a)\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 212.60 (g)\r\n\n\u25aa 21 CFR Part 507.202\r\n\n\u25aa 21 CFR Part 606.160\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G16.1\r\n\n\u25aa A2LA C223 5.10\n\u25aa ASTM E1578-18 C-3-14\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.1.2.3\u20134\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.1\u20134\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.16\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\n\u25aa IFS Food 7, Part 2, 4.18.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.18.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.8\n\n\n3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\r\n \r\n\r\n \r\n\n\n\n\u25aa WADA International Standard for Laboratories (ISL) 1.2\n\n3.14 The system shall allow users to link samples, batches, and tests to a specific accreditation approval status (e.g., ANSI National Accreditation Board accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\r\n \r\n\r\n \r\n\n\n\n\n4. Results review and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa ASTM E1578-18 C-4-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa ISO 15189:2012 5.5.1.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-2\r\n\n\u25aa CLSI AUTO15 1.2\n\u25aa EPA ERLN Laboratory Requirements 4.9.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa ISO 15189:2012 5.9.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 C-4-3\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n4.3 The system shall accurately maintain a full audit trail for modified results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa A2LA C211 5.9.1\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa ABFT Accreditation Manual Sec. E-28\u201329\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G15.1\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135\r\n\n\u25aa ASTM E1578-18 C-4-4\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.4\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\r\n\n\u25aa IFS Food 7, Part 2, 5.6.4\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.4\r\n\n\u25aa ISO 15189:2012 5.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.1.1\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10(3)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa USDA Data and Instrumentation for PDP 10\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.1\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1\n\n\n4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\r\n\n\u25aa IFS Food 7, Part 2, 5.6.4\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.4\r\n\n\u25aa ISO 15189:2012 5.9.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-6\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\n\n\n4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI AUTO15 4.0\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n\n\n\n 5. Sample, experiment, and study approval and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 C-5-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.12.1\n\n\n5.1 The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa AIHA-LAP Policies 2022 2A.7.7.2\r\n\n\u25aa ASTM E1578-18 C-5-2\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.160 (b)\r\n\u25aa ASTM E1578-18 C-5-3\r\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6.1\n\n5.3 The system should provide appropriate functions for specific sample statuses like \"approved,\" \"rejected,\" and \"cancelled,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\r\n \r\n\r\n \r\n\n\n\n\n6. Reporting \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 C-6-1\n\n6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\r\n \r\n\r\n \r\n\n\n\n\u25aa EPA ERLN Laboratory Requirements 3.4\r\n\u25aa EPA ERLN Laboratory Requirements 4.1.4\r\n\u25aa EPA ERLN Laboratory Requirements 4.12\u201315\n\n6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1291 (g) and (h)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.2\r\n\n\u25aa ASTM E1578-18 C-6-2\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.4\r\n\n\u25aa EPA QA\/G-5 2.4.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n6.3 The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.\r\n \r\n\r\n \r\n\n\n\n\u25aa ABFT Accreditation Manual Sec. G-2\n\n6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.25\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 42 CFR Part 493.1291 (c\u2013e)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.8.1\r\n\n\u25aa ABFT Accreditation Manual Sec. E-12 and -32\r\n\n\u25aa ASTM E1578-18 C-6-3\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8\r\n\n\u25aa ISO 15189:2012 4.5.2\r\n\n\u25aa ISO 15189:2012 5.8.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.1.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.3.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.43\n\n\n6.5 The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.\r\n \r\n\r\n \r\n\n\n\n\u25aa 7 CFR Part 91.26\u201327\r\n\u25aa 21 CFR Part 1.1152 (d)\r\n\u25aa ASTM E1578-18 C-6-4\n\n6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa A2LA C211 5.10\r\n\n\u25aa ASTM E1578-18 C-6-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.2.3\r\n\n\u25aa ISO 15189:2012 5.8.1\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.5\r\n\n\u25aa 9 CFR Part 121.5\u20136\r\n\n\u25aa 21 CFR Part 1.1110\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 58.185\r\n\n\u25aa 21 CFR Part 312.64\r\n\n\u25aa 21 CFR Part 812.150\r\n\n\u25aa 40 CFR Part 141.31\r\n\n\u25aa 40 CFR Part 141.721\r\n\n\u25aa 40 CFR Part 370 Subpart C\r\n\n\u25aa 40 CFR Part 372 Subpart B\r\n\n\u25aa 40 CFR Part 704\r\n\n\u25aa 40 CFR Part 717 Subpart A\r\n\n\u25aa 40 CFR Part 720.40\r\n\n\u25aa 42 CFR Part 73.5\u20136\r\n\n\u25aa 42 CFR Part 493.43 (d)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories E8\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G17.1\r\n\n\u25aa ASTM E1578-18 C-6-7\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.12\u201315\r\n\n\u25aa EPA QA\/G-5 2.3.2\r\n\n\u25aa IFS Food 7, Part 4, 2.x\r\n\n\u25aa IFS PACsecure 2, Part 4, 1.x\r\n\n\u25aa NIST 800-53, Rev. 5, IR-6 and IR-6(1)\r\n\n\u25aa OECD GLP Principles 9.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.28\r\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 58 Sec. 58.185 (c)\r\n\n\u25aa A2LA C211 5.10.9\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310\r\n\n\u25aa CLSI QMS22 2.2.3.4\r\n\n\u25aa ICH GCP 4.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 9.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)\n\n\n6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n6.10 The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n6.11 The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#3._Core_laboratory_testing_and_experiments\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#3._Core_laboratory_testing_and_experiments<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 23 December 2020, at 19:53.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","935a30c09d1fa5a3d603971953db22b8_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Primary_laboratory_workflow rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Primary_laboratory_workflow skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Primary laboratory workflow<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"1._Sample_and_experiment_registration\">1. Sample and experiment registration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.1<\/b> The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.121\" target=\"_blank\">21 CFR Part 606.121 (c\u2013i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.140\" target=\"_blank\">21 CFR Part 606.140 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e1-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.2<\/b> The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.410\" target=\"_blank\">45 CFR Part 162.410<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.3<\/b> The system shall provide a means to assign unique identifiers such as a U.S. Department of Food and Agriculture unique cultivator identifier to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.4<\/b> The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.18\" target=\"_blank\">40 CFR Part 262.18<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.5<\/b> The system should permit metadata like lot number, field number, client demographics, sampling point, random selection process used, and other cannabis-specific identifiers to be included during registration.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.6<\/b> The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.7<\/b> The system, when applicable, should offer safety information related to a submitted cannabis-related sample upon registration, which is relevant to the lab's location and sample type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.8<\/b> The system should support the creation, use, and configuration of predefined metadata templates, capturing metadata mandated by state and local laws and regulations for various cannabis substrates\/matrices and derivative products, as well as any other ad-hoc, single, and multiple samples.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px;;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.170\" target=\"_blank\">21 CFR Part 211.170<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1242\" target=\"_blank\">42 CFR Part 493.1242<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.7.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6 and 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=P1000PUE.txt\" target=\"_blank\">EPA 815-R-05-004 Supplement 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10\u201311<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.7.1\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.9<\/b> The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.10<\/b> The system should allow for the addition of observations and descriptions to registered samples in the form of free text.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.11<\/b> The system should support the creation of user-definable default sample registration preferences and\/or input screens\u2014including associated measurement units and any other regulation-mandated attributes\u2014based upon the various cannabis substrates\/matrices and derivative products tested, as well as the sample source location and\/or laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.12<\/b> The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual D-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.13<\/b> The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.14<\/b> The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.15<\/b> The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.16<\/b> The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.17<\/b> The system should provide a means to document and associate sample preparation activities such as grinding, homogenization, extraction, filtration, and evaporation with a given sample, batch, method, protocol, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Appendix A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.3\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.8\u20139<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.18<\/b> The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.16\" target=\"_blank\">7 CFR Part 331.16<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.16\" target=\"_blank\">9 CFR Part 121.16<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.16\" target=\"_blank\">42 CFR Part 73.16<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.19<\/b> In the case of regulated samples such as cannabis, the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required shipping information.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.20<\/b> The system shall be able to link various records together based on a record's metadata, including shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, customer, and more.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"2._Sample_management\">2. Sample management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th scope=\"col\" style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.1<\/b> The system shall record and maintain the chain of custody for the laboratory's standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.2<\/b> The system shall record the current and historical storage location for the laboratory's standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.3<\/b> The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.4<\/b> The system shall require the recording of a standard and reagent's first opening date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.5<\/b> The system shall allow only active standards and reagents to be shown as available for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-6<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.6<\/b> The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.7<\/b> The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, lot or batch ID, field number, test method, assigned user, and status.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-8<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.8<\/b> The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.9<\/b> The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.10<\/b> The system shall be able to link test methods and specifications to standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.65\" target=\"_blank\">21 CFR Part 606.65 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.151\" target=\"_blank\">21 CFR Part 606.151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical \u25aa Genetics Laboratories C6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 12.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.22\u201325<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.11<\/b> The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q1ar2-stability-testing-new-drug-substances-and-products\" target=\"_blank\">FDA Q1A(R2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.12<\/b> The system should allow authorized users to create projects and research studies in the system\u2014including, e.g., stability studies\u2014and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"3._Core_laboratory_testing_and_experiments\">3. Core laboratory testing and experiments<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.1<\/b> The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.2<\/b> The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.3<\/b> The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.4<\/b> The system shall be able to check physical, control, and specification limits for an instrument sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.5<\/b> The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.6<\/b> The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.7<\/b> The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-9<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.8<\/b> The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.9<\/b> The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.8.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.10<\/b> The system shall allow users to enter operators such as <, >, +, and - with numeric test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.11<\/b> The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-13<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.12<\/b> The system should effectively alert users upon entry of out-of-specification test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (c\u2013f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.325<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.161<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.202<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G16.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.10<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.1\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.13<\/b> The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.14<\/b> The system shall allow users to link samples, batches, and tests to a specific accreditation approval status (e.g., ANSI National Accreditation Board accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"4._Results_review_and_verification\">4. Results review and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.1<\/b> The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 1.2<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.2<\/b> The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.3<\/b> The system shall accurately maintain a full audit trail for modified results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-28\u201329<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G15.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.4<\/b> The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.5<\/b> The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.6<\/b> The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 4.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.7<\/b> The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span id=\"rdp-ebb-5._Sample,_experiment,_and_study_approval_and_verification\"><\/span><span class=\"mw-headline\" id=\"5._Sample.2C_experiment.2C_and_study_approval_and_verification\">5. Sample, experiment, and study approval and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.12.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.1<\/b> The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.2<\/b> The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-5-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.3<\/b> The system should provide appropriate functions for specific sample statuses like \"approved,\" \"rejected,\" and \"cancelled,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"6._Reporting\">6. Reporting<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.1<\/b> The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.2<\/b> The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (g) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.3<\/b> The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.4<\/b> The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.25\" target=\"_blank\">7 CFR Part 91.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (c\u2013e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-12 and -32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.43<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.5<\/b> The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.26\" target=\"_blank\">7 CFR Part 91.26\u201327<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.6<\/b> The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.7<\/b> The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.5\" target=\"_blank\">7 CFR Part 331.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.5\" target=\"_blank\">9 CFR Part 121.5\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58.185<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.64\" target=\"_blank\">21 CFR Part 312.64<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.150\" target=\"_blank\">21 CFR Part 812.150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.31\" target=\"_blank\">40 CFR Part 141.31<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.721\" target=\"_blank\">40 CFR Part 141.721<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\/subpart-C\" target=\"_blank\">40 CFR Part 370 Subpart C<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\/subpart-B\" target=\"_blank\">40 CFR Part 372 Subpart B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\/subpart-A\" target=\"_blank\">40 CFR Part 717 Subpart A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.40\" target=\"_blank\">40 CFR Part 720.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.5\" target=\"_blank\">42 CFR Part 73.5\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 4, 2.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 4, 1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-6 and IR-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.8<\/b> The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.28\" target=\"_blank\">7 CFR Part 91.28<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58 Sec. 58.185 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.9<\/b> The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.10<\/b> The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.11<\/b> The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184906\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.079 seconds\nReal time usage: 0.089 seconds\nPreprocessor visited node count: 816\/1000000\nPost\u2010expand include size: 90373\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 24.344 1 -total\n 19.01% 4.628 1 Template:LIMSpec_for_Cannabis_Testing\/Sample_and_experiment_registration\n 17.01% 4.141 1 Template:LIMSpec_for_Cannabis_Testing\/Reporting\n 16.00% 3.895 1 Template:LIMSpec_for_Cannabis_Testing\/Sample_management\n 15.75% 3.835 1 Template:LIMSpec_for_Cannabis_Testing\/Results_review_and_verification\n 14.87% 3.621 1 Template:LIMSpec_for_Cannabis_Testing\/Core_laboratory_testing_and_experiments\n 13.86% 3.374 1 Template:LIMSpec_for_Cannabis_Testing\/Sample,_experiment,_and_study_approval_and_verification\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5461-0!canonical and timestamp 20230623184905 and revision id 16306. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#3._Core_laboratory_testing_and_experiments\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#3._Core_laboratory_testing_and_experiments<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","935a30c09d1fa5a3d603971953db22b8_images":[],"935a30c09d1fa5a3d603971953db22b8_timestamp":1687546819,"9e195f180d77773bc2eed3b21453e276_type":"article","9e195f180d77773bc2eed3b21453e276_title":"2. Sample management","9e195f180d77773bc2eed3b21453e276_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#2._Sample_management","9e195f180d77773bc2eed3b21453e276_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Primary laboratory workflowFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.\n\n1. Sample and experiment registration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 1.1149\r\n\u25aa 42 CFR Part 493.1241\r\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\u25aa ASTM E1578-18 C-1-1\n\n1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 58.105 (c)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 21 CFR Part 606.121 (c\u2013i)\r\n\n\u25aa 21 CFR Part 606.140 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e1-6)\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa ABFT Accreditation Manual Sec. D\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1492-11 4.1.1.6\r\n\n\u25aa ASTM E1578-18 C-1-2\r\n\n\u25aa CLSI QMS22 2.2.1.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.2\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 15\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.2.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.2 The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 162.410\r\n\u25aa CJIS Security Policy 5.6.1\n\n1.3 The system shall provide a means to assign unique identifiers such as a U.S. Department of Food and Agriculture unique cultivator identifier to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1241\r\n\u25aa ASTM E1578-18 C-1-3\n\n1.4 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.19\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 40 CFR Part 262.18\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C2.1\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 C-1-4\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.1.3\n\n\n1.5 The system should permit metadata like lot number, field number, client demographics, sampling point, random selection process used, and other cannabis-specific identifiers to be included during registration.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-5\n\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-6\n\n1.7 The system, when applicable, should offer safety information related to a submitted cannabis-related sample upon registration, which is relevant to the lab's location and sample type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-7\n\n1.8 The system should support the creation, use, and configuration of predefined metadata templates, capturing metadata mandated by state and local laws and regulations for various cannabis substrates\/matrices and derivative products, as well as any other ad-hoc, single, and multiple samples.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.19\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.105 (c)\r\n\n\u25aa 21 CFR Part 58.195\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.170\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 312.57 (d)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1105\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa 42 CFR Part 493.1242\r\n\n\u25aa 42 CFR Part 493.1274 (f)\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.7.1.2\r\n\n\u25aa ABFT Accreditation Manual Sec. D\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C2\r\n\n\u25aa ASTM E1578-18 C-1-8\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6 and 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8\r\n\n\u25aa EPA 815-R-05-004 Supplement 1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.10\u201311\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.7.1\u20136\r\n\n\u25aa EPA QA\/G-5 2.2.2 and 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\n\u25aa ISO 15189:2012 5.7.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.3.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13\r\n\n\u25aa USDA Sampling Procedures for PDP 5.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21\n\n\n1.9 The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-1-9\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G1.4\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.5\n\n\n1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-10\n\n1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens\u2014including associated measurement units and any other regulation-mandated attributes\u2014based upon the various cannabis substrates\/matrices and derivative products tested, as well as the sample source location and\/or laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa ASTM E1578-18 C-1-11\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2\n\n\n1.12 The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.107 (c)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.8.2\r\n\n\u25aa ABFT Accreditation Manual D-3\r\n\n\u25aa ASTM E1578-18 C-1-12\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.10\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 15\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.2\r\n\n\u25aa OECD GLP Principles 6.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1.11\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.2.5\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 58.107 (d)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1578-18 C-1-13\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.7\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)\n\n\n1.14 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa ASTM E1578-18 C-1-14\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.6\n\n\n1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C3.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.8.3\r\n\n\u25aa ASTM E1492-11 4.1.1.5\r\n\n\u25aa ASTM E1492-11 4.1.6\r\n\n\u25aa ASTM E1492-11 4.3.3.2\r\n\n\u25aa ASTM E1578-18 C-1-15\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.1.9\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1\n\n\n1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa A2LA C211 5.7\r\n\n\u25aa ASTM E1578-18 C-1-16\r\n\n\u25aa EPA QA\/G-5 2.2.2 and 2.2.3\n\n\n1.17 The system should provide a means to document and associate sample preparation activities such as grinding, homogenization, extraction, filtration, and evaporation with a given sample, batch, method, protocol, etc.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa A2LA C223 5.8\r\n\n\u25aa ABFT Accreditation Manual Sec. D-9\u201310\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1\r\n\n\u25aa ASTM E1578-18 C-1-17\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 12\r\n\n\u25aa EPA 815-R-05-004 Appendix A\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.3\u20135\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.8\u20139\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10(3)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\n\n\n1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\r\n \r\n\r\n \r\n\n\n\n\u25aa 7 CFR Part 331.16\r\n\u25aa 9 CFR Part 121.16\r\n\u25aa 42 CFR Part 73.16\n\n1.19 In the case of regulated samples such as cannabis, the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required shipping information.\r\n \r\n\r\n \r\n\n\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G1.1\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n1.20 The system shall be able to link various records together based on a record's metadata, including shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, customer, and more.\r\n \r\n\r\n \r\n\n\n\n\n2. Sample management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 C-2-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\n\n\n2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-2\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-3\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-4\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.4 The system shall require the recording of a standard and reagent's first opening date.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-5\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.5 The system shall allow only active standards and reagents to be shown as available for use.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-6\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-7\n\n2.7 The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, lot or batch ID, field number, test method, assigned user, and status.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-8\r\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\u25aa ISO\/IEC 17025:2017 7.4.2\n\n2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1492-11 4.2.1\r\n\n\u25aa ASTM E1578-18 C-2-9\r\n\n\u25aa CAP Laboratory Accreditation Manual\n\n\n2.9 The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1\r\n\n\u25aa ASTM E1578-18 C-2-10\n\n\n2.10 The system shall be able to link test methods and specifications to standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1153 (c)\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.166\u20137\r\n\n\u25aa 21 CFR Part 211.194 (e)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 212.61\r\n\n\u25aa 21 CFR Part 212.70 (e)\r\n\n\u25aa 21 CFR Part 225.58\r\n\n\u25aa 21 CFR Part 226.58\r\n\n\u25aa 21 CFR Part 606.65 (c)\r\n\n\u25aa 21 CFR Part 606.151\r\n\n\u25aa A2LA C223 5.9\r\n\n\u25aa ACMG Technical Standards for Clinical \u25aa Genetics Laboratories C6.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa ASTM E1578-18 C-2-11\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.1.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.3.2\r\n\n\u25aa EPA QA\/G-5 2.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.7.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.5\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.7\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 12.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.7\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.22\u201325\n\n\n2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa FDA Q1A(R2)\n\n2.12 The system should allow authorized users to create projects and research studies in the system\u2014including, e.g., stability studies\u2014and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.\r\n \r\n\r\n \r\n\n\n\n\n3. Core laboratory testing and experiments \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 211.84 (d)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1\r\n\n\u25aa ASTM E1578-18 C-3-1\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa ISO 15189:2012 5.3.2.7\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84 (e)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 C-3-2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\u25aa ASTM E1578-18 C-3-3\n\n3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-4\n\n3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-6\n\n3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-7\n\n3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-8\n\n3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-9\n\n3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-10\n\n3.9 The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\r\n \r\n\r\n \r\n\n\n\n\u25aa AIHA-LAP Policies 2018 2A.7.8.2\r\n\u25aa ASTM E1578-18 C-3-11\n\n3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-12\n\n3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1241\r\n\u25aa ASTM E1578-18 C-3-13\r\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\n\n3.12 The system should effectively alert users upon entry of out-of-specification test results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 1.1153 (c)\r\n\n\u25aa 21 CFR Part 106.100 (c\u2013f)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.325\r\n\n\u25aa 21 CFR Part 112.161\r\n\n\u25aa 21 CFR Part 114.100 (a)\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 212.60 (g)\r\n\n\u25aa 21 CFR Part 507.202\r\n\n\u25aa 21 CFR Part 606.160\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G16.1\r\n\n\u25aa A2LA C223 5.10\n\u25aa ASTM E1578-18 C-3-14\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.1.2.3\u20134\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.1\u20134\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.16\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\n\u25aa IFS Food 7, Part 2, 4.18.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.18.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.8\n\n\n3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\r\n \r\n\r\n \r\n\n\n\n\u25aa WADA International Standard for Laboratories (ISL) 1.2\n\n3.14 The system shall allow users to link samples, batches, and tests to a specific accreditation approval status (e.g., ANSI National Accreditation Board accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\r\n \r\n\r\n \r\n\n\n\n\n4. Results review and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa ASTM E1578-18 C-4-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa ISO 15189:2012 5.5.1.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-2\r\n\n\u25aa CLSI AUTO15 1.2\n\u25aa EPA ERLN Laboratory Requirements 4.9.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa ISO 15189:2012 5.9.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 C-4-3\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n4.3 The system shall accurately maintain a full audit trail for modified results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa A2LA C211 5.9.1\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa ABFT Accreditation Manual Sec. E-28\u201329\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G15.1\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135\r\n\n\u25aa ASTM E1578-18 C-4-4\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.4\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\r\n\n\u25aa IFS Food 7, Part 2, 5.6.4\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.4\r\n\n\u25aa ISO 15189:2012 5.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.1.1\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10(3)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa USDA Data and Instrumentation for PDP 10\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.1\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1\n\n\n4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\r\n\n\u25aa IFS Food 7, Part 2, 5.6.4\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.4\r\n\n\u25aa ISO 15189:2012 5.9.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-6\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\n\n\n4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI AUTO15 4.0\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n\n\n\n 5. Sample, experiment, and study approval and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 C-5-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.12.1\n\n\n5.1 The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa AIHA-LAP Policies 2022 2A.7.7.2\r\n\n\u25aa ASTM E1578-18 C-5-2\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.160 (b)\r\n\u25aa ASTM E1578-18 C-5-3\r\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6.1\n\n5.3 The system should provide appropriate functions for specific sample statuses like \"approved,\" \"rejected,\" and \"cancelled,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\r\n \r\n\r\n \r\n\n\n\n\n6. Reporting \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 C-6-1\n\n6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\r\n \r\n\r\n \r\n\n\n\n\u25aa EPA ERLN Laboratory Requirements 3.4\r\n\u25aa EPA ERLN Laboratory Requirements 4.1.4\r\n\u25aa EPA ERLN Laboratory Requirements 4.12\u201315\n\n6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1291 (g) and (h)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.2\r\n\n\u25aa ASTM E1578-18 C-6-2\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.4\r\n\n\u25aa EPA QA\/G-5 2.4.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n6.3 The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.\r\n \r\n\r\n \r\n\n\n\n\u25aa ABFT Accreditation Manual Sec. G-2\n\n6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.25\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 42 CFR Part 493.1291 (c\u2013e)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.8.1\r\n\n\u25aa ABFT Accreditation Manual Sec. E-12 and -32\r\n\n\u25aa ASTM E1578-18 C-6-3\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8\r\n\n\u25aa ISO 15189:2012 4.5.2\r\n\n\u25aa ISO 15189:2012 5.8.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.1.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.3.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.43\n\n\n6.5 The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.\r\n \r\n\r\n \r\n\n\n\n\u25aa 7 CFR Part 91.26\u201327\r\n\u25aa 21 CFR Part 1.1152 (d)\r\n\u25aa ASTM E1578-18 C-6-4\n\n6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa A2LA C211 5.10\r\n\n\u25aa ASTM E1578-18 C-6-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.2.3\r\n\n\u25aa ISO 15189:2012 5.8.1\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.5\r\n\n\u25aa 9 CFR Part 121.5\u20136\r\n\n\u25aa 21 CFR Part 1.1110\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 58.185\r\n\n\u25aa 21 CFR Part 312.64\r\n\n\u25aa 21 CFR Part 812.150\r\n\n\u25aa 40 CFR Part 141.31\r\n\n\u25aa 40 CFR Part 141.721\r\n\n\u25aa 40 CFR Part 370 Subpart C\r\n\n\u25aa 40 CFR Part 372 Subpart B\r\n\n\u25aa 40 CFR Part 704\r\n\n\u25aa 40 CFR Part 717 Subpart A\r\n\n\u25aa 40 CFR Part 720.40\r\n\n\u25aa 42 CFR Part 73.5\u20136\r\n\n\u25aa 42 CFR Part 493.43 (d)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories E8\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G17.1\r\n\n\u25aa ASTM E1578-18 C-6-7\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.12\u201315\r\n\n\u25aa EPA QA\/G-5 2.3.2\r\n\n\u25aa IFS Food 7, Part 4, 2.x\r\n\n\u25aa IFS PACsecure 2, Part 4, 1.x\r\n\n\u25aa NIST 800-53, Rev. 5, IR-6 and IR-6(1)\r\n\n\u25aa OECD GLP Principles 9.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.28\r\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 58 Sec. 58.185 (c)\r\n\n\u25aa A2LA C211 5.10.9\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310\r\n\n\u25aa CLSI QMS22 2.2.3.4\r\n\n\u25aa ICH GCP 4.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 9.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)\n\n\n6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n6.10 The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n6.11 The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#2._Sample_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#2._Sample_management<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 23 December 2020, at 19:53.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","9e195f180d77773bc2eed3b21453e276_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Primary_laboratory_workflow rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Primary_laboratory_workflow skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Primary laboratory workflow<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"1._Sample_and_experiment_registration\">1. Sample and experiment registration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.1<\/b> The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.121\" target=\"_blank\">21 CFR Part 606.121 (c\u2013i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.140\" target=\"_blank\">21 CFR Part 606.140 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e1-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.2<\/b> The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.410\" target=\"_blank\">45 CFR Part 162.410<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.3<\/b> The system shall provide a means to assign unique identifiers such as a U.S. Department of Food and Agriculture unique cultivator identifier to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.4<\/b> The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.18\" target=\"_blank\">40 CFR Part 262.18<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.5<\/b> The system should permit metadata like lot number, field number, client demographics, sampling point, random selection process used, and other cannabis-specific identifiers to be included during registration.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.6<\/b> The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.7<\/b> The system, when applicable, should offer safety information related to a submitted cannabis-related sample upon registration, which is relevant to the lab's location and sample type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.8<\/b> The system should support the creation, use, and configuration of predefined metadata templates, capturing metadata mandated by state and local laws and regulations for various cannabis substrates\/matrices and derivative products, as well as any other ad-hoc, single, and multiple samples.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px;;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.170\" target=\"_blank\">21 CFR Part 211.170<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1242\" target=\"_blank\">42 CFR Part 493.1242<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.7.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6 and 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=P1000PUE.txt\" target=\"_blank\">EPA 815-R-05-004 Supplement 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10\u201311<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.7.1\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.9<\/b> The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.10<\/b> The system should allow for the addition of observations and descriptions to registered samples in the form of free text.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.11<\/b> The system should support the creation of user-definable default sample registration preferences and\/or input screens\u2014including associated measurement units and any other regulation-mandated attributes\u2014based upon the various cannabis substrates\/matrices and derivative products tested, as well as the sample source location and\/or laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.12<\/b> The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual D-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.13<\/b> The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.14<\/b> The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.15<\/b> The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.16<\/b> The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.17<\/b> The system should provide a means to document and associate sample preparation activities such as grinding, homogenization, extraction, filtration, and evaporation with a given sample, batch, method, protocol, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Appendix A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.3\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.8\u20139<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.18<\/b> The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.16\" target=\"_blank\">7 CFR Part 331.16<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.16\" target=\"_blank\">9 CFR Part 121.16<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.16\" target=\"_blank\">42 CFR Part 73.16<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.19<\/b> In the case of regulated samples such as cannabis, the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required shipping information.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.20<\/b> The system shall be able to link various records together based on a record's metadata, including shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, customer, and more.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"2._Sample_management\">2. Sample management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th scope=\"col\" style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.1<\/b> The system shall record and maintain the chain of custody for the laboratory's standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.2<\/b> The system shall record the current and historical storage location for the laboratory's standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.3<\/b> The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.4<\/b> The system shall require the recording of a standard and reagent's first opening date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.5<\/b> The system shall allow only active standards and reagents to be shown as available for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-6<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.6<\/b> The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.7<\/b> The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, lot or batch ID, field number, test method, assigned user, and status.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-8<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.8<\/b> The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.9<\/b> The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.10<\/b> The system shall be able to link test methods and specifications to standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.65\" target=\"_blank\">21 CFR Part 606.65 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.151\" target=\"_blank\">21 CFR Part 606.151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical \u25aa Genetics Laboratories C6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 12.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.22\u201325<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.11<\/b> The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q1ar2-stability-testing-new-drug-substances-and-products\" target=\"_blank\">FDA Q1A(R2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.12<\/b> The system should allow authorized users to create projects and research studies in the system\u2014including, e.g., stability studies\u2014and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"3._Core_laboratory_testing_and_experiments\">3. Core laboratory testing and experiments<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.1<\/b> The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.2<\/b> The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.3<\/b> The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.4<\/b> The system shall be able to check physical, control, and specification limits for an instrument sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.5<\/b> The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.6<\/b> The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.7<\/b> The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-9<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.8<\/b> The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.9<\/b> The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.8.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.10<\/b> The system shall allow users to enter operators such as <, >, +, and - with numeric test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.11<\/b> The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-13<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.12<\/b> The system should effectively alert users upon entry of out-of-specification test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (c\u2013f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.325<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.161<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.202<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G16.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.10<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.1\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.13<\/b> The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.14<\/b> The system shall allow users to link samples, batches, and tests to a specific accreditation approval status (e.g., ANSI National Accreditation Board accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"4._Results_review_and_verification\">4. Results review and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.1<\/b> The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 1.2<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.2<\/b> The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.3<\/b> The system shall accurately maintain a full audit trail for modified results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-28\u201329<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G15.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.4<\/b> The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.5<\/b> The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.6<\/b> The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 4.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.7<\/b> The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span id=\"rdp-ebb-5._Sample,_experiment,_and_study_approval_and_verification\"><\/span><span class=\"mw-headline\" id=\"5._Sample.2C_experiment.2C_and_study_approval_and_verification\">5. Sample, experiment, and study approval and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.12.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.1<\/b> The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.2<\/b> The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-5-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.3<\/b> The system should provide appropriate functions for specific sample statuses like \"approved,\" \"rejected,\" and \"cancelled,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"6._Reporting\">6. Reporting<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.1<\/b> The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.2<\/b> The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (g) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.3<\/b> The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.4<\/b> The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.25\" target=\"_blank\">7 CFR Part 91.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (c\u2013e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-12 and -32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.43<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.5<\/b> The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.26\" target=\"_blank\">7 CFR Part 91.26\u201327<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.6<\/b> The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.7<\/b> The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.5\" target=\"_blank\">7 CFR Part 331.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.5\" target=\"_blank\">9 CFR Part 121.5\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58.185<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.64\" target=\"_blank\">21 CFR Part 312.64<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.150\" target=\"_blank\">21 CFR Part 812.150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.31\" target=\"_blank\">40 CFR Part 141.31<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.721\" target=\"_blank\">40 CFR Part 141.721<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\/subpart-C\" target=\"_blank\">40 CFR Part 370 Subpart C<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\/subpart-B\" target=\"_blank\">40 CFR Part 372 Subpart B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\/subpart-A\" target=\"_blank\">40 CFR Part 717 Subpart A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.40\" target=\"_blank\">40 CFR Part 720.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.5\" target=\"_blank\">42 CFR Part 73.5\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 4, 2.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 4, 1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-6 and IR-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.8<\/b> The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.28\" target=\"_blank\">7 CFR Part 91.28<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58 Sec. 58.185 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.9<\/b> The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.10<\/b> The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.11<\/b> The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184906\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.079 seconds\nReal time usage: 0.089 seconds\nPreprocessor visited node count: 816\/1000000\nPost\u2010expand include size: 90373\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 24.344 1 -total\n 19.01% 4.628 1 Template:LIMSpec_for_Cannabis_Testing\/Sample_and_experiment_registration\n 17.01% 4.141 1 Template:LIMSpec_for_Cannabis_Testing\/Reporting\n 16.00% 3.895 1 Template:LIMSpec_for_Cannabis_Testing\/Sample_management\n 15.75% 3.835 1 Template:LIMSpec_for_Cannabis_Testing\/Results_review_and_verification\n 14.87% 3.621 1 Template:LIMSpec_for_Cannabis_Testing\/Core_laboratory_testing_and_experiments\n 13.86% 3.374 1 Template:LIMSpec_for_Cannabis_Testing\/Sample,_experiment,_and_study_approval_and_verification\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5461-0!canonical and timestamp 20230623184905 and revision id 16306. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#2._Sample_management\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#2._Sample_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","9e195f180d77773bc2eed3b21453e276_images":[],"9e195f180d77773bc2eed3b21453e276_timestamp":1687546819,"84a636c15976284c4f167d582de08e80_type":"article","84a636c15976284c4f167d582de08e80_title":"1. Sample and experiment registration","84a636c15976284c4f167d582de08e80_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#1._Sample_and_experiment_registration","84a636c15976284c4f167d582de08e80_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Primary laboratory workflowFrom CannaQAWikiJump to navigationJump to search\r\n\nNote: These categories cover what ASTM E1578-18 considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.\n\n1. Sample and experiment registration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa 21 CFR Part 1.1149\r\n\u25aa 42 CFR Part 493.1241\r\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\u25aa ASTM E1578-18 C-1-1\n\n1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 58.105 (c)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.101\r\n\n\u25aa 21 CFR Part 226.80\r\n\n\u25aa 21 CFR Part 606.120 (b)\r\n\n\u25aa 21 CFR Part 606.121 (c\u2013i)\r\n\n\u25aa 21 CFR Part 606.140 (c)\r\n\n\u25aa 29 CFR Part 1910.1030 (g)\r\n\n\u25aa 29 CFR Part 1910.1096 (e1-6)\r\n\n\u25aa 42 CFR Part 493.1232\r\n\n\u25aa ABFT Accreditation Manual Sec. D\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1492-11 4.1.1.6\r\n\n\u25aa ASTM E1578-18 C-1-2\r\n\n\u25aa CLSI QMS22 2.2.1.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.2\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 15\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.2.6\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.2 The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.\r\n \r\n\r\n \r\n\n\n\n\u25aa 45 CFR Part 162.410\r\n\u25aa CJIS Security Policy 5.6.1\n\n1.3 The system shall provide a means to assign unique identifiers such as a U.S. Department of Food and Agriculture unique cultivator identifier to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1241\r\n\u25aa ASTM E1578-18 C-1-3\n\n1.4 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.19\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 40 CFR Part 262.18\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C2.1\r\n\n\u25aa APHL 2019 LIS Project Management Guidebook\r\n\n\u25aa ASTM E1578-18 C-1-4\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.1.3\n\n\n1.5 The system should permit metadata like lot number, field number, client demographics, sampling point, random selection process used, and other cannabis-specific identifiers to be included during registration.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-5\n\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-6\n\n1.7 The system, when applicable, should offer safety information related to a submitted cannabis-related sample upon registration, which is relevant to the lab's location and sample type.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-7\n\n1.8 The system should support the creation, use, and configuration of predefined metadata templates, capturing metadata mandated by state and local laws and regulations for various cannabis substrates\/matrices and derivative products, as well as any other ad-hoc, single, and multiple samples.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.19\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.105 (c)\r\n\n\u25aa 21 CFR Part 58.195\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.170\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 312.57 (d)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1105\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa 42 CFR Part 493.1242\r\n\n\u25aa 42 CFR Part 493.1274 (f)\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.7.1.2\r\n\n\u25aa ABFT Accreditation Manual Sec. D\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C2\r\n\n\u25aa ASTM E1578-18 C-1-8\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6 and 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8\r\n\n\u25aa EPA 815-R-05-004 Supplement 1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.10\u201311\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.7.1\u20136\r\n\n\u25aa EPA QA\/G-5 2.2.2 and 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\n\u25aa ISO 15189:2012 5.7.2\r\n\n\u25aa ISO\/IEC 17025:2017 7.3.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13\r\n\n\u25aa USDA Sampling Procedures for PDP 5.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21\n\n\n1.9 The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-1-9\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G1.4\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.5\n\n\n1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-1-10\n\n1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens\u2014including associated measurement units and any other regulation-mandated attributes\u2014based upon the various cannabis substrates\/matrices and derivative products tested, as well as the sample source location and\/or laboratory location.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa ASTM E1578-18 C-1-11\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2\n\n\n1.12 The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 58.107 (c)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa 42 CFR Part 493.1283\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.8.2\r\n\n\u25aa ABFT Accreditation Manual D-3\r\n\n\u25aa ASTM E1578-18 C-1-12\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.10\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 15\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.2\r\n\n\u25aa OECD GLP Principles 6.2\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1.11\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.2.5\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 58.107 (d)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1578-18 C-1-13\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.7\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa OECD GLP Principles 6.1\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)\n\n\n1.14 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa ASTM E1578-18 C-1-14\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.6\n\n\n1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C3.3\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.8.3\r\n\n\u25aa ASTM E1492-11 4.1.1.5\r\n\n\u25aa ASTM E1492-11 4.1.6\r\n\n\u25aa ASTM E1492-11 4.3.3.2\r\n\n\u25aa ASTM E1578-18 C-1-15\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.3\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.8\r\n\n\u25aa ISO\/IEC 17025:2017 7.4.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137\r\n\n\u25aa USDA Sampling Procedures for PDP 6.4.1.1.9\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1\n\n\n1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa A2LA C211 5.7\r\n\n\u25aa ASTM E1578-18 C-1-16\r\n\n\u25aa EPA QA\/G-5 2.2.2 and 2.2.3\n\n\n1.17 The system should provide a means to document and associate sample preparation activities such as grinding, homogenization, extraction, filtration, and evaporation with a given sample, batch, method, protocol, etc.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.11\r\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.11\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 1.1149\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 42 CFR Part 73.11\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa 42 CFR Part 493.1274\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa A2LA C223 5.8\r\n\n\u25aa ABFT Accreditation Manual Sec. D-9\u201310\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1\r\n\n\u25aa ASTM E1578-18 C-1-17\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa EPA 815-R-05-004 Chap. III, Sec. 12\r\n\n\u25aa EPA 815-R-05-004 Appendix A\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.3\u20135\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.1.13\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.4.8\u20139\r\n\n\u25aa EPA QA\/G-5 2.2.3\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\n\u25aa GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10(3)\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) (throughout)\n\n\n1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\r\n \r\n\r\n \r\n\n\n\n\u25aa 7 CFR Part 331.16\r\n\u25aa 9 CFR Part 121.16\r\n\u25aa 42 CFR Part 73.16\n\n1.19 In the case of regulated samples such as cannabis, the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required shipping information.\r\n \r\n\r\n \r\n\n\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G1.1\r\n\u25aa APHL 2019 LIS Project Management Guidebook\n\n1.20 The system shall be able to link various records together based on a record's metadata, including shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, customer, and more.\r\n \r\n\r\n \r\n\n\n\n\n2. Sample management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 C-2-1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\n\n\n2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-2\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-3\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-4\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.4 The system shall require the recording of a standard and reagent's first opening date.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-5\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.5 The system shall allow only active standards and reagents to be shown as available for use.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-6\r\n\u25aa EPA ERLN Laboratory Requirements 4.11.14\n\n2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-7\n\n2.7 The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, lot or batch ID, field number, test method, assigned user, and status.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-2-8\r\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\u25aa ISO\/IEC 17025:2017 7.4.2\n\n2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.17\r\n\n\u25aa 9 CFR Part 121.17\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 42 CFR Part 73.17\r\n\n\u25aa ASTM E1492-11 4.2.1\r\n\n\u25aa ASTM E1578-18 C-2-9\r\n\n\u25aa CAP Laboratory Accreditation Manual\n\n\n2.9 The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa A2LA C211 5.4\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1\r\n\n\u25aa ASTM E1578-18 C-2-10\n\n\n2.10 The system shall be able to link test methods and specifications to standards and reagents.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1138\r\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1153 (c)\r\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.84\r\n\n\u25aa 21 CFR Part 211.166\u20137\r\n\n\u25aa 21 CFR Part 211.194 (e)\r\n\n\u25aa 21 CFR Part 212.40 (c)\r\n\n\u25aa 21 CFR Part 212.61\r\n\n\u25aa 21 CFR Part 212.70 (e)\r\n\n\u25aa 21 CFR Part 225.58\r\n\n\u25aa 21 CFR Part 226.58\r\n\n\u25aa 21 CFR Part 606.65 (c)\r\n\n\u25aa 21 CFR Part 606.151\r\n\n\u25aa A2LA C223 5.9\r\n\n\u25aa ACMG Technical Standards for Clinical \u25aa Genetics Laboratories C6.2\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa ASTM E1578-18 C-2-11\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.1.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.3.2\r\n\n\u25aa EPA QA\/G-5 2.2.5\r\n\n\u25aa ISO\/IEC 17025:2017 7.7.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa NYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)\r\n\n\u25aa USDA Administrative Procedures for the PDP 8.5\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.7\r\n\n\u25aa WHO Technical Report Series, #961, Annex 13, 12.1\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.7\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 17.22\u201325\n\n\n2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa FDA Q1A(R2)\n\n2.12 The system should allow authorized users to create projects and research studies in the system\u2014including, e.g., stability studies\u2014and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.\r\n \r\n\r\n \r\n\n\n\n\n3. Core laboratory testing and experiments \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 111.315\r\n\n\u25aa 21 CFR Part 211.84 (d)\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1\r\n\n\u25aa ASTM E1578-18 C-3-1\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa ISO 15189:2012 5.3.2.7\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.84 (e)\r\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\n\u25aa ASTM E1578-18 C-3-2\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1252 (d)\r\n\u25aa ASTM E1578-18 C-3-3\n\n3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-4\n\n3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-6\n\n3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-7\n\n3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-8\n\n3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-9\n\n3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-10\n\n3.9 The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\r\n \r\n\r\n \r\n\n\n\n\u25aa AIHA-LAP Policies 2018 2A.7.8.2\r\n\u25aa ASTM E1578-18 C-3-11\n\n3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\r\n \r\n\r\n \r\n\n\n\n\u25aa ASTM E1578-18 C-3-12\n\n3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\r\n \r\n\r\n \r\n\n\n\n\u25aa 42 CFR Part 493.1241\r\n\u25aa ASTM E1578-18 C-3-13\r\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\n\n3.12 The system should effectively alert users upon entry of out-of-specification test results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1150\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 21 CFR Part 1.1153 (c)\r\n\n\u25aa 21 CFR Part 106.100 (c\u2013f)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 111.325\r\n\n\u25aa 21 CFR Part 112.161\r\n\n\u25aa 21 CFR Part 114.100 (a)\r\n\n\u25aa 21 CFR Part 129.80 (g)\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 21 CFR Part 212.60 (g)\r\n\n\u25aa 21 CFR Part 507.202\r\n\n\u25aa 21 CFR Part 606.160\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G16.1\r\n\n\u25aa A2LA C223 5.10\n\u25aa ASTM E1578-18 C-3-14\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.1\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.1.2\r\n\n\u25aa CLSI QMS22 2.2.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.1.2.3\u20134\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.3.4\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.8.1\u20134\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.16\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\n\u25aa E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\n\u25aa IFS Food 7, Part 2, 4.18.3\r\n\n\u25aa IFS PACsecure 2, Part 2, 4.18.3\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6\r\n\n\u25aa SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6\r\n\n\u25aa SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6\r\n\n\u25aa USDA Data and Instrumentation for PDP 5.4.2\r\n\n\u25aa USDA Data and Instrumentation for PDP 8.1.3\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.8\n\n\n3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\r\n \r\n\r\n \r\n\n\n\n\u25aa WADA International Standard for Laboratories (ISL) 1.2\n\n3.14 The system shall allow users to link samples, batches, and tests to a specific accreditation approval status (e.g., ANSI National Accreditation Board accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\r\n \r\n\r\n \r\n\n\n\n\n4. Results review and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa 42 CFR Part 493.1241\r\n\n\u25aa ASTM E1578-18 C-4-1\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.1.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa ISO 15189:2012 5.5.1.4\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-2\r\n\n\u25aa CLSI AUTO15 1.2\n\u25aa EPA ERLN Laboratory Requirements 4.9.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa ISO 15189:2012 5.9.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 211.68\r\n\n\u25aa 21 CFR Part 211.100\r\n\n\u25aa 21 CFR Part 211.160 (a)\r\n\n\u25aa 21 CFR Part 211.188\r\n\n\u25aa 21 CFR Part 211.194\r\n\n\u25aa 45 CFR Part 170.315 (d)\r\n\n\u25aa ASTM E1578-18 C-4-3\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.4.1.1\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\n\u25aa E.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\n\u25aa ICH GCP 4.9.0 and 4.9.3\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n4.3 The system shall accurately maintain a full audit trail for modified results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 21 CFR Part 1.1152 (c)\r\n\n\u25aa 21 CFR Part 111.110\r\n\n\u25aa 21 CFR Part 211.68 (b)\r\n\n\u25aa A2LA C211 5.9.1\r\n\n\u25aa A2LA C223 4.13\r\n\n\u25aa ABFT Accreditation Manual Sec. E-28\u201329\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G15.1\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\n\u25aa ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135\r\n\n\u25aa ASTM E1578-18 C-4-4\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EPA ERLN Laboratory Requirements 3.2.6\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.4\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\r\n\n\u25aa IFS Food 7, Part 2, 5.6.4\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.4\r\n\n\u25aa ISO 15189:2012 5.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 6.2.6\r\n\n\u25aa ISO\/IEC 17025:2017 7.7.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.1.1\r\n\n\u25aa NIST 800-53, Rev. 5, AU-10(3)\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa USDA Data and Instrumentation for PDP 10\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.1\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1\n\n\n4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.4\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.2.5\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.9.11\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\r\n\n\u25aa IFS Food 7, Part 2, 5.6.4\r\n\n\u25aa IFS PACsecure 2, Part 2, 5.6.4\r\n\n\u25aa ISO 15189:2012 5.9.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa ASTM E1578-18 C-4-6\r\n\n\u25aa EPA QA\/G-5 2.2.10\r\n\n\u25aa EPA QA\/G-5 2.4.1\r\n\n\u25aa E.U. Annex 11-6\n\n\n4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI AUTO15 4.0\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n\n\n\n 5. Sample, experiment, and study approval and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n\u25aa ASTM E1578-18 C-5-1\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CLSI QMS22 2.2.3.5\r\n\n\u25aa USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.12.1\n\n\n5.1 The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa AIHA-LAP Policies 2022 2A.7.7.2\r\n\n\u25aa ASTM E1578-18 C-5-2\r\n\n\u25aa CLSI QMS22 2.2.2.2\r\n\n\u25aa EMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\n\u25aa WHO Technical Report Series, #996, Annex 5, 4.12\n\n\n5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\r\n \r\n\r\n \r\n\n\n\n\u25aa 21 CFR Part 211.160 (b)\r\n\u25aa ASTM E1578-18 C-5-3\r\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6.1\n\n5.3 The system should provide appropriate functions for specific sample statuses like \"approved,\" \"rejected,\" and \"cancelled,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\r\n \r\n\r\n \r\n\n\n\n\n6. Reporting \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\u25aa ASTM E1578-18 C-6-1\n\n6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\r\n \r\n\r\n \r\n\n\n\n\u25aa EPA ERLN Laboratory Requirements 3.4\r\n\u25aa EPA ERLN Laboratory Requirements 4.1.4\r\n\u25aa EPA ERLN Laboratory Requirements 4.12\u201315\n\n6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 42 CFR Part 493.1291 (g) and (h)\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories F7.2\r\n\n\u25aa ASTM E1578-18 C-6-2\r\n\n\u25aa CLSI QMS22 2.1.2.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.11.4\r\n\n\u25aa EPA QA\/G-5 2.4.2\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n6.3 The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.\r\n \r\n\r\n \r\n\n\n\n\u25aa ABFT Accreditation Manual Sec. G-2\n\n6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.25\r\n\n\u25aa 21 CFR Part 1.1152 (d)\r\n\n\u25aa 40 CFR Part 141.33\r\n\n\u25aa 42 CFR Part 493.1291 (c\u2013e)\r\n\n\u25aa AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.4.2.1\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135\r\n\n\u25aa AIHA-LAP Policies 2022 2A.7.8.1\r\n\n\u25aa ABFT Accreditation Manual Sec. E-12 and -32\r\n\n\u25aa ASTM E1578-18 C-6-3\r\n\n\u25aa EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8\r\n\n\u25aa EPA 815-R-05-004 Chap. VI, Sec. 8\r\n\n\u25aa ISO 15189:2012 4.5.2\r\n\n\u25aa ISO 15189:2012 5.8.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.5.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.1.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.2.1\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.3.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d\r\n\n\u25aa WHO Technical Report Series, #986, Annex 2, 15.43\n\n\n6.5 The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.\r\n \r\n\r\n \r\n\n\n\n\u25aa 7 CFR Part 91.26\u201327\r\n\u25aa 21 CFR Part 1.1152 (d)\r\n\u25aa ASTM E1578-18 C-6-4\n\n6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa A2LA C211 5.10\r\n\n\u25aa ASTM E1578-18 C-6-5\r\n\n\u25aa BRC GSFS, Issue 8, 5.6.1.2\r\n\n\u25aa BRC GSFS, Issue 8, 9.3.5\r\n\n\u25aa CLSI QMS22 2.2.3\r\n\n\u25aa ISO 15189:2012 5.8.1\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)\r\n\n\u25aa USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 331.5\r\n\n\u25aa 9 CFR Part 121.5\u20136\r\n\n\u25aa 21 CFR Part 1.1110\r\n\n\u25aa 21 CFR Part 1.1152 (a\u2013b)\r\n\n\u25aa 21 CFR Part 58.185\r\n\n\u25aa 21 CFR Part 312.64\r\n\n\u25aa 21 CFR Part 812.150\r\n\n\u25aa 40 CFR Part 141.31\r\n\n\u25aa 40 CFR Part 141.721\r\n\n\u25aa 40 CFR Part 370 Subpart C\r\n\n\u25aa 40 CFR Part 372 Subpart B\r\n\n\u25aa 40 CFR Part 704\r\n\n\u25aa 40 CFR Part 717 Subpart A\r\n\n\u25aa 40 CFR Part 720.40\r\n\n\u25aa 42 CFR Part 73.5\u20136\r\n\n\u25aa 42 CFR Part 493.43 (d)\r\n\n\u25aa ABFT Accreditation Manual Sec. E-7\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories E8\r\n\n\u25aa ACMG Technical Standards for Clinical Genetics Laboratories G17.1\r\n\n\u25aa ASTM E1578-18 C-6-7\r\n\n\u25aa CAP Laboratory Accreditation Manual\r\n\n\u25aa CJIS Security Policy 5.3.1\r\n\n\u25aa EPA ERLN Laboratory Requirements 4.12\u201315\r\n\n\u25aa EPA QA\/G-5 2.3.2\r\n\n\u25aa IFS Food 7, Part 4, 2.x\r\n\n\u25aa IFS PACsecure 2, Part 4, 1.x\r\n\n\u25aa NIST 800-53, Rev. 5, IR-6 and IR-6(1)\r\n\n\u25aa OECD GLP Principles 9.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (throughout)\r\n\n\u25aa USDA Administrative Procedures for the PDP (throughout)\r\n\n\u25aa WADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\r\n \r\n\r\n \r\n\n\n\n\n\u25aa 7 CFR Part 91.28\r\n\n\u25aa 21 CFR Part 1.1154 (c)\r\n\n\u25aa 21 CFR Part 58 Sec. 58.185 (c)\r\n\n\u25aa A2LA C211 5.10.9\r\n\n\u25aa AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310\r\n\n\u25aa CLSI QMS22 2.2.3.4\r\n\n\u25aa ICH GCP 4.9.3\r\n\n\u25aa ISO\/IEC 17025:2017 7.8.8\r\n\n\u25aa NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\u25aa OECD GLP Principles 9.1\r\n\n\u25aa PFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\n\u25aa TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)\n\n\n6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n6.10 The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis.\r\n \r\n\r\n \r\n\n\n\n\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n\n6.11 The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis.\r\n \r\n\r\n \r\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#1._Sample_and_experiment_registration\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#1._Sample_and_experiment_registration<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 23 December 2020, at 19:53.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","84a636c15976284c4f167d582de08e80_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Primary_laboratory_workflow rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Primary_laboratory_workflow skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Primary laboratory workflow<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p><br \/>\n<b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.<\/b>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"1._Sample_and_experiment_registration\">1. Sample and experiment registration<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.1<\/b> The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.121\" target=\"_blank\">21 CFR Part 606.121 (c\u2013i)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.140\" target=\"_blank\">21 CFR Part 606.140 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e1-6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.2<\/b> The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.410\" target=\"_blank\">45 CFR Part 162.410<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.3<\/b> The system shall provide a means to assign unique identifiers such as a U.S. Department of Food and Agriculture unique cultivator identifier to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.4<\/b> The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.18\" target=\"_blank\">40 CFR Part 262.18<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.5<\/b> The system should permit metadata like lot number, field number, client demographics, sampling point, random selection process used, and other cannabis-specific identifiers to be included during registration.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-5<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.6<\/b> The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.7<\/b> The system, when applicable, should offer safety information related to a submitted cannabis-related sample upon registration, which is relevant to the lab's location and sample type.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.8<\/b> The system should support the creation, use, and configuration of predefined metadata templates, capturing metadata mandated by state and local laws and regulations for various cannabis substrates\/matrices and derivative products, as well as any other ad-hoc, single, and multiple samples.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px;;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.170\" target=\"_blank\">21 CFR Part 211.170<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1242\" target=\"_blank\">42 CFR Part 493.1242<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.7.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6 and 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=P1000PUE.txt\" target=\"_blank\">EPA 815-R-05-004 Supplement 1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10\u201311<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.7.1\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.9<\/b> The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.10<\/b> The system should allow for the addition of observations and descriptions to registered samples in the form of free text.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.11<\/b> The system should support the creation of user-definable default sample registration preferences and\/or input screens\u2014including associated measurement units and any other regulation-mandated attributes\u2014based upon the various cannabis substrates\/matrices and derivative products tested, as well as the sample source location and\/or laboratory location.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.12<\/b> The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual D-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.13<\/b> The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.14<\/b> The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.15<\/b> The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C3.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-15<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.16<\/b> The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.17<\/b> The system should provide a means to document and associate sample preparation activities such as grinding, homogenization, extraction, filtration, and evaporation with a given sample, batch, method, protocol, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Appendix A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.3\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.8\u20139<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.18<\/b> The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.16\" target=\"_blank\">7 CFR Part 331.16<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.16\" target=\"_blank\">9 CFR Part 121.16<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.16\" target=\"_blank\">42 CFR Part 73.16<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>1.19<\/b> In the case of regulated samples such as cannabis, the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required shipping information.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.1<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.20<\/b> The system shall be able to link various records together based on a record's metadata, including shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, customer, and more.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"2._Sample_management\">2. Sample management<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th scope=\"col\" style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.1<\/b> The system shall record and maintain the chain of custody for the laboratory's standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.2<\/b> The system shall record the current and historical storage location for the laboratory's standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.3<\/b> The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.4<\/b> The system shall require the recording of a standard and reagent's first opening date.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-5<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.5<\/b> The system shall allow only active standards and reagents to be shown as available for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-6<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.6<\/b> The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.7<\/b> The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, lot or batch ID, field number, test method, assigned user, and status.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-8<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.8<\/b> The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.9<\/b> The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.10<\/b> The system shall be able to link test methods and specifications to standards and reagents.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166\u20137<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.65\" target=\"_blank\">21 CFR Part 606.65 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.151\" target=\"_blank\">21 CFR Part 606.151<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical \u25aa Genetics Laboratories C6.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 12.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.22\u201325<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.11<\/b> The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q1ar2-stability-testing-new-drug-substances-and-products\" target=\"_blank\">FDA Q1A(R2)<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>2.12<\/b> The system should allow authorized users to create projects and research studies in the system\u2014including, e.g., stability studies\u2014and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"3._Core_laboratory_testing_and_experiments\">3. Core laboratory testing and experiments<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.1<\/b> The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.2<\/b> The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-3<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.3<\/b> The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.4<\/b> The system shall be able to check physical, control, and specification limits for an instrument sample.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-6<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.5<\/b> The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-7<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.6<\/b> The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-8<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.7<\/b> The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-9<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.8<\/b> The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-10<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.9<\/b> The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.8.2<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.10<\/b> The system shall allow users to enter operators such as <, >, +, and - with numeric test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-12<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.11<\/b> The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-13<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.12<\/b> The system should effectively alert users upon entry of out-of-specification test results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (c\u2013f)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.325<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.161<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (g)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.202<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G16.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.10<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-14<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.3\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.1\u20134<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.16<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>3.13<\/b> The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.14<\/b> The system shall allow users to link samples, batches, and tests to a specific accreditation approval status (e.g., ANSI National Accreditation Board accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"4._Results_review_and_verification\">4. Results review and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.1.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.1<\/b> The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 1.2<\/a>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.2<\/b> The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.3<\/b> The system shall accurately maintain a full audit trail for modified results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-28\u201329<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G15.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10(3)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.4<\/b> The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.5<\/b> The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-6<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>4.6<\/b> The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 4.0<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.7<\/b> The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span id=\"rdp-ebb-5._Sample,_experiment,_and_study_approval_and_verification\"><\/span><span class=\"mw-headline\" id=\"5._Sample.2C_experiment.2C_and_study_approval_and_verification\">5. Sample, experiment, and study approval and verification<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.12.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.1<\/b> The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.2<\/b> The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-5-3<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>5.3<\/b> The system should provide appropriate functions for specific sample statuses like \"approved,\" \"rejected,\" and \"cancelled,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"6._Reporting\">6. Reporting<\/span><\/h2>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:250px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-1<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.1<\/b> The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.4<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.2<\/b> The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (g) and (h)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.3<\/b> The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-2<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.4<\/b> The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.25\" target=\"_blank\">7 CFR Part 91.25<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (c\u2013e)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-12 and -32<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.5.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.2.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.43<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.5<\/b> The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.26\" target=\"_blank\">7 CFR Part 91.26\u201327<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-4<\/a>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.6<\/b> The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.7<\/b> The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.5\" target=\"_blank\">7 CFR Part 331.5<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.5\" target=\"_blank\">9 CFR Part 121.5\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58.185<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.64\" target=\"_blank\">21 CFR Part 312.64<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.150\" target=\"_blank\">21 CFR Part 812.150<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.31\" target=\"_blank\">40 CFR Part 141.31<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.721\" target=\"_blank\">40 CFR Part 141.721<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\/subpart-C\" target=\"_blank\">40 CFR Part 370 Subpart C<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\/subpart-B\" target=\"_blank\">40 CFR Part 372 Subpart B<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\/subpart-A\" target=\"_blank\">40 CFR Part 717 Subpart A<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.40\" target=\"_blank\">40 CFR Part 720.40<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.5\" target=\"_blank\">42 CFR Part 73.5\u20136<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (d)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-7<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.3.2<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 4, 2.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 4, 1.x<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-6 and IR-6(1)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.8<\/b> The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\n<p>\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.28\" target=\"_blank\">7 CFR Part 91.28<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58 Sec. 58.185 (c)<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.9<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.4<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.3<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.8<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n\u25aa <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.9<\/b> The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.10<\/b> The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding-left:5px; padding-top:5px; padding-bottom:5px;\">\u25aa Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec\n<\/td>\n<td style=\"background-color:white; vertical-align: text-top;\"><b>6.11<\/b> The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis.<br \/> <br \/><hr style=\"width:95%; margin: auto;\" \/><br \/> <br \/>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20230623184906\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.079 seconds\nReal time usage: 0.089 seconds\nPreprocessor visited node count: 816\/1000000\nPost\u2010expand include size: 90373\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 24.344 1 -total\n 19.01% 4.628 1 Template:LIMSpec_for_Cannabis_Testing\/Sample_and_experiment_registration\n 17.01% 4.141 1 Template:LIMSpec_for_Cannabis_Testing\/Reporting\n 16.00% 3.895 1 Template:LIMSpec_for_Cannabis_Testing\/Sample_management\n 15.75% 3.835 1 Template:LIMSpec_for_Cannabis_Testing\/Results_review_and_verification\n 14.87% 3.621 1 Template:LIMSpec_for_Cannabis_Testing\/Core_laboratory_testing_and_experiments\n 13.86% 3.374 1 Template:LIMSpec_for_Cannabis_Testing\/Sample,_experiment,_and_study_approval_and_verification\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5461-0!canonical and timestamp 20230623184905 and revision id 16306. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#1._Sample_and_experiment_registration\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#1._Sample_and_experiment_registration<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","84a636c15976284c4f167d582de08e80_images":[],"84a636c15976284c4f167d582de08e80_timestamp":1687546819,"2e1c22fdf6eeb913ed7216dd143f9672_type":"article","2e1c22fdf6eeb913ed7216dd143f9672_title":"LIMS functionality requirements specific to cannabis testing","2e1c22fdf6eeb913ed7216dd143f9672_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing","2e1c22fdf6eeb913ed7216dd143f9672_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/LIMS functionality requirements specific to cannabis testingFrom CannaQAWikiJump to navigationJump to searchContents \n\n1 LIMS functionality requirements specific to cannabis testing \n\n1.1 Sample registration \n1.2 Pre-loaded cannabis testing protocols, labels, and analytical reports \n1.3 Creation and management of additional protocols, labels, and analytical reports \n1.4 Flexible specification limit sets for quality control \n1.5 Third-party system integration \n1.6 Instrument integration \n1.7 Granular chain-of-custody at every step \n1.8 Inventory reconciliation \n1.9 Real-time alerts and issue tracking \n1.10 Capacity and performance monitoring \n1.11 Data security and confidentiality \n1.12 Accounting and billing \n1.13 Secure web portal \n1.14 ISO\/IEC 17025 compliance support \n1.15 NELAC, ORELAP, and ELAP compliance support \n1.16 Patient Focused Certification (PFC) compliance support \n\n\n2 References \n\n\n\nLIMS functionality requirements specific to cannabis testing \nThe average general-purpose laboratory information management system (LIMS) will have a wide array of functionality. However, such a LIMS developed with quality in mind will take into account additional factors, such as the requirements that current regulatory schemes, industry standards, and organizational guidelines place on the development of a LIMS. This development can and should be framed with a strong specification based on those regulations, standards, and guidelines, a specification such as LIMSpec. Such a specification ideally addresses system requirements involving aspects including but not limited to sample management, reporting, resource management, quality control, system and instrument integration, data integrity, and cybersecurity.\nBut what about the special requirements of a cannabis testing laboratory? How does a specification document like LIMSpec\u2014and by extension, a LIMS\u2014address those laboratory needs? \nAbout the following content\nThe following examines the special needs of cannabis testing laboratories\u2014from quality assurance labs to R&D labs\u2014and how a LIMS can address them. In particular, those stated special needs are matched to the exact requirements statements found in the subsequent chapters of this guide. Additional background is also provided. In a few rare cases, a LIMSpec requirement may not have a specific regulation, standard, or guidance document matched to it. These represent areas where regulatory bodies and standards agencies may need to address a gap in the future.\n\r\n\n\nSample registration \nCannabis testing LIMS requirement: The system should provide sample registration screens optimized for the cannabis testing industry, including the ability to differentiate among medical marijuana, recreational marijuana, and hemp, as well as derivative products and their various substrates. All necessary aspects of information capture should be in place, including listing the documentation included with the sample or lot.\nRelevant LIMSpec: \n\n1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens\u2014including associated measurement units and any other regulation-mandated attributes\u2014based upon the various cannabis substrates\/matrices and derivative products tested, as well as the sample source location and\/or laboratory location.\n1.12 The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.\nAdditional background: Even though some LIMS already provide the ability for users to define their own sample registration screens and fields, it doesn't necessarily mean the vendor will also include pre-loaded screens and preferences for a specific industry or scientific discipline. Those vendors tailoring sample registration screens and preferences specifically to cannabis testing lab requirements for launch-day deployment have a step up on other LIMS vendors. Also, sample registration should also support both remote sampling and in-lab sampling activities.\n\r\n\n\n Pre-loaded cannabis testing protocols, labels, and analytical reports \nCannabis testing LIMS requirement: The system should offer pre-loaded compliant cannabis testing protocols, labels, and analytical reports that are optimized to and readily adjustable for a rapidly changing industry.\nRelevant LIMSpec: \n\n1.2 The system should allow for the creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n6.5 The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.\n6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\nAdditional background: As with sample registration, end users of a cannabis testing LIMS will appreciate having a wide array of pre-loaded testing protocols, label templates, and report templates that support the testing of acid and neutral forms of cannabinoids, potency, strain, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter. This includes the ability to configure measurement units, as well as customize analytical reports such as certificates of analysis (COAs) for multiple state- and locally regulated testing scenarios like batch testing and batch-by-batch variance analysis.\n\r\n\n\n Creation and management of additional protocols, labels, and analytical reports \nCannabis testing LIMS requirement: The system should provide users the tools for creating new, compliant test protocols, labels, and reports, as well as managing them as the industry changes.\nRelevant LIMSpec: \n\n1.2 The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.\n23.9 The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.\nAdditional background: As with pre-loaded protocols, labels, and analytical reports, providing users the ability to create and manage their own protocols, labels, and reports\u2014including COAs\u2014as the industry changes is vital. Similarly, the same need for a flexible yet robust means of adjusting limit sets\u2014and preserving older ones\u2014is also required.\n\r\n\n\nFlexible specification limit sets for quality control \nCannabis testing LIMS requirement: The system should support the development and maintenance of flexible and robust limit sets for various state and local regulations, as well as specific substrate testing requirements, to facilitate better quality control monitoring and reporting.\nRelevant LIMSpec:\n\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n23.2 The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and\/or state and local regulations, including for specific substrate\/matrix types.\nAdditional background: A vital component of the previously mentioned testing protocols that should not be overlooked is how flexible their test parameter\/specification limit sets are. As regulations and standards concerning cannabis testing\u2014across many different substrates\u2014may change rapidly at the federal, state, and local level, adjustments to the limits declared within testing protocols must be easy to make. Additionally, the system should be capable of retaining older historic limit sets, such that past results can later be accurately linked to their original limit sets.[1] When in place, these limit sets can help improve quality control and the reporting of OOS samples and results.\n\r\n\n\nThird-party system integration \nCannabis testing LIMS requirement: The system should provide a means to manually or automatically connect with and securely transfer information between (integrate with) state-required compliance reporting systems, seed-to-sale systems, and other software systems like enterprise resource management (ERP) solutions. \nRelevant LIMSpec:\n\n18.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems, including point-of-sale systems, cultivation management systems, seed-to-sale systems, and any other state- and locally mandated industry reporting systems.\n18.6 The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.\n18.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\n18.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing among instruments and third-party systems like state- and locally mandated seed-to-sale systems.\nAdditional background: Seed-to-sale systems, like METRC, or other types of government-mandated reporting systems may have a web-based user interface (webUI) for manual entry of results data, or they may even support a .csv upload of data. However, manual entry of results can be time consuming and result in a higher likelihood of errors. As such, the more efficient way to report data to those types of systems is through more automated means, connecting your LIMS with a web-based application programming interface (API), typically provided by the vendor of the seed-to-sale or reporting software. This means the LIMS must either be pre-configured to connect with all the necessary APIs or be equipped to handle connection with any API.\n\r\n\n\nInstrument integration \nCannabis testing LIMS requirement: The system should provide robust support for accurately and securely integrating with and collecting data from numerous types of scientific instruments.\nRelevant LIMSpec:\n\n17.1 The system should be able to use an application programming interface or web services to communicate with the instrument data systems common to cannabis testing, including chromatography, spectroscopy, spectrometry, and polymerase chain reaction systems.\n17.2 The system should be capable of sending samples and test orders to the instrument data systems common to cannabis testing.\n17.3 The system should be capable of receiving test results from the instrument data systems common to cannabis testing and verifying those results for completeness and readability.\n17.4 The system should be capable of generically parsing instrument data from the instrument data systems common to cannabis testing, in order to extract important sample details and results.\nAdditional background: From mass spectrometers and chromatography equipment to quantitative polymerase chain reaction (qPCR) systems and moisture balances, being able to accurately and securely transfer analytical data automatically improves turnaround time and better ensures the accuracy of entered results (versus manual data entry). This is particularly important in the highly regulated industry that is cannabis testing.\n\r\n\n\nGranular chain-of-custody at every step \nCannabis testing LIMS requirement: The system should provide accurate, automatic chain-of-custody (CoC) tracking, down to a granular location level (e.g., \"Storage Room 3, Freezer 1, Shelf 3\"), and at every step (including package receipt and sending).\nRelevant LIMSpec:\n\n1.9 The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n1.12 The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.\n1.14 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.\n1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n1.19 In the case of regulated samples such as cannabis, the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required shipping information.\n15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.\nAdditional background: A nickname for a seed-to-sale system is a \"track-and-trace\" system, highlighting the importance of always knowing the who, what, where, when, and how much of cannabis materials and related products in the industry life cycle. This concept is often referred to as the \"chain-of-custody\" of cannabis related material. This chain-of-custody is not limited to received cannabis samples, either; it also includes any subsamples and aliquots generated in the testing laboratory, as well as any disposed materials. As such, it's vital the LIMS be able to accurately document the chain of steps received cannabis materials go through, from reception and retention to delivery and destruction. Without this careful documentation, a cannabis testing lab is open to costly fines or, worst case, having their license suspended.\n\r\n\n\nInventory reconciliation \nCannabis testing LIMS requirement: The system should support inventory reconciliation, including sample weight reconciliation, while limiting data entry errors.\nRelevant LIMSpec:\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n2.9 The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.\n15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.\nAdditional background: Related to the \"how much\" of chain-of-custody tracking, sample weight reconciliation is an important element of avoiding regulatory violations.[2] The LIMS should be able to either automatically deduct sample and inventory quantities when consumed as part of a test (including subsamples and aliquots), or it should allow manual entry of such changes with background validation checks or warnings. For example, the system would need to clearly warn the user when attempting to pull more weight from a sample than exists, which would create a negative value. Speaking of which...\n\r\n\n\nReal-time alerts and issue tracking \nCannabis testing LIMS requirement: The system should support real-time alerts of out-of-specification (OOS) results, incomplete tasks nearing due date, and other situations, so immediate action can be taken, if required. This shall assist with lab efforts towards actively tracking issues for standard-based and regulatory purposes, as well ensure timely results to stakeholders.\nRelevant LIMSpec:\n\n3.12 The system should effectively alert users upon entry of out-of-specification test results.\n12.6 The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date. (Currently no regulatory- or standard-based requirement for this.)\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, prompting a documented investigation to identify the root cause.\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\nAdditional background: As part of maintaining quality assurance and compliance with regulations and standards, it's important users be warned when something goes awry with data entry and analysis. This is typically controlled through the previously mentioned limit sets associated with pre-loaded and custom test protocols. However, other error checking of automatic and manual calculations, e.g., weight reconciliation, should also be inherently built into the LIMS. However, the checks are not enough; users must clearly and promptly be notified of errors and OOS results (via the limit sets) in order to, for example, identify health risks associated with a tested product and send notification that the product should be pulled from store shelves. Additionally, the requirement for maintaining quality testing outcomes for consumer safety and client satisfaction further drives the need for prompt real-time alerts, as does the need for ensuring scheduled tasks are completed before they are due.\n\r\n\n\nCapacity and performance monitoring \nCannabis testing LIMS requirement: The system should provide mechanisms for creating, configuring, and monitoring workload, instrument allocation, and scheduled tasks, as well as other custom key performance measures (KPMs) designated as important by the lab.\nRelevant LIMSpec:\n\n6.10 The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis. (Currently no regulatory- or standard-based requirement for this.)\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n12.1 The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.\n19.1 The system should be able to accurately gauge and report test-based work capacity or throughput.\n19.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\n19.3 The system should provide a means for tasks to be scheduled and allocated against available resources.\n19.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of mycotoxin analyses or hours worked on them.\n23.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\nAdditional background: Whether an R&D cannabis lab or a quality assurance lab for cannabis, monitoring workloads, instrument allocations, scheduled tasks, OOS results, and any lab-specific performance indicators is vital for ensuring quick turnaround time (TAT), accurate results, productive workflows, and positive regulatory outcomes. Similar to issue tracking, capacity and performance tracking also help maintain quality testing outcomes and client satisfaction. Many LIMS already have basic forms of these monitoring features, but not all do, let alone more advanced monitoring functions like custom KPM creation and management. \n\r\n\n\nData security and confidentiality \nCannabis testing LIMS requirement: The system should ensure data security and confidentiality for at-rest and in-transit data.\nRelevant LIMSpec:\n\n26.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256-bit encryption.\n26.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\nAdditional background: When it comes to cannabis and protected health information (PHI), dispensaries are the most likely to require careful attention to consumer information.[3][4] However, that does not preclude laboratories from making strong efforts to protect sensitive personal data related to clients and their analyses (let alone to protect the lab's own validated methods and documentation). As such, cannabis testing labs should rely on a LIMS that uses industry-standard communication protocols and encryption methods to protect not only the data housed in the LIMS but also data moving in and out of it.\n\r\n\n\nAccounting and billing \nCannabis testing LIMS requirement: The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.\nRelevant LIMSpec:\n\n8.9 The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services. (Currently no regulatory- or standard-based requirement for this.)\nAdditional background: Though not necessarily backed by any regulation or standard, carefully tracking expenditures and payments received related to cannabis activities is vital. This is especially true given that the non-hemp (low-THC) Cannabis plant is still technically illegal to grow and process in the eyes of U.S. federal law. As such, some businesses taking in money from cannabis-related activities have had problems with managing the financial aspects of their operations.[5][6][7][8] Given the remaining uncertainty of cannabis legalization in the U.S., and the natural benefits of managing accounting and billing within the LIMS, it makes sense that a LIMS should be able to accurately track receipts and more, down to the penny.\n\r\n\n\nSecure web portal \nCannabis testing LIMS requirement: The system should provide a secure web portal for client results review and test ordering.\nRelevant LIMSpec:\n\n6.11 The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis. (Currently no regulatory- or standard-based requirement for this.)\nAdditional background: Similar to accounting and billing functionality, this requirement for a portal for customer access isn't necessarily mandated by any regulation or standard. However, it remains a useful time-saving and customer service element. Additionally, the \"secure\" part of this requirement must be emphasized. This ties directly to the prior requirement for data security and confidentiality. Web-based attacks remain some of the most popular cybersecurity attacks, targeting the likes of online customer portals and WordPress sites for credentials and sensitive information.[9][10] A quality LIMS that has already proven strong data security gives confidence in the LIMS vendor's ability to implement a web-based customer portal for order review and test ordering.\n\r\n\n\n ISO\/IEC 17025 compliance support \nCannabis testing LIMS requirement: The system should support a laboratory's ISO\/IEC 17025 compliance efforts.\nRelevant LIMSpec:\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.\n4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n6.5 The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.\n6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n7.2 The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\n7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc. as required by a reference method or regulation.\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n18.3 The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\n18.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\n18.11 The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.\n21.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\n21.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\n22.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n23.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n24.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n24.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n25.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\nAdditional background: In the U.S., many states mandate analytical testing of cannabis and its related products. This testing is prescribed as a public health safety measure, to ensure those consuming cannabis and derived products are not adversely affected by any harmful substances picked up during processing stages. By extension the public must place trust in those labs conducting this testing, requiring a high level of quality within the laboratory and how it operates. This quality is better assured through laboratory accreditation checks to standards like ISO\/IEC 17025, which provides competence requirements for testing and calibration laboratories. ISO\/IEC 17025 requirements are non-trivial, covering many aspects of how the laboratory operates, and chief among those requirements is the need for a quality management system. And maintaining quality requires maintaining traceable documentary evidence of those efforts.[11] This includes certificates of analysis, quality manuals, standard operating procedures, calibration and maintenance logs, and much more. Your LIMS should make strong efforts towards helping you maintain that documentary evidence to not only assist with compliance efforts, but also push your lab to maintain high levels of quality for those depending on accurate analyses.\n\r\n\n\n NELAC, ORELAP, and ELAP compliance support \nCannabis testing LIMS requirement: The system should support a laboratory's NELAC or ORELAP compliance efforts.\nCannabis testing LIMS requirement: The system should support a laboratory's ELAP compliance efforts.\nRelevant LIMSpec:\n\n9.9 The system should support a laboratory's NELAC or ELAP compliance efforts. (NOTE: NELAC's Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (2016) is proprietary and could not be obtained. The following LIMSpec items are based off New York's ELAP requirements.)\n2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n7.2 The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.\n7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc. as required by a reference method or regulation.\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\nAdditional background: Though ISO\/IEC 17025 remains the major standard to be accredited to, other accreditation requirements exist in the world of cannabis testing. These requirements may be state-based, as with the Oregon Environmental Laboratory Accreditation Program (ORELAP)[12] or New York's Environmental Laboratory Approval Program, Certification Manual Item 180.7 for Medical Marijuana.[13] Others like the non-profit NELAC Institute provide national accreditation through its National Environmental Laboratory Accreditation Program (NELAP), which ORELAP is largely guided by.[12] This includes NELAC's[14]:\n\nEL-V1M1-2016-Rev2.1 Module 1, \"Proficiency Testing\"\nEL-V1M2-ISO-2016-Rev2.1 Module 2 \"Quality Systems General Requirements\"\nEL-V1M4-2017-Rev2.2 Module 4, \"Quality Systems for Chemical Testing\"\nEL-V1M5-2016-Rev2.0 Module 5, \"Quality Systems for Microbiological Testing\"\nAs such, this means covering ground similar to ISO\/IEC 17025 regarding quality in the laboratory. To better meet these requirements, a cannabis testing LIMS should assist with the maintenance of documentation such as quality manuals, tracking laboratorians' credentials and experience, documenting corrective and preventative action, and documenting proficiency testing results, among other tasks.[15]\n\r\n\n\n Patient Focused Certification (PFC) compliance support \nCannabis testing LIMS requirement: The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.\nRelevant LIMSpec:\n\n9.10 The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts. (NOTE: ASA's PFC document is proprietary and could not be obtained.)\nAdditional background: The American Association for Laboratory Accreditation (A2LA) incorporates the ASA's PFC Program into its cannabis testing laboratory accreditation, described in its R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program document.[16] However, the A2LA will \"only give that document to prospective accreditation customers,\" according to personal communication. As such, it's not clear what those specific PFC requirements are and how they may relate to a LIMS' ability to maintain A2LA's PFC compliance. Presumably those requirements can be better met with a LIMS, whatever the requirements may be. If a vendor indicates their LIMS helps support PFC requirements, it's best to engage in a conversion with the vendor to determine how.\n\nReferences \n\n\n\u2191 LabLynx, Inc (13 October 2011). \"LabLynx KB:SysAdmin - 5.4 LIMS system setup\". LIMSwiki.org. https:\/\/www.limswiki.org\/index.php\/LabLynx_KB:SysAdmin_-_5.4_LIMS_system_setup . Retrieved 21 June 2023 .   \n \n\n\u2191 Moberly, R. (14 May 2020). \"Avoid Infractions: Top 5 METRC Cultivation Violations\". RMCC Blog. https:\/\/www.rockymountaincannabisconsulting.com\/cannabis-business-blog\/2020\/5\/14\/avoid-infractions-top-5-metrc-cultivation-violations . Retrieved 21 June 2023 .   \n \n\n\u2191 Fawkes, G. (24 January 2020). \"Report: Cannabis Users\u2019 Sensitive Data Exposed in Data Breach\". vpnMentor Blog. https:\/\/www.vpnmentor.com\/blog\/report-thsuite-breach\/ . Retrieved 21 June 2023 .   \n \n\n\u2191 Shaghaghi, S.; Weinstein, I. (18 February 2020). \"Leak of 30,000 cannabis customer records heightens need for effective data security\". Insights. CohnReznick LLP. https:\/\/www.cohnreznick.com\/insights\/leak-of-30000-cannabis-customer-records-heightens-need-for-effective-data-security . Retrieved 21 June 2023 .   \n \n\n\u2191 Kovaleski, S.F. (14 February 2014). \"U.S. Issues Marijuana Guidelines for Banks\". The New York Times. The New York Times Corporation. https:\/\/www.nytimes.com\/2014\/02\/15\/us\/us-issues-marijuana-guidelines-for-banks.html . Retrieved 21 June 2023 .   \n \n\n\u2191 Financial Crimes Enforcement Network (14 February 2014). \"BSA Expectations Regarding Marijuana-Related Businesses\". U.S. Department of the Treasury. https:\/\/www.fincen.gov\/resources\/statutes-regulations\/guidance\/bsa-expectations-regarding-marijuana-related-businesses . Retrieved 21 June 2023 .   \n \n\n\u2191 Angell, T. (14 June 2018). \"More Banks Working With Marijuana Businesses, Despite Federal Moves\". Forbes. Forbes Media, LLC. https:\/\/www.forbes.com\/sites\/tomangell\/2018\/06\/14\/more-banks-working-with-marijuana-businesses-despite-federal-moves\/#4d828ed21b1b . Retrieved 21 June 2023 .   \n \n\n\u2191 Boomstein, A.L.; Miller, C.D.; Owen, J.L. (30 October 2019). \"California DBO Offers Guidance on Cannabis Banking\". Manatt, Phelps & Phillips, LLP. https:\/\/www.manatt.com\/insights\/newsletters\/financial-services-law\/california-dbo-offers-guidance-on-cannabis-banking . Retrieved 21 June 2023 .   \n \n\n\u2191 Talalev, A. (22 February 2021). \"Website Hacking Statistics You Should Know in 2022\". WebARX Blog. https:\/\/patchstack.com\/articles\/website-hacking-statistics\/ . Retrieved 21 June 2023 .   \n \n\n\u2191 Ensighten (11 February 2020). \"Top Five Cyberattacks Targeting Your Website in 2020\". Ensighten Blog. https:\/\/www.ensighten.com\/blog\/top-five-cyberattacks-targeting-your-website-in-2020 . Retrieved 21 June 2023 .   \n \n\n\u2191 JonP (31 July 2020). \"How can a cannabis testing lab pass ISO 17025?\". IMSM News. https:\/\/www.imsm.com\/us\/news\/how-can-a-cannabis-testing-lab-pass-iso-17025\/ . Retrieved 21 June 2023 .   \n \n\n\u2191 12.0 12.1 \"Accreditation for Laboratories Testing Cannabis in Oregon\". Oregon Health Authority. https:\/\/www.oregon.gov\/oha\/ph\/LaboratoryServices\/EnvironmentalLaboratoryAccreditation\/Pages\/Cannabis-accreditation.aspx . Retrieved 21 June 2023 .   \n \n\n\u2191 \"Environmental Laboratory Approval Program\". New York State Department of Health Wadsworth Center. https:\/\/www.wadsworth.org\/regulatory\/elap . Retrieved 21 June 2023 .   \n \n\n\u2191 \"Fla. Admin. Code R. 64E-1.0015\". CaseText. 8 December 2020. https:\/\/casetext.com\/regulation\/florida-administrative-code\/department-64-department-of-health\/division-64e-division-of-environmental-health\/chapter-64e-1-certification-of-environmental-testing-laboratories\/section-64e-10015-laboratory-certification-standards . Retrieved 21 June 2023 .   \n \n\n\u2191 New York State Department of Health \u2013 Wadsworth Center (3 December 2020). \"Environmental Laboratory Approval Program (ELAP) and Laboratory of Environmental Biology (LEB): Procedure on How to Perform an Initial Demonstration of Capability (iDOC) for Medical Marijuana Microbiology\" (PDF). New York Department of Health. https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf . Retrieved 21 June 2023 .   \n \n\n\u2191 A2LA. \"Cannabis Testing Laboratory Accreditation Program\". https:\/\/a2la.org\/accreditation\/cannabis-testing\/ . Retrieved 21 June 2023 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 21 June 2023, at 20:36.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","2e1c22fdf6eeb913ed7216dd143f9672_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_LIMS_functionality_requirements_specific_to_cannabis_testing rootpage-RefWork_LIMSpec_for_Cannabis_Testing_LIMS_functionality_requirements_specific_to_cannabis_testing skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/LIMS functionality requirements specific to cannabis testing<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n\n<h2><span class=\"mw-headline\" id=\"LIMS_functionality_requirements_specific_to_cannabis_testing\">LIMS functionality requirements specific to cannabis testing<\/span><\/h2>\n<p>The average general-purpose <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"300b107ea507dc9077934f573fc2f6d6\">laboratory information management system<\/a> (LIMS) will have a wide array of functionality. However, such a LIMS developed with <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Quality_control\" title=\"Quality control\" class=\"wiki-link\" data-key=\"a50e0afa52af1b1741e5ca1c7d711282\">quality<\/a> in mind will take into account additional factors, such as the requirements that current <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:Known_cannabis_testing_regulations_in_the_United_States\" title=\"RefWork:Known cannabis testing regulations in the United States\" class=\"wiki-link\" data-key=\"ff57dfeb7bb057c6b03df91fe39df3dd\">regulatory schemes<\/a>, industry standards, and organizational guidelines place on the development of a LIMS. This development can and should be framed with a strong <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Specification_(technical_standard)\" title=\"Specification (technical standard)\" class=\"wiki-link\" data-key=\"3ae0492d271391e42a63e5b62d2dc5ac\">specification<\/a> based on those regulations, standards, and guidelines, a specification such as <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMSpec_2022_R2\" class=\"extiw wiki-link\" title=\"limswiki:Book:LIMSpec 2022 R2\" data-key=\"df2e12ebefc2379e95f3f1956aac4400\">LIMSpec<\/a>. Such a specification ideally addresses system requirements involving aspects including but not limited to sample management, reporting, resource management, quality control, system and instrument integration, data integrity, and cybersecurity.\n<\/p><p>But what about the special requirements of a <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Cannabis\" title=\"Cannabis\" class=\"wiki-link\" data-key=\"a70b76268930d795518ff1f98d7e500d\">cannabis<\/a> testing <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"ed14e6a67b4b14ad2c190c28455725f6\">laboratory<\/a>? How does a specification document like LIMSpec\u2014and by extension, a LIMS\u2014address those laboratory needs? \n<\/p><p><b>About the following content<\/b>\n<\/p><p>The following examines the special needs of cannabis testing laboratories\u2014from quality assurance labs to R&D labs\u2014and how a LIMS can address them. In particular, those stated special needs are matched to the exact requirements statements found in the subsequent chapters of this guide. Additional background is also provided. In a few rare cases, a LIMSpec requirement may not have a specific regulation, standard, or guidance document matched to it. These represent areas where regulatory bodies and standards agencies may need to address a gap in the future.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Sample_registration\">Sample registration<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should provide sample registration screens optimized for the cannabis testing industry, including the ability to differentiate among <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Cannabis_(drug)\" title=\"Cannabis (drug)\" class=\"wiki-link\" data-key=\"6500790ffdd84957d4b055c47e48efca\">medical marijuana<\/a>, recreational marijuana, and <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Hemp\" title=\"Hemp\" class=\"wiki-link\" data-key=\"c23e30b6cf1df54f1dc338492c9f9da2\">hemp<\/a>, as well as derivative products and their various substrates. All necessary aspects of information capture should be in place, including listing the documentation included with the sample or lot.\n<\/p><p><b>Relevant LIMSpec<\/b>: \n<\/p>\n<ul><li>1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens\u2014including associated measurement units and any other regulation-mandated attributes\u2014based upon the various cannabis substrates\/matrices and derivative products tested, as well as the sample source location and\/or laboratory location.<\/li>\n<li>1.12 The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.<\/li><\/ul>\n<p><b>Additional background<\/b>: Even though some LIMS already provide the ability for users to define their own sample registration screens and fields, it doesn't necessarily mean the vendor will also include pre-loaded screens and preferences for a specific industry or scientific discipline. Those vendors tailoring sample registration screens and preferences specifically to cannabis testing lab requirements for launch-day deployment have a step up on other LIMS vendors. Also, sample registration should also support both remote sampling and in-lab sampling activities.\n<\/p><p><br \/>\n<\/p>\n<h3><span id=\"rdp-ebb-Pre-loaded_cannabis_testing_protocols,_labels,_and_analytical_reports\"><\/span><span class=\"mw-headline\" id=\"Pre-loaded_cannabis_testing_protocols.2C_labels.2C_and_analytical_reports\">Pre-loaded cannabis testing protocols, labels, and analytical reports<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should offer pre-loaded compliant cannabis testing protocols, labels, and analytical reports that are optimized to and readily adjustable for a rapidly changing industry.\n<\/p><p><b>Relevant LIMSpec<\/b>: \n<\/p>\n<ul><li>1.2 The system should allow for the creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.<\/li>\n<li>1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.<\/li>\n<li>4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.<\/li>\n<li>6.5 The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.<\/li>\n<li>6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.<\/li>\n<li>6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.<\/li>\n<li>6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.<\/li><\/ul>\n<p><b>Additional background<\/b>: As with sample registration, end users of a cannabis testing LIMS will appreciate having a wide array of pre-loaded testing protocols, label templates, and report templates that support the testing of acid and neutral forms of cannabinoids, potency, strain, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter. This includes the ability to configure measurement units, as well as customize analytical reports such as <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Certificate_of_analysis\" title=\"Certificate of analysis\" class=\"wiki-link\" data-key=\"6cc0baae52ec9375d84bd65eb12e723b\">certificates of analysis<\/a> (COAs) for multiple state- and locally regulated testing scenarios like batch testing and batch-by-batch variance analysis.\n<\/p><p><br \/>\n<\/p>\n<h3><span id=\"rdp-ebb-Creation_and_management_of_additional_protocols,_labels,_and_analytical_reports\"><\/span><span class=\"mw-headline\" id=\"Creation_and_management_of_additional_protocols.2C_labels.2C_and_analytical_reports\">Creation and management of additional protocols, labels, and analytical reports<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should provide users the tools for creating new, compliant test protocols, labels, and reports, as well as managing them as the industry changes.\n<\/p><p><b>Relevant LIMSpec<\/b>: \n<\/p>\n<ul><li>1.2 The system should allow for creation and use of pre-configured (e.g., for standard inflorescence) and customizable (e.g., for differing substrate\/matrix) sample labels, with barcode support.<\/li>\n<li>1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom cannabis-related analytical tests and test protocols\u2014with configurable measurement units and substrates\/matrices\u2014while preferably coming pre-loaded with common state- and local-compliant cannabis testing protocols. These protocols should include testing for acid and neutral forms of cannabinoids, potency testing, strain identification, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter.<\/li>\n<li>4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.<\/li>\n<li>6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.<\/li>\n<li>7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc., as required by a reference method or regulation.<\/li>\n<li>23.9 The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.<\/li><\/ul>\n<p><b>Additional background<\/b>: As with pre-loaded protocols, labels, and analytical reports, providing users the ability to create and manage their own protocols, labels, and reports\u2014including COAs\u2014as the industry changes is vital. Similarly, the same need for a flexible yet robust means of adjusting limit sets\u2014and preserving older ones\u2014is also required.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Flexible_specification_limit_sets_for_quality_control\">Flexible specification limit sets for quality control<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should support the development and maintenance of flexible and robust limit sets for various state and local regulations, as well as specific substrate testing requirements, to facilitate better quality control monitoring and reporting.\n<\/p><p><b>Relevant LIMSpec<\/b>:\n<\/p>\n<ul><li>4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.<\/li>\n<li>23.2 The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and\/or state and local regulations, including for specific substrate\/matrix types.<\/li><\/ul>\n<p><b>Additional background<\/b>: A vital component of the previously mentioned testing protocols that should not be overlooked is how flexible their test parameter\/specification limit sets are. As regulations and standards concerning cannabis testing\u2014across many different substrates\u2014may change rapidly at the federal, state, and local level, adjustments to the limits declared within testing protocols must be easy to make. Additionally, the system should be capable of retaining older historic limit sets, such that past results can later be accurately linked to their original limit sets.<sup id=\"rdp-ebb-cite_ref-LabLynx5.4LIMS_1-0\" class=\"reference\"><a href=\"#cite_note-LabLynx5.4LIMS-1\">[1]<\/a><\/sup> When in place, these limit sets can help improve quality control and the reporting of OOS samples and results.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Third-party_system_integration\">Third-party system integration<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should provide a means to manually or automatically connect with and securely transfer information between (integrate with) state-required compliance reporting systems, <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Seed-to-sale\" title=\"Seed-to-sale\" class=\"wiki-link\" data-key=\"bac2ef9dbf9d2112c3116b3a683f77f0\">seed-to-sale<\/a> systems, and other software systems like enterprise resource management (ERP) solutions. \n<\/p><p><b>Relevant LIMSpec<\/b>:\n<\/p>\n<ul><li>18.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems, including point-of-sale systems, cultivation management systems, seed-to-sale systems, and any other state- and locally mandated industry reporting systems.<\/li>\n<li>18.6 The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.<\/li>\n<li>18.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.<\/li>\n<li>18.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing among instruments and third-party systems like state- and locally mandated seed-to-sale systems.<\/li><\/ul>\n<p><b>Additional background<\/b>: Seed-to-sale systems, like METRC, or other types of government-mandated reporting systems may have a web-based user interface (webUI) for manual entry of results data, or they may even support a .csv upload of data. However, manual entry of results can be time consuming and result in a higher likelihood of errors. As such, the more efficient way to report data to those types of systems is through more automated means, connecting your LIMS with a web-based (API), typically provided by the vendor of the seed-to-sale or reporting software. This means the LIMS must either be pre-configured to connect with all the necessary APIs or be equipped to handle connection with any API.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Instrument_integration\">Instrument integration<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should provide robust support for accurately and securely integrating with and collecting data from numerous types of scientific instruments.\n<\/p><p><b>Relevant LIMSpec<\/b>:\n<\/p>\n<ul><li>17.1 The system should be able to use an application programming interface or web services to communicate with the instrument data systems common to cannabis testing, including chromatography, spectroscopy, spectrometry, and polymerase chain reaction systems.<\/li>\n<li>17.2 The system should be capable of sending samples and test orders to the instrument data systems common to cannabis testing.<\/li>\n<li>17.3 The system should be capable of receiving test results from the instrument data systems common to cannabis testing and verifying those results for completeness and readability.<\/li>\n<li>17.4 The system should be capable of generically parsing instrument data from the instrument data systems common to cannabis testing, in order to extract important sample details and results.<\/li><\/ul>\n<p><b>Additional background<\/b>: From <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Mass_spectrometry\" title=\"Mass spectrometry\" class=\"wiki-link\" data-key=\"18314b70982e52d5a81db4a757d6461f\">mass spectrometers<\/a> and <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Chromatography\" title=\"Chromatography\" class=\"wiki-link\" data-key=\"1b40e146652470be00cebaf949c68b24\">chromatography<\/a> equipment to quantitative <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Polymerase_chain_reaction\" title=\"Polymerase chain reaction\" class=\"wiki-link\" data-key=\"30b16abfb2a5310671fe9dd52ecd0ce4\">polymerase chain reaction<\/a> (qPCR) systems and moisture balances, being able to accurately and securely transfer analytical data automatically improves turnaround time and better ensures the accuracy of entered results (versus manual data entry). This is particularly important in the highly regulated industry that is cannabis testing.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Granular_chain-of-custody_at_every_step\">Granular chain-of-custody at every step<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should provide accurate, automatic chain-of-custody (CoC) tracking, down to a granular location level (e.g., \"Storage Room 3, Freezer 1, Shelf 3\"), and at every step (including package receipt and sending).\n<\/p><p><b>Relevant LIMSpec<\/b>:\n<\/p>\n<ul><li>1.9 The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.<\/li>\n<li>1.12 The system should allow for the manual or automated recording of sample shipping details such as deliverer, location, shipper sample\/batch\/lot ID, laboratory sample\/batch\/lot ID, shipper ID, included documentation, and relevant dates and times for both preregistered and post-analysis samples and batches, for chain-of-custody tracking purposes.<\/li>\n<li>1.14 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.<\/li>\n<li>1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.<\/li>\n<li>1.19 In the case of regulated samples such as cannabis, the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required shipping information.<\/li>\n<li>15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<\/li><\/ul>\n<p><b>Additional background<\/b>: A nickname for a seed-to-sale system is a \"track-and-trace\" system, highlighting the importance of always knowing the who, what, where, when, and how much of cannabis materials and related products in the industry life cycle. This concept is often referred to as the \"chain-of-custody\" of cannabis related material. This chain-of-custody is not limited to received cannabis samples, either; it also includes any subsamples and aliquots generated in the testing laboratory, as well as any disposed materials. As such, it's vital the LIMS be able to accurately document the chain of steps received cannabis materials go through, from reception and retention to delivery and destruction. Without this careful documentation, a cannabis testing lab is open to costly fines or, worst case, having their license suspended.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Inventory_reconciliation\">Inventory reconciliation<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should support inventory reconciliation, including sample weight reconciliation, while limiting data entry errors.\n<\/p><p><b>Relevant LIMSpec<\/b>:\n<\/p>\n<ul><li>1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.<\/li>\n<li>1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.<\/li>\n<li>2.9 The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.<\/li>\n<li>4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.<\/li>\n<li>15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.<\/li>\n<li>15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<\/li><\/ul>\n<p><b>Additional background<\/b>: Related to the \"how much\" of chain-of-custody tracking, sample weight reconciliation is an important element of avoiding regulatory violations.<sup id=\"rdp-ebb-cite_ref-MoberlyAvoid20_2-0\" class=\"reference\"><a href=\"#cite_note-MoberlyAvoid20-2\">[2]<\/a><\/sup> The LIMS should be able to either automatically deduct sample and inventory quantities when consumed as part of a test (including subsamples and aliquots), or it should allow manual entry of such changes with background validation checks or warnings. For example, the system would need to clearly warn the user when attempting to pull more weight from a sample than exists, which would create a negative value. Speaking of which...\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Real-time_alerts_and_issue_tracking\">Real-time alerts and issue tracking<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should support real-time alerts of out-of-specification (OOS) results, incomplete tasks nearing due date, and other situations, so immediate action can be taken, if required. This shall assist with lab efforts towards actively tracking issues for standard-based and regulatory purposes, as well ensure timely results to stakeholders.\n<\/p><p><b>Relevant LIMSpec<\/b>:\n<\/p>\n<ul><li>3.12 The system should effectively alert users upon entry of out-of-specification test results.<\/li>\n<li>12.6 The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date. (Currently no regulatory- or standard-based requirement for this.)<\/li>\n<li>16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.<\/li>\n<li>16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.<\/li>\n<li>16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, prompting a documented investigation to identify the root cause.<\/li>\n<li>16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.<\/li>\n<li>16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.<\/li>\n<li>16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.<\/li><\/ul>\n<p><b>Additional background<\/b>: As part of maintaining <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_assurance\" class=\"extiw wiki-link\" title=\"limswiki:Quality assurance\" data-key=\"2ede4490f0ea707b14456f44439c0984\">quality assurance<\/a> and compliance with regulations and standards, it's important users be warned when something goes awry with data entry and analysis. This is typically controlled through the previously mentioned limit sets associated with pre-loaded and custom test protocols. However, other error checking of automatic and manual calculations, e.g., weight reconciliation, should also be inherently built into the LIMS. However, the checks are not enough; users must clearly and promptly be notified of errors and OOS results (via the limit sets) in order to, for example, identify health risks associated with a tested product and send notification that the product should be pulled from store shelves. Additionally, the requirement for maintaining quality testing outcomes for consumer safety and client satisfaction further drives the need for prompt real-time alerts, as does the need for ensuring scheduled tasks are completed before they are due.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Capacity_and_performance_monitoring\">Capacity and performance monitoring<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should provide mechanisms for creating, configuring, and monitoring workload, instrument allocation, and scheduled tasks, as well as other custom key performance measures (KPMs) designated as important by the lab.\n<\/p><p><b>Relevant LIMSpec<\/b>:\n<\/p>\n<ul><li>6.10 The system should provide a means to use data and metadata in the system to create formulas for developing key performance measures (KPMs), which can be monitored, visualized, and reported on by authorized personnel on a periodic basis. (Currently no regulatory- or standard-based requirement for this.)<\/li>\n<li>10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.<\/li>\n<li>12.1 The system shall allow users to create, maintain, and revise schedules\u2014and any associated due dates\u2014for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.<\/li>\n<li>19.1 The system should be able to accurately gauge and report test-based work capacity or throughput.<\/li>\n<li>19.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.<\/li>\n<li>19.3 The system should provide a means for tasks to be scheduled and allocated against available resources.<\/li>\n<li>19.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of mycotoxin analyses or hours worked on them.<\/li>\n<li>23.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.<\/li><\/ul>\n<p><b>Additional background<\/b>: Whether an R&D cannabis lab or a quality assurance lab for cannabis, monitoring workloads, instrument allocations, scheduled tasks, OOS results, and any lab-specific performance indicators is vital for ensuring quick turnaround time (TAT), accurate results, productive workflows, and positive regulatory outcomes. Similar to issue tracking, capacity and performance tracking also help maintain quality testing outcomes and client satisfaction. Many LIMS already have basic forms of these monitoring features, but not all do, let alone more advanced monitoring functions like custom KPM creation and management. \n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Data_security_and_confidentiality\">Data security and confidentiality<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should ensure data security and confidentiality for at-rest and in-transit data.\n<\/p><p><b>Relevant LIMSpec<\/b>:\n<\/p>\n<ul><li>26.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256-bit encryption.<\/li>\n<li>26.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.<\/li><\/ul>\n<p><b>Additional background<\/b>: When it comes to cannabis and <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Protected_health_information\" title=\"Protected health information\" class=\"wiki-link\" data-key=\"ce6ef39caf9e3e430e3c96b69340f30c\">protected health information<\/a> (PHI), dispensaries are the most likely to require careful attention to consumer information.<sup id=\"rdp-ebb-cite_ref-FawkesReportCanna20_3-0\" class=\"reference\"><a href=\"#cite_note-FawkesReportCanna20-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ShaghaghiLeak20_4-0\" class=\"reference\"><a href=\"#cite_note-ShaghaghiLeak20-4\">[4]<\/a><\/sup> However, that does not preclude laboratories from making strong efforts to protect sensitive personal data related to clients and their analyses (let alone to protect the lab's own validated methods and documentation). As such, cannabis testing labs should rely on a LIMS that uses industry-standard communication protocols and encryption methods to protect not only the data housed in the LIMS but also data moving in and out of it.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Accounting_and_billing\">Accounting and billing<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.\n<\/p><p><b>Relevant LIMSpec<\/b>:\n<\/p>\n<ul><li>8.9 The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services. (Currently no regulatory- or standard-based requirement for this.)<\/li><\/ul>\n<p><b>Additional background<\/b>: Though not necessarily backed by any regulation or standard, carefully tracking expenditures and payments received related to cannabis activities is vital. This is especially true given that the non-hemp (low-THC) <i>Cannabis<\/i> plant is still technically illegal to grow and process in the eyes of U.S. federal law. As such, some businesses taking in money from cannabis-related activities have had problems with managing the financial aspects of their operations.<sup id=\"rdp-ebb-cite_ref-KovaleskiUS14_5-0\" class=\"reference\"><a href=\"#cite_note-KovaleskiUS14-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FinCEN_BSA14_6-0\" class=\"reference\"><a href=\"#cite_note-FinCEN_BSA14-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AngellMoreBanks18_7-0\" class=\"reference\"><a href=\"#cite_note-AngellMoreBanks18-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BoomsteinCali19_8-0\" class=\"reference\"><a href=\"#cite_note-BoomsteinCali19-8\">[8]<\/a><\/sup> Given the remaining uncertainty of cannabis legalization in the U.S., and the natural benefits of managing accounting and billing within the LIMS, it makes sense that a LIMS should be able to accurately track receipts and more, down to the penny.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Secure_web_portal\">Secure web portal<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should provide a secure web portal for client results review and test ordering.\n<\/p><p><b>Relevant LIMSpec<\/b>:\n<\/p>\n<ul><li>6.11 The system should provide a secure web portal for clients to not only order tests but also review the results of their ordered tests, including full access to the associated certificates of analysis. (Currently no regulatory- or standard-based requirement for this.)<\/li><\/ul>\n<p><b>Additional background<\/b>: Similar to accounting and billing functionality, this requirement for a portal for customer access isn't necessarily mandated by any regulation or standard. However, it remains a useful time-saving and customer service element. Additionally, the \"secure\" part of this requirement must be emphasized. This ties directly to the prior requirement for data security and confidentiality. Web-based attacks remain some of the most popular cybersecurity attacks, targeting the likes of online customer portals and WordPress sites for credentials and sensitive information.<sup id=\"rdp-ebb-cite_ref-TalalevWebsite20_9-0\" class=\"reference\"><a href=\"#cite_note-TalalevWebsite20-9\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EnsightenTop20_10-0\" class=\"reference\"><a href=\"#cite_note-EnsightenTop20-10\">[10]<\/a><\/sup> A quality LIMS that has already proven strong data security gives confidence in the LIMS vendor's ability to implement a web-based customer portal for order review and test ordering.\n<\/p><p><br \/>\n<\/p>\n<h3><span id=\"rdp-ebb-ISO\/IEC_17025_compliance_support\"><\/span><span class=\"mw-headline\" id=\"ISO.2FIEC_17025_compliance_support\">ISO\/IEC 17025 compliance support<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should support a laboratory's <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=ISO\/IEC_17025\" title=\"ISO\/IEC 17025\" class=\"wiki-link\" data-key=\"fb6aed7114b8c5fdf16c569526d6ce48\">ISO\/IEC 17025<\/a> compliance efforts.\n<\/p><p><b>Relevant LIMSpec<\/b>:\n<\/p>\n<ul><li>1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.<\/li>\n<li>2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.<\/li>\n<li>4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.<\/li>\n<li>6.5 The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass\/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.<\/li>\n<li>6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.<\/li>\n<li>7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.<\/li>\n<li>7.2 The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.<\/li>\n<li>7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.<\/li>\n<li>7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc. as required by a reference method or regulation.<\/li>\n<li>7.6 The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.<\/li>\n<li>7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.<\/li>\n<li>8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates\/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.<\/li>\n<li>10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.<\/li>\n<li>10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation, while preventing it from being selected for use.<\/li>\n<li>10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.<\/li>\n<li>10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.<\/li>\n<li>10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.<\/li>\n<li>10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.<\/li>\n<li>16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.<\/li>\n<li>18.3 The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.<\/li>\n<li>18.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.<\/li>\n<li>18.11 The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.<\/li>\n<li>21.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.<\/li>\n<li>21.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.<\/li>\n<li>22.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.<\/li>\n<li>23.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.<\/li>\n<li>24.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.<\/li>\n<li>24.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.<\/li>\n<li>25.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)<\/li><\/ul>\n<p><b>Additional background<\/b>: In the U.S., many states mandate analytical testing of cannabis and its related products. This testing is prescribed as a public health safety measure, to ensure those consuming cannabis and derived products are not adversely affected by any harmful substances picked up during processing stages. By extension the public must place trust in those labs conducting this testing, requiring a high level of quality within the laboratory and how it operates. This quality is better assured through laboratory accreditation checks to standards like ISO\/IEC 17025, which provides competence requirements for testing and calibration laboratories. ISO\/IEC 17025 requirements are non-trivial, covering many aspects of how the laboratory operates, and chief among those requirements is the need for a quality management system. And maintaining quality requires maintaining traceable documentary evidence of those efforts.<sup id=\"rdp-ebb-cite_ref-JonPHowCan20_11-0\" class=\"reference\"><a href=\"#cite_note-JonPHowCan20-11\">[11]<\/a><\/sup> This includes certificates of analysis, quality manuals, standard operating procedures, calibration and maintenance logs, and much more. Your LIMS should make strong efforts towards helping you maintain that documentary evidence to not only assist with compliance efforts, but also push your lab to maintain high levels of quality for those depending on accurate analyses.\n<\/p><p><br \/>\n<\/p>\n<h3><span id=\"rdp-ebb-NELAC,_ORELAP,_and_ELAP_compliance_support\"><\/span><span class=\"mw-headline\" id=\"NELAC.2C_ORELAP.2C_and_ELAP_compliance_support\">NELAC, ORELAP, and ELAP compliance support<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should support a laboratory's NELAC or ORELAP compliance efforts.\n<\/p><p><b>Cannabis testing LIMS requirement<\/b>: The system should support a laboratory's ELAP compliance efforts.\n<\/p><p><b>Relevant LIMSpec<\/b>:\n<\/p>\n<ul><li>9.9 The system should support a laboratory's NELAC or ELAP compliance efforts. (<b>NOTE<\/b>: NELAC's <i>Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis<\/i> (2016) is proprietary and could not be obtained. The following LIMSpec items are based off New York's ELAP requirements.)<\/li>\n<li>2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.<\/li>\n<li>7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.<\/li>\n<li>7.2 The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.<\/li>\n<li>7.5 The system shall allow the creation, approval, rejection, and management of the various cannabis sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned specification limits, holding times, etc. as required by a reference method or regulation.<\/li>\n<li>7.6 The system shall provide a means for recording validation information for modified existing or new in-house cannabis test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.<\/li>\n<li>7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel\u2014per state and local regulations\u2014are able to perform assigned tasks.<\/li>\n<li>16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.<\/li>\n<li>16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.<\/li><\/ul>\n<p><b>Additional background<\/b>: Though ISO\/IEC 17025 remains the major standard to be accredited to, other accreditation requirements exist in the world of cannabis testing. These requirements may be state-based, as with the Oregon Environmental Laboratory Accreditation Program (ORELAP)<sup id=\"rdp-ebb-cite_ref-ORELAP_12-0\" class=\"reference\"><a href=\"#cite_note-ORELAP-12\">[12]<\/a><\/sup> or New York's Environmental Laboratory Approval Program, Certification Manual Item 180.7 for Medical Marijuana.<sup id=\"rdp-ebb-cite_ref-ELAP_13-0\" class=\"reference\"><a href=\"#cite_note-ELAP-13\">[13]<\/a><\/sup> Others like the non-profit NELAC Institute provide national accreditation through its National Environmental Laboratory Accreditation Program (NELAP), which ORELAP is largely guided by.<sup id=\"rdp-ebb-cite_ref-ORELAP_12-1\" class=\"reference\"><a href=\"#cite_note-ORELAP-12\">[12]<\/a><\/sup> This includes NELAC's<sup id=\"rdp-ebb-cite_ref-FLAdmin64E-1.0015_14-0\" class=\"reference\"><a href=\"#cite_note-FLAdmin64E-1.0015-14\">[14]<\/a><\/sup>:\n<\/p>\n<ul><li>EL-V1M1-2016-Rev2.1 Module 1, \"Proficiency Testing\"<\/li>\n<li>EL-V1M2-ISO-2016-Rev2.1 Module 2 \"Quality Systems General Requirements\"<\/li>\n<li>EL-V1M4-2017-Rev2.2 Module 4, \"Quality Systems for Chemical Testing\"<\/li>\n<li>EL-V1M5-2016-Rev2.0 Module 5, \"Quality Systems for Microbiological Testing\"<\/li><\/ul>\n<p>As such, this means covering ground similar to ISO\/IEC 17025 regarding quality in the laboratory. To better meet these requirements, a cannabis testing LIMS should assist with the maintenance of documentation such as quality manuals, tracking laboratorians' credentials and experience, documenting corrective and preventative action, and documenting proficiency testing results, among other tasks.<sup id=\"rdp-ebb-cite_ref-WadsworthEnviron20_15-0\" class=\"reference\"><a href=\"#cite_note-WadsworthEnviron20-15\">[15]<\/a><\/sup>\n<\/p><p><br \/>\n<\/p>\n<h3><span id=\"rdp-ebb-Patient_Focused_Certification_(PFC)_compliance_support\"><\/span><span class=\"mw-headline\" id=\"Patient_Focused_Certification_.28PFC.29_compliance_support\">Patient Focused Certification (PFC) compliance support<\/span><\/h3>\n<p><b>Cannabis testing LIMS requirement<\/b>: The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.\n<\/p><p><b>Relevant LIMSpec<\/b>:\n<\/p>\n<ul><li>9.10 The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts. (<b>NOTE<\/b>: ASA's PFC document is proprietary and could not be obtained.)<\/li><\/ul>\n<p><b>Additional background<\/b>: The American Association for Laboratory Accreditation (A2LA) incorporates the ASA's PFC Program into its cannabis testing laboratory accreditation, described in its <i>R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program<\/i> document.<sup id=\"rdp-ebb-cite_ref-A2LACanna20_16-0\" class=\"reference\"><a href=\"#cite_note-A2LACanna20-16\">[16]<\/a><\/sup> However, the A2LA will \"only give that document to prospective accreditation customers,\" according to personal communication. As such, it's not clear what those specific PFC requirements are and how they may relate to a LIMS' ability to maintain A2LA's PFC compliance. Presumably those requirements can be better met with a LIMS, whatever the requirements may be. If a vendor indicates their LIMS helps support PFC requirements, it's best to engage in a conversion with the vendor to determine how.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-LabLynx5.4LIMS-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LabLynx5.4LIMS_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">LabLynx, Inc (13 October 2011). <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"https:\/\/www.limswiki.org\/index.php\/LabLynx_KB:SysAdmin_-_5.4_LIMS_system_setup\" data-key=\"b91f9a25b56f756b11b671f1109c0dd5\">\"LabLynx KB:SysAdmin - 5.4 LIMS system setup\"<\/a>. <i>LIMSwiki.org<\/i><span class=\"printonly\">. <a rel=\"nofollow\" class=\"external free wiki-link\" href=\"https:\/\/www.limswiki.org\/index.php\/LabLynx_KB:SysAdmin_-_5.4_LIMS_system_setup\" data-key=\"b91f9a25b56f756b11b671f1109c0dd5\">https:\/\/www.limswiki.org\/index.php\/LabLynx_KB:SysAdmin_-_5.4_LIMS_system_setup<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=LabLynx+KB%3ASysAdmin+-+5.4+LIMS+system+setup&rft.atitle=LIMSwiki.org&rft.aulast=LabLynx%2C+Inc&rft.au=LabLynx%2C+Inc&rft.date=13+October+2011&rft_id=https%3A%2F%2Fwww.limswiki.org%2Findex.php%2FLabLynx_KB%3ASysAdmin_-_5.4_LIMS_system_setup&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MoberlyAvoid20-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MoberlyAvoid20_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Moberly, R. (14 May 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.rockymountaincannabisconsulting.com\/cannabis-business-blog\/2020\/5\/14\/avoid-infractions-top-5-metrc-cultivation-violations\" target=\"_blank\">\"Avoid Infractions: Top 5 METRC Cultivation Violations\"<\/a>. <i>RMCC Blog<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.rockymountaincannabisconsulting.com\/cannabis-business-blog\/2020\/5\/14\/avoid-infractions-top-5-metrc-cultivation-violations\" target=\"_blank\">https:\/\/www.rockymountaincannabisconsulting.com\/cannabis-business-blog\/2020\/5\/14\/avoid-infractions-top-5-metrc-cultivation-violations<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Avoid+Infractions%3A+Top+5+METRC+Cultivation+Violations&rft.atitle=RMCC+Blog&rft.aulast=Moberly%2C+R.&rft.au=Moberly%2C+R.&rft.date=14+May+2020&rft_id=https%3A%2F%2Fwww.rockymountaincannabisconsulting.com%2Fcannabis-business-blog%2F2020%2F5%2F14%2Favoid-infractions-top-5-metrc-cultivation-violations&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FawkesReportCanna20-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FawkesReportCanna20_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Fawkes, G. (24 January 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.vpnmentor.com\/blog\/report-thsuite-breach\/\" target=\"_blank\">\"Report: Cannabis Users\u2019 Sensitive Data Exposed in Data Breach\"<\/a>. <i>vpnMentor Blog<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.vpnmentor.com\/blog\/report-thsuite-breach\/\" target=\"_blank\">https:\/\/www.vpnmentor.com\/blog\/report-thsuite-breach\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Report%3A+Cannabis+Users%E2%80%99+Sensitive+Data+Exposed+in+Data+Breach&rft.atitle=vpnMentor+Blog&rft.aulast=Fawkes%2C+G.&rft.au=Fawkes%2C+G.&rft.date=24+January+2020&rft_id=https%3A%2F%2Fwww.vpnmentor.com%2Fblog%2Freport-thsuite-breach%2F&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ShaghaghiLeak20-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ShaghaghiLeak20_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Shaghaghi, S.; Weinstein, I. (18 February 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cohnreznick.com\/insights\/leak-of-30000-cannabis-customer-records-heightens-need-for-effective-data-security\" target=\"_blank\">\"Leak of 30,000 cannabis customer records heightens need for effective data security\"<\/a>. <i>Insights<\/i>. CohnReznick LLP<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cohnreznick.com\/insights\/leak-of-30000-cannabis-customer-records-heightens-need-for-effective-data-security\" target=\"_blank\">https:\/\/www.cohnreznick.com\/insights\/leak-of-30000-cannabis-customer-records-heightens-need-for-effective-data-security<\/a><\/span><span class=\"reference-accessdate\">. 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(14 February 2014). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nytimes.com\/2014\/02\/15\/us\/us-issues-marijuana-guidelines-for-banks.html\" target=\"_blank\">\"U.S. Issues Marijuana Guidelines for Banks\"<\/a>. <i>The New York Times<\/i>. The New York Times Corporation<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.nytimes.com\/2014\/02\/15\/us\/us-issues-marijuana-guidelines-for-banks.html\" target=\"_blank\">https:\/\/www.nytimes.com\/2014\/02\/15\/us\/us-issues-marijuana-guidelines-for-banks.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=U.S.+Issues+Marijuana+Guidelines+for+Banks&rft.atitle=The+New+York+Times&rft.aulast=Kovaleski%2C+S.F.&rft.au=Kovaleski%2C+S.F.&rft.date=14+February+2014&rft.pub=The+New+York+Times+Corporation&rft_id=https%3A%2F%2Fwww.nytimes.com%2F2014%2F02%2F15%2Fus%2Fus-issues-marijuana-guidelines-for-banks.html&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FinCEN_BSA14-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FinCEN_BSA14_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Financial Crimes Enforcement Network (14 February 2014). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fincen.gov\/resources\/statutes-regulations\/guidance\/bsa-expectations-regarding-marijuana-related-businesses\" target=\"_blank\">\"BSA Expectations Regarding Marijuana-Related Businesses\"<\/a>. 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(14 June 2018). <a rel=\"nofollow\" class=\"external text\" href=\"#4d828ed21b1b\">\"More Banks Working With Marijuana Businesses, Despite Federal Moves\"<\/a>. <i>Forbes<\/i>. Forbes Media, LLC<span class=\"printonly\">. <a rel=\"nofollow\" class=\"external free\" href=\"#4d828ed21b1b\">https:\/\/www.forbes.com\/sites\/tomangell\/2018\/06\/14\/more-banks-working-with-marijuana-businesses-despite-federal-moves\/#4d828ed21b1b<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=More+Banks+Working+With+Marijuana+Businesses%2C+Despite+Federal+Moves&rft.atitle=Forbes&rft.aulast=Angell%2C+T.&rft.au=Angell%2C+T.&rft.date=14+June+2018&rft.pub=Forbes+Media%2C+LLC&rft_id=https%3A%2F%2Fwww.forbes.com%2Fsites%2Ftomangell%2F2018%2F06%2F14%2Fmore-banks-working-with-marijuana-businesses-despite-federal-moves%2F%234d828ed21b1b&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BoomsteinCali19-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BoomsteinCali19_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Boomstein, A.L.; Miller, C.D.; Owen, J.L. (30 October 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.manatt.com\/insights\/newsletters\/financial-services-law\/california-dbo-offers-guidance-on-cannabis-banking\" target=\"_blank\">\"California DBO Offers Guidance on Cannabis Banking\"<\/a>. Manatt, Phelps & Phillips, LLP<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.manatt.com\/insights\/newsletters\/financial-services-law\/california-dbo-offers-guidance-on-cannabis-banking\" target=\"_blank\">https:\/\/www.manatt.com\/insights\/newsletters\/financial-services-law\/california-dbo-offers-guidance-on-cannabis-banking<\/a><\/span><span class=\"reference-accessdate\">. 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Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Accreditation+for+Laboratories+Testing+Cannabis+in+Oregon&rft.atitle=&rft.pub=Oregon+Health+Authority&rft_id=https%3A%2F%2Fwww.oregon.gov%2Foha%2Fph%2FLaboratoryServices%2FEnvironmentalLaboratoryAccreditation%2FPages%2FCannabis-accreditation.aspx&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ELAP-13\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ELAP_13-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/elap\" target=\"_blank\">\"Environmental Laboratory Approval Program\"<\/a>. New York State Department of Health Wadsworth Center<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.wadsworth.org\/regulatory\/elap\" target=\"_blank\">https:\/\/www.wadsworth.org\/regulatory\/elap<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Environmental+Laboratory+Approval+Program&rft.atitle=&rft.pub=New+York+State+Department+of+Health+Wadsworth+Center&rft_id=https%3A%2F%2Fwww.wadsworth.org%2Fregulatory%2Felap&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FLAdmin64E-1.0015-14\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FLAdmin64E-1.0015_14-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/casetext.com\/regulation\/florida-administrative-code\/department-64-department-of-health\/division-64e-division-of-environmental-health\/chapter-64e-1-certification-of-environmental-testing-laboratories\/section-64e-10015-laboratory-certification-standards\" target=\"_blank\">\"Fla. Admin. Code R. 64E-1.0015\"<\/a>. <i>CaseText<\/i>. 8 December 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/casetext.com\/regulation\/florida-administrative-code\/department-64-department-of-health\/division-64e-division-of-environmental-health\/chapter-64e-1-certification-of-environmental-testing-laboratories\/section-64e-10015-laboratory-certification-standards\" target=\"_blank\">https:\/\/casetext.com\/regulation\/florida-administrative-code\/department-64-department-of-health\/division-64e-division-of-environmental-health\/chapter-64e-1-certification-of-environmental-testing-laboratories\/section-64e-10015-laboratory-certification-standards<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Fla.+Admin.+Code+R.+64E-1.0015&rft.atitle=CaseText&rft.date=8+December+2020&rft_id=https%3A%2F%2Fcasetext.com%2Fregulation%2Fflorida-administrative-code%2Fdepartment-64-department-of-health%2Fdivision-64e-division-of-environmental-health%2Fchapter-64e-1-certification-of-environmental-testing-laboratories%2Fsection-64e-10015-laboratory-certification-standards&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WadsworthEnviron20-15\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WadsworthEnviron20_15-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">New York State Department of Health \u2013 Wadsworth Center (3 December 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">\"Environmental Laboratory Approval Program (ELAP) and Laboratory of Environmental Biology (LEB): Procedure on How to Perform an Initial Demonstration of Capability (iDOC) for Medical Marijuana Microbiology\"<\/a> (PDF). New York Department of Health<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Environmental+Laboratory+Approval+Program+%28ELAP%29+and+Laboratory+of+Environmental+Biology+%28LEB%29%3A+Procedure+on+How+to+Perform+an+Initial+Demonstration+of+Capability+%28iDOC%29+for+Medical+Marijuana+Microbiology&rft.atitle=&rft.aulast=New+York+State+Department+of+Health+%E2%80%93+Wadsworth+Center&rft.au=New+York+State+Department+of+Health+%E2%80%93+Wadsworth+Center&rft.date=3+December+2020&rft.pub=New+York+Department+of+Health&rft_id=https%3A%2F%2Fwww.wadsworth.org%2Fsites%2Fdefault%2Ffiles%2FWebDoc%2FMM%2520guidance%2520procedure%2520for%2520Micro%2520iDOC-120320.pdf&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-A2LACanna20-16\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-A2LACanna20_16-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">A2LA. <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/a2la.org\/accreditation\/cannabis-testing\/\" target=\"_blank\">\"Cannabis Testing Laboratory Accreditation Program\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/a2la.org\/accreditation\/cannabis-testing\/\" target=\"_blank\">https:\/\/a2la.org\/accreditation\/cannabis-testing\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Cannabis+Testing+Laboratory+Accreditation+Program&rft.atitle=&rft.aulast=A2LA&rft.au=A2LA&rft_id=https%3A%2F%2Fa2la.org%2Faccreditation%2Fcannabis-testing%2F&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230623184131\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.253 seconds\nReal time usage: 0.267 seconds\nPreprocessor visited node count: 11225\/1000000\nPost\u2010expand include size: 82853\/2097152 bytes\nTemplate argument size: 34935\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 26623\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 214.286 1 -total\n100.00% 214.286 1 Template:Reflist\n 88.44% 189.504 16 Template:Cite_web\n 81.21% 174.029 16 Template:Citation\/core\n 18.58% 39.817 13 Template:Date\n 6.07% 13.009 26 Template:Citation\/make_link\n 1.89% 4.060 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5459-0!canonical and timestamp 20230623184131 and revision id 18316. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","2e1c22fdf6eeb913ed7216dd143f9672_images":[],"2e1c22fdf6eeb913ed7216dd143f9672_timestamp":1687546819,"ebb7368a68b355f031cd0c0d5ed5e26a_type":"article","ebb7368a68b355f031cd0c0d5ed5e26a_title":"Introduction and methodology","ebb7368a68b355f031cd0c0d5ed5e26a_url":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology","ebb7368a68b355f031cd0c0d5ed5e26a_plaintext":"\n\nRefWork:LIMSpec for Cannabis Testing\/Introduction and methodologyFrom CannaQAWikiJump to navigationJump to searchIntroduction to specifications \nMerriam-Webster defines a \"specification\" as \"a detailed precise presentation of something or of a plan or proposal for something.\"[1] In other words, an existing or theoretical product, concept, or idea is presented in detail for a particular audience. In a broad sense, detailing the specifics about a project, concept, or idea to others is just common sense. This applies just as well to the world of software development, where a software requirements specification is essential for preventing the second most commonly cited reason for project failure: poor requirements management.[2] \nIn fact, the ISO\/IEC\/IEEE 29148:2018 standard (a conglomeration of what was formerly IEEE 830 and other standards) is in place to help specify \"the required processes implemented in the engineering activities that result in requirements for systems and software products\" and provide guidelines for how to apply those requirements.[3] The standard describes the characteristics that make up quality software requirement development, including aspects such as[4]:\n\ncorrectly describing system behavior;\neffectively removing ambiguity from the language used;\ncompletely covering the system behavior and features;\naccurately prioritizing and ranking the requirements; and\nunequivocally ensuring the requirements are testable, modifiable, and traceable.\nA requirement typically comes in the form of a statement that begins with \"the system\/user\/vendor shall\/should ...\" and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level) or specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered. An example of a functional software requirement could be \"the user shall be able to query either all of the initial set of databases or select a subset from it.\" This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state \"the system's query tool shall conform to the ABC 123-2014 standard.\" The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.[5]\nOver the years, a wide variety of companies, consultants, and researchers have compiled public and private software requirements specifications for laboratory informatics systems. These compiled lists of requirements for how a given laboratory informatics solution should be developed, delivered, and maintained have changed as technology and user demand evolved. Often times, these requirements documents turn into a mix of \"wishlist\" requirements from potential and active clients, as well as regulation-mandated requirements. The wishlist items aren't necessarily ignored by developers, but they do in fact have to be prioritized as \"nice to have\" or \"essential to system operation,\" or something in between.[6][7][8] While this reasonable mix of requirements has served informatics software developers well[9], sometimes a fresh approach is required.\n\nA LIMS specification for cannabis analyses \nMany years ago, a list of software specifications for the development of a laboratory information management system (LIMS), referred to as LIMSpec, was developed. It has seen many iterations over the years, including a complete overhaul in 2019. That overhaul was an attempt to look less at the wishlists of laboratories and more directly at what requirements current regulatory schemes, industry standards, and organizational guidelines place on the ever-evolving array of laboratory informatics systems being developed today. At its core is the ASTM E1578-18 Standard Guide for Laboratory Informatics, along with numerous other relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained.\nThis LIMSpec for cannabis testing takes the base LIMSpec 2022 R2 document and tweaks it to address the informatics needs of a cannabis testing laboratory. This includes laboratories testing not only leaf and flower material but also their constituents, and the products made from them, regardless of whether derived from low-THC hemp, medical cannabinoids or a more psychoactive recreational cannabis plant. To be fair, this LIMSpec for cannabis testing doesn't differ much from the base LIMSpec 2022 document; there's a surprising amount of feature crossover. How those features are implemented to address the needs of a cannabis testing laboratory, however, can truly separate a generic all-purpose LIMS from one that is developed to fully address those needs. (In the next section you'll see what LIMS requirements best support a cannabis testing lab and how LIMSpec addresses those requirements.) \nWhen reviewing LIMSpec, you'll notice that in almost every case a requirement statement has at least one linked regulation, standard, or guidance item. A rare few requirements (e.g., a secure portal for third-party access) will not have such an item, meaning no regulatory- or standards-based mandate could be found to support the system requirement. In a few cases, the standard backing a requirement is a proprietary standard. In those cases, the standard was either purchased for review or heavily researched using supporting documentation, and the link goes to the acquisition page for the standard. In other cases, some standards-based sources have been intentionally omitted from the LIMSpec. For example, the AOAC International Official Methods of Analysis are both proprietary and more or less prohibitively expensive. In other cases such as the U.S. Food Emergency Response Network, the Laboratory Response Network, and the American Association for Laboratory Accreditation (A2LA), they unfortunately don't make their standardized procedures open to the public.\nFinally, note that a Microsoft Word version of this specification is available to you, the reader. For more about this downloadable version, see the final chapter of this guide.\n\nReferences \n\n\n\u2191 \"specification\". Merriam-Webster. Merriam-Webster, Inc. https:\/\/www.merriam-webster.com\/dictionary\/specification . Retrieved 21 June 2023 .   \n \n\n\u2191 Bieg, D.P. (August 2014). \"Introduction\" (PDF). Requirements Management: A Core Competency for Project and Program Success. Project Management Institute. p. 3. https:\/\/www.pmi.org\/-\/media\/pmi\/documents\/public\/pdf\/learning\/thought-leadership\/pulse\/requirements-management.pdf . Retrieved 21 June 2023 .   \n \n\n\u2191 \"ISO\/IEC\/IEEE 29148:2018\". International Organization for Standardization. November 2018. https:\/\/www.iso.org\/standard\/72089.html . Retrieved 21 June 2023 .   \n \n\n\u2191 Seibert, P. (28 July 2011). \"How do you write software requirements? What are software requirements? What is a software requirement?\". HubTechInsider. https:\/\/hubtechinsider.wordpress.com\/2011\/07\/28\/how-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement\/ . Retrieved 21 June 2023 .   \n \n\n\u2191 Memon, A. (Spring 2010). \"Software Requirements: Descriptions and specifications of a system\" (PDF). University of Maryland. https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf . Retrieved 21 June 2023 .   \n \n\n\u2191 Aasem, M.; Ramzan, M.; Jaffar, A. (2010). \"Analysis and optimization of software requirements prioritization techniques\". Proceedings from the 2010 International Conference on Information and Emerging Technologies: 1\u20136. doi:10.1109\/ICIET.2010.5625687.   \n \n\n\u2191 Hirsch, J. (22 November 2013). \"10 Steps To Successful Requirements Gathering\". Phase2 Technology, LLC. https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering . Retrieved 21 June 2023 .   \n \n\n\u2191 Burris, E. (2007). \"Requirements Specification\". CS451R, University of Missouri\u2013Kansas City. University of Missouri\u2013Kansas City. Archived from the original on 24 July 2019. https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/ . Retrieved 21 June 2023 .   \n \n\n\u2191 Hofmann, H.F.; Lehner, F. (2001). \"Requirements engineering as a success factor in software projects\". IEEE Software 18 (4): 58\u201366. doi:10.1109\/MS.2001.936219.   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology<\/a>\nNavigation menuPage actionsRefWorkDiscussionView sourceHistoryPage actionsRefWorkDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageList of articlesRandom pageRecent changesHelpSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPrintable versionPermanent linkPage information This page was last edited on 23 June 2023, at 18:58.Content is available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License unless otherwise noted.Privacy policyAbout CannaQAWikiDisclaimers\n","ebb7368a68b355f031cd0c0d5ed5e26a_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-160 ns-subject page-RefWork_LIMSpec_for_Cannabis_Testing_Introduction_and_methodology rootpage-RefWork_LIMSpec_for_Cannabis_Testing_Introduction_and_methodology skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">RefWork:LIMSpec for Cannabis Testing\/Introduction and methodology<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><h2><span class=\"mw-headline\" id=\"Introduction_to_specifications\">Introduction to specifications<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=File:Systems_Requirement_Analysis.jpg\" class=\"image wiki-link\" data-key=\"eaf11d941b2138459fed09dcec18c4e4\"><img alt=\"Systems Requirement Analysis.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/9\/9b\/Systems_Requirement_Analysis.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>Merriam-Webster defines a \"specification\" as \"a detailed precise presentation of something or of a plan or proposal for something.\"<sup id=\"rdp-ebb-cite_ref-MWSpec_1-0\" class=\"reference\"><a href=\"#cite_note-MWSpec-1\">[1]<\/a><\/sup> In other words, an existing or theoretical product, concept, or idea is presented in detail for a particular audience. In a broad sense, detailing the specifics about a project, concept, or idea to others is just common sense. This applies just as well to the world of software development, where a software requirements specification is essential for preventing the second most commonly cited reason for project failure: poor requirements management.<sup id=\"rdp-ebb-cite_ref-BiegRequire14_2-0\" class=\"reference\"><a href=\"#cite_note-BiegRequire14-2\">[2]<\/a><\/sup> \n<\/p><p>In fact, the ISO\/IEC\/IEEE 29148:2018 standard (a conglomeration of what was formerly IEEE 830 and other standards) is in place to help specify \"the required processes implemented in the engineering activities that result in requirements for systems and software products\" and provide guidelines for how to apply those requirements.<sup id=\"rdp-ebb-cite_ref-ISO29148_3-0\" class=\"reference\"><a href=\"#cite_note-ISO29148-3\">[3]<\/a><\/sup> The standard describes the characteristics that make up quality software requirement development, including aspects such as<sup id=\"rdp-ebb-cite_ref-SeibertHowDoYou11_4-0\" class=\"reference\"><a href=\"#cite_note-SeibertHowDoYou11-4\">[4]<\/a><\/sup>:\n<\/p>\n<ul><li>correctly describing system behavior;<\/li>\n<li>effectively removing ambiguity from the language used;<\/li>\n<li>completely covering the system behavior and features;<\/li>\n<li>accurately prioritizing and ranking the requirements; and<\/li>\n<li>unequivocally ensuring the requirements are testable, modifiable, and traceable.<\/li><\/ul>\n<p>A requirement typically comes in the form of a statement that begins with \"the system\/user\/vendor shall\/should ...\" and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level) or specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered. An example of a functional software requirement could be \"the user shall be able to query either all of the initial set of databases or select a subset from it.\" This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state \"the system's query tool shall conform to the ABC 123-2014 standard.\" The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.<sup id=\"rdp-ebb-cite_ref-MemonSoftware10_5-0\" class=\"reference\"><a href=\"#cite_note-MemonSoftware10-5\">[5]<\/a><\/sup>\n<\/p><p>Over the years, a wide variety of companies, consultants, and researchers have compiled public and private software requirements specifications for <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"ac59b0790517a6fa5b6ba2b5c97cc6ac\">laboratory informatics<\/a> systems. These compiled lists of requirements for how a given laboratory informatics solution should be developed, delivered, and maintained have changed as technology and user demand evolved. Often times, these requirements documents turn into a mix of \"wishlist\" requirements from potential and active clients, as well as regulation-mandated requirements. The wishlist items aren't necessarily ignored by developers, but they do in fact have to be prioritized as \"nice to have\" or \"essential to system operation,\" or something in between.<sup id=\"rdp-ebb-cite_ref-AasemAnalysis10_6-0\" class=\"reference\"><a href=\"#cite_note-AasemAnalysis10-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Hirsch10Steps13_7-0\" class=\"reference\"><a href=\"#cite_note-Hirsch10Steps13-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BurrissSoftware07_8-0\" class=\"reference\"><a href=\"#cite_note-BurrissSoftware07-8\">[8]<\/a><\/sup> While this reasonable mix of requirements has served informatics software developers well<sup id=\"rdp-ebb-cite_ref-HofmannRequire01_9-0\" class=\"reference\"><a href=\"#cite_note-HofmannRequire01-9\">[9]<\/a><\/sup>, sometimes a fresh approach is required.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"A_LIMS_specification_for_cannabis_analyses\">A LIMS specification for cannabis analyses<\/span><\/h2>\n<p>Many years ago, a list of software specifications for the development of a <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"300b107ea507dc9077934f573fc2f6d6\">laboratory information management system<\/a> (LIMS), referred to as LIMSpec, was developed. It has seen many iterations over the years, including a complete overhaul in 2019. That overhaul was an attempt to look less at the wishlists of laboratories and more directly at what requirements current regulatory schemes, industry standards, and organizational guidelines place on the ever-evolving array of laboratory informatics systems being developed today. At its core is the <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" class=\"extiw wiki-link\" title=\"limswiki:ASTM E1578\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> <i>Standard Guide for Laboratory Informatics<\/i>, along with numerous other relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained.\n<\/p><p>This LIMSpec for <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Cannabis\" title=\"Cannabis\" class=\"wiki-link\" data-key=\"a70b76268930d795518ff1f98d7e500d\">cannabis<\/a> testing takes the base <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMSpec_2022_R2\" class=\"extiw wiki-link\" title=\"limswiki:Book:LIMSpec 2022 R2\" data-key=\"df2e12ebefc2379e95f3f1956aac4400\">LIMSpec 2022 R2<\/a> document and tweaks it to address the informatics needs of a cannabis testing laboratory. This includes laboratories testing not only leaf and flower material but also their constituents, and the products made from them, regardless of whether derived from <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=THC\" class=\"mw-redirect wiki-link\" title=\"THC\" data-key=\"49178a9ff17554cbfe6c621d70cd3796\">low-THC<\/a> <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Hemp\" title=\"Hemp\" class=\"wiki-link\" data-key=\"c23e30b6cf1df54f1dc338492c9f9da2\">hemp<\/a>, medical cannabinoids or a more <a href=\"https:\/\/www.cannaqa.wiki\/index.php?title=Psychoactive_drug\" title=\"Psychoactive drug\" class=\"wiki-link\" data-key=\"abba12c7100bf1c8457208da20b4234b\">psychoactive<\/a> recreational cannabis plant. To be fair, this LIMSpec for cannabis testing doesn't differ much from the base LIMSpec 2022 document; there's a surprising amount of feature crossover. How those features are implemented to address the needs of a cannabis testing laboratory, however, can truly separate a generic all-purpose LIMS from one that is developed to fully address those needs. (In the next section you'll see what LIMS requirements best support a cannabis testing lab and how LIMSpec addresses those requirements.) \n<\/p><p>When reviewing LIMSpec, you'll notice that in almost every case a requirement statement has at least one linked regulation, standard, or guidance item. A rare few requirements (e.g., a secure portal for third-party access) will not have such an item, meaning no regulatory- or standards-based mandate could be found to support the system requirement. In a few cases, the standard backing a requirement is a proprietary standard. In those cases, the standard was either purchased for review or heavily researched using supporting documentation, and the link goes to the acquisition page for the standard. In other cases, some standards-based sources have been intentionally omitted from the LIMSpec. For example, the AOAC International Official Methods of Analysis are both proprietary and more or less prohibitively expensive. In other cases such as the U.S. Food Emergency Response Network, the Laboratory Response Network, and the American Association for Laboratory Accreditation (A2LA), they unfortunately don't make their standardized procedures open to the public.\n<\/p><p>Finally, note that a Microsoft Word version of this specification is available to you, the reader. For more about this downloadable version, see the final chapter of this guide.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-MWSpec-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MWSpec_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.merriam-webster.com\/dictionary\/specification\" target=\"_blank\">\"specification\"<\/a>. <i>Merriam-Webster<\/i>. Merriam-Webster, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.merriam-webster.com\/dictionary\/specification\" target=\"_blank\">https:\/\/www.merriam-webster.com\/dictionary\/specification<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=specification&rft.atitle=Merriam-Webster&rft.pub=Merriam-Webster%2C+Inc&rft_id=https%3A%2F%2Fwww.merriam-webster.com%2Fdictionary%2Fspecification&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BiegRequire14-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BiegRequire14_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Bieg, D.P. (August 2014). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pmi.org\/-\/media\/pmi\/documents\/public\/pdf\/learning\/thought-leadership\/pulse\/requirements-management.pdf\" target=\"_blank\">\"Introduction\"<\/a> (PDF). <i>Requirements Management: A Core Competency for Project and Program Success<\/i>. Project Management Institute. p. 3<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.pmi.org\/-\/media\/pmi\/documents\/public\/pdf\/learning\/thought-leadership\/pulse\/requirements-management.pdf\" target=\"_blank\">https:\/\/www.pmi.org\/-\/media\/pmi\/documents\/public\/pdf\/learning\/thought-leadership\/pulse\/requirements-management.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Introduction&rft.atitle=Requirements+Management%3A+A+Core+Competency+for+Project+and+Program+Success&rft.aulast=Bieg%2C+D.P.&rft.au=Bieg%2C+D.P.&rft.date=August+2014&rft.pages=p.+3&rft.pub=Project+Management+Institute&rft_id=https%3A%2F%2Fwww.pmi.org%2F-%2Fmedia%2Fpmi%2Fdocuments%2Fpublic%2Fpdf%2Flearning%2Fthought-leadership%2Fpulse%2Frequirements-management.pdf&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ISO29148-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ISO29148_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/72089.html\" target=\"_blank\">\"ISO\/IEC\/IEEE 29148:2018\"<\/a>. 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Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ISO%2FIEC%2FIEEE+29148%3A2018&rft.atitle=&rft.date=November+2018&rft.pub=International+Organization+for+Standardization&rft_id=https%3A%2F%2Fwww.iso.org%2Fstandard%2F72089.html&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SeibertHowDoYou11-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SeibertHowDoYou11_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Seibert, P. (28 July 2011). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/hubtechinsider.wordpress.com\/2011\/07\/28\/how-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement\/\" target=\"_blank\">\"How do you write software requirements? What are software requirements? What is a software requirement?\"<\/a>. <i>HubTechInsider<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/hubtechinsider.wordpress.com\/2011\/07\/28\/how-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement\/\" target=\"_blank\">https:\/\/hubtechinsider.wordpress.com\/2011\/07\/28\/how-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+do+you+write+software+requirements%3F+What+are+software+requirements%3F+What+is+a+software+requirement%3F&rft.atitle=HubTechInsider&rft.aulast=Seibert%2C+P.&rft.au=Seibert%2C+P.&rft.date=28+July+2011&rft_id=https%3A%2F%2Fhubtechinsider.wordpress.com%2F2011%2F07%2F28%2Fhow-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement%2F&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MemonSoftware10-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MemonSoftware10_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Memon, A. (Spring 2010). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf\" target=\"_blank\">\"Software Requirements: Descriptions and specifications of a system\"<\/a> (PDF). University of Maryland<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf\" target=\"_blank\">https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Requirements%3A+Descriptions+and+specifications+of+a+system&rft.atitle=&rft.aulast=Memon%2C+A.&rft.au=Memon%2C+A.&rft.date=Spring+2010&rft.pub=University+of+Maryland&rft_id=https%3A%2F%2Fwww.cs.umd.edu%2F%7Eatif%2FTeaching%2FSpring2010%2FSlides%2F3.pdf&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AasemAnalysis10-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AasemAnalysis10_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Aasem, M.; Ramzan, M.; Jaffar, A. (2010). \"Analysis and optimization of software requirements prioritization techniques\". <i>Proceedings from the 2010 International Conference on Information and Emerging Technologies<\/i>: 1\u20136. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1109%2FICIET.2010.5625687\" target=\"_blank\">10.1109\/ICIET.2010.5625687<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Analysis+and+optimization+of+software+requirements+prioritization+techniques&rft.jtitle=Proceedings+from+the+2010+International+Conference+on+Information+and+Emerging+Technologies&rft.aulast=Aasem%2C+M.%3B+Ramzan%2C+M.%3B+Jaffar%2C+A.&rft.au=Aasem%2C+M.%3B+Ramzan%2C+M.%3B+Jaffar%2C+A.&rft.date=2010&rft.pages=1%E2%80%936&rft_id=info:doi\/10.1109%2FICIET.2010.5625687&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Hirsch10Steps13-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Hirsch10Steps13_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Hirsch, J. (22 November 2013). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering\" target=\"_blank\">\"10 Steps To Successful Requirements Gathering\"<\/a>. Phase2 Technology, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering\" target=\"_blank\">https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=10+Steps+To+Successful+Requirements+Gathering&rft.atitle=&rft.aulast=Hirsch%2C+J.&rft.au=Hirsch%2C+J.&rft.date=22+November+2013&rft.pub=Phase2+Technology%2C+LLC&rft_id=https%3A%2F%2Fwww.phase2technology.com%2Fblog%2Fsuccessful-requirements-gathering&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BurrissSoftware07-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BurrissSoftware07_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Burris, E. (2007). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">\"Requirements Specification\"<\/a>. <i>CS451R, University of Missouri\u2013Kansas City<\/i>. University of Missouri\u2013Kansas City. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">the original<\/a> on 24 July 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 June 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Requirements+Specification&rft.atitle=CS451R%2C+University+of+Missouri%E2%80%93Kansas+City&rft.aulast=Burris%2C+E.&rft.au=Burris%2C+E.&rft.date=2007&rft.pub=University+of+Missouri%E2%80%93Kansas+City&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20190724173601%2Fhttp%3A%2F%2Fsce2.umkc.edu%2FBIT%2Fburrise%2Fpl%2Frequirements%2F&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HofmannRequire01-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HofmannRequire01_9-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Hofmann, H.F.; Lehner, F. (2001). \"Requirements engineering as a success factor in software projects\". <i>IEEE Software<\/i> <b>18<\/b> (4): 58\u201366. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1109%2FMS.2001.936219\" target=\"_blank\">10.1109\/MS.2001.936219<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Requirements+engineering+as+a+success+factor+in+software+projects&rft.jtitle=IEEE+Software&rft.aulast=Hofmann%2C+H.F.%3B+Lehner%2C+F.&rft.au=Hofmann%2C+H.F.%3B+Lehner%2C+F.&rft.date=2001&rft.volume=18&rft.issue=4&rft.pages=58%E2%80%9366&rft_id=info:doi\/10.1109%2FMS.2001.936219&rfr_id=info:sid\/en.wikipedia.org:RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230623185839\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.438 seconds\nReal time usage: 0.907 seconds\nPreprocessor visited node count: 6315\/1000000\nPost\u2010expand include size: 42434\/2097152 bytes\nTemplate argument size: 16941\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 14063\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 121.117 1 -total\n100.00% 121.117 1 Template:Reflist\n 73.79% 89.376 9 Template:Citation\/core\n 63.20% 76.542 7 Template:Cite_web\n 24.98% 30.256 2 Template:Cite_journal\n 12.10% 14.660 6 Template:Date\n 9.49% 11.492 2 Template:Citation\/identifier\n 4.91% 5.948 14 Template:Citation\/make_link\n 2.79% 3.381 4 Template:Hide_in_print\n 2.48% 3.006 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key cannaqa_wiki:pcache:idhash:5457-0!canonical and timestamp 20230623185838 and revision id 18375. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology\">https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n<\/body>","ebb7368a68b355f031cd0c0d5ed5e26a_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/9\/9b\/Systems_Requirement_Analysis.jpg"],"ebb7368a68b355f031cd0c0d5ed5e26a_timestamp":1687546819,"71418df45ef46a0f40bd390be0bd5434":{"type":"chapter","title":"1. Introduction","key":"71418df45ef46a0f40bd390be0bd5434"}},"link":"https:\/\/www.cannaqa.wiki\/index.php?title=Book:LIMSpec_for_Cannabis_Testing","price_currency":"","price_amount":"","book_size":"","download_url":"https:\/\/www.limsforum.com?ebb_action=book_download&book_id=108204","language":"","cta_button_content":"","toc":[{"type":"chapter","name":"1. Introduction","id":"71418df45ef46a0f40bd390be0bd5434","children":[{"type":"article","name":"Introduction and methodology","id":"ebb7368a68b355f031cd0c0d5ed5e26a","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Introduction_and_methodology"},{"type":"article","name":"LIMS functionality requirements specific to cannabis testing","id":"2e1c22fdf6eeb913ed7216dd143f9672","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/LIMS_functionality_requirements_specific_to_cannabis_testing"}]},{"type":"chapter","name":"2. Primary laboratory workflow","id":"107cc25d8b19baa8a163fd263cd3a551","children":[{"type":"article","name":"1. Sample and experiment registration","id":"84a636c15976284c4f167d582de08e80","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#1._Sample_and_experiment_registration"},{"type":"article","name":"2. Sample management","id":"9e195f180d77773bc2eed3b21453e276","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#2._Sample_management"},{"type":"article","name":"3. Core laboratory testing and experiments","id":"935a30c09d1fa5a3d603971953db22b8","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#3._Core_laboratory_testing_and_experiments"},{"type":"article","name":"4. Results review and verification","id":"e28537905dad573e5a44941545b0d7ad","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#4._Results_review_and_verification"},{"type":"article","name":"5. Sample, experiment, and study approval and verification","id":"3ba7a90aa5cf7c32844e9a2b57c49fb5","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#5._Sample.2C_experiment.2C_and_study_approval_and_verification"},{"type":"article","name":"6. Reporting","id":"60bb82c8eae2932c0b0770c6c668caf1","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Primary_laboratory_workflow#6._Reporting"}]},{"type":"chapter","name":"3. Maintaining laboratory workflow and operations","id":"18c556433b79bb03fd7e1107f8052644","children":[{"type":"article","name":"7. Document and records management","id":"fe107b63e5120b5912d108b1124ee53b","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#7._Document_and_records_management"},{"type":"article","name":"8. Personnel and resource management","id":"e4cd57c94f774a5adcaa21560153afd3","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#8._Personnel_and_resource_management"},{"type":"article","name":"9. Compliance management","id":"643bd0275635c7b46f0a0cffc057e344","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#9._Compliance_management"},{"type":"article","name":"10. 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Instrument data capture and control","id":"8ddfffdf1743f9bdabc3c36d66534bfe","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#13._Instrument_data_capture_and_control"},{"type":"article","name":"14. Standard and reagent management","id":"7eccd67f6b726fbe47620b9bb6666fb0","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#14._Standard_and_reagent_management"},{"type":"article","name":"15. Inventory management","id":"0bc97d000872aaec451f3f49b4f26857","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#15._Inventory_management"},{"type":"article","name":"16. Investigation and quality management","id":"ab7fdb29588f2f1b80e4f3e12d7dd861","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Maintaining_laboratory_workflow_and_operations#16._Investigation_and_quality_management"}]},{"type":"chapter","name":"4. Technology and performance improvements","id":"28bc65e5330808256a5eb80e8f147dd7","children":[{"type":"article","name":"17. Instrument data systems functions","id":"fab185a3238d6b91f6a4de4003c98680","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#17._Instrument_data_systems_functions"},{"type":"article","name":"18. Systems integration","id":"29ba7833bcdbcad96b34ffbfce7cbc23","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Technology_and_performance_improvements#18._Systems_integration"},{"type":"article","name":"19. 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Security and integrity of systems and operations","id":"7830158c6643899dd8f459d3cee38a1b","children":[{"type":"article","name":"22. Data integrity","id":"89117ffb5f5c45e6c58390fd71119767","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#22._Data_integrity"},{"type":"article","name":"23. Configuration management","id":"14c1d5a48d0eb9c071c15fd69d497a80","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#23._Configuration_management"},{"type":"article","name":"24. System validation and commission","id":"d5cc68f93e213baf479f862b1dabd159","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#24._System_validation_and_commission"},{"type":"article","name":"25. System administration","id":"9515befc43a8b2f2d37dfd402051cbe8","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#25._System_administration"},{"type":"article","name":"26. Cybersecurity","id":"61d27181a0110b64e94d66635bc8243e","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#26._Cybersecurity"},{"type":"article","name":"27. Information privacy","id":"dc1cdf3e375b6de9f777812312d2e578","pageUrl":"https:\/\/www.cannaqa.wiki\/index.php?title=RefWork:LIMSpec_for_Cannabis_Testing\/Security_and_integrity_of_systems_and_operations#27._Information_privacy"}]},{"type":"chapter","name":"6. 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