{"ID":107661,"post_author":"9412100","post_date":"2023-05-16 18:12:21","post_date_gmt":"0000-00-00 00:00:00","post_content":"","post_title":"LIMS Selection Guide for Manufacturing Quality Control","post_excerpt":"","post_status":"draft","comment_status":"closed","ping_status":"closed","post_password":"","post_name":"","to_ping":"","pinged":"","post_modified":"2023-05-16 18:12:21","post_modified_gmt":"2023-05-16 22:12:21","post_content_filtered":"","post_parent":0,"guid":"https:\/\/www.limsforum.com\/?post_type=ebook&p=107661","menu_order":0,"post_type":"ebook","post_mime_type":"","comment_count":"0","filter":"","holland":null,"_ebook_metadata":{"enabled":"on","private":"0","guid":"D559F245-088B-42D0-B640-10DC4033631E","title":"LIMS Selection Guide for Manufacturing Quality Control","subtitle":"First Edition","cover_theme":"nico_8","cover_image":"https:\/\/www.limsforum.com\/wp-content\/plugins\/rdp-ebook-builder\/pl\/cover.php?cover_style=nico_8&subtitle=First+Edition&editor=Shawn+Douglas&title=LIMS+Selection+Guide+for+Manufacturing+Quality+Control&title_image=https%3A%2F%2Fs3.limsforum.com%2Fwww.limsforum.com%2Fwp-content%2Fuploads%2FBattery_Manufacturing_Lab_50954228316-scaled.jpg&publisher=LabLynx+Press","editor":"Shawn Douglas","publisher":"LabLynx Press","author_id":"26","image_url":"","items":{"597876f8d548775f68f71303f49964fb_type":"article","597876f8d548775f68f71303f49964fb_title":"A8. LIMSpec in Microsoft Word format","597876f8d548775f68f71303f49964fb_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/LIMSpec_in_Microsoft_Word_format","597876f8d548775f68f71303f49964fb_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/LIMSpec in Microsoft Word formatFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nA8. LIMSpec in Microsoft Word format \nMicrosoft Excel is often used as a tool to document requirements specifications. However, one downside to Microsoft Excel is its inability to handle multiple hyperlinks in the same cell. If you've looked over the LIMSpec in Appendix 1, you've likely noticed there are multiple hyperlinks to regulations, specifications, and guidance documents in the first column of the tables. Translating these wiki-based documents to Excel makes for a challenge when trying to maintain those hyperlinks. As they add value to not only your laboratory's requirements research but also to vendors' understanding of the sources for your requirements, it was decided the hyperlinks should be maintained in any portable version. As such, a Microsoft Word version was created.\nYou can download a copy of the Microsoft Word version of LIMSpec from LIMSwiki by going to File:LIMSpec for Manufacturing-based Labs v1.0.docx, right-clicking the URL under the white box, and selecting \"Save link as...\" (Alternatively, you can just click the link, open the file, and then save it.) A compromise was made between keeping the hyperlinks in the first column readable and leaving enough room in the third column for a vendor to provide a response. This response space admittedly may be a limiting factor for vendors wanting to include screenshots. If this situation arises, you may encourage the vendor to select the entire first column and delete it, then widening the response column.\nNote that this downloadable version of LIMSpec is released under the same licensing terms as this guide. Please see the first paragraph of the download for more details.\n\r\n\n\nCitation information for this chapter \nChapter: Appendix 1. Blank LIMSpec template for manufacturing labs\nTitle: LIMS Selection Guide for Manufacturing Quality Control\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: May 2023\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/LIMSpec_in_Microsoft_Word_format\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/LIMSpec_in_Microsoft_Word_format<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:11.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed once.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","597876f8d548775f68f71303f49964fb_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_LIMSpec_in_Microsoft_Word_format rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_LIMSpec_in_Microsoft_Word_format skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/LIMSpec in Microsoft Word format<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"A8._LIMSpec_in_Microsoft_Word_format\">A8. LIMSpec in Microsoft Word format<\/span><\/h2>\n<p>Microsoft Excel is often used as a tool to document requirements specifications. However, one downside to Microsoft Excel is its inability to handle multiple hyperlinks in the same cell. If you've looked over the LIMSpec in Appendix 1, you've likely noticed there are multiple hyperlinks to regulations, specifications, and guidance documents in the first column of the tables. Translating these wiki-based documents to Excel makes for a challenge when trying to maintain those hyperlinks. As they add value to not only your laboratory's requirements research but also to vendors' understanding of the sources for your requirements, it was decided the hyperlinks should be maintained in any portable version. As such, a Microsoft Word version was created.\n<\/p><p>You can download a copy of the Microsoft Word version of LIMSpec from LIMSwiki by going to <a href=\"https:\/\/www.limswiki.org\/index.php\/File:LIMSpec_for_Manufacturing-based_Labs_v1.0.docx\" title=\"File:LIMSpec for Manufacturing-based Labs v1.0.docx\" class=\"wiki-link\" data-key=\"7d0267a925f9103d672e1acb3dd56b6d\">File:LIMSpec for Manufacturing-based Labs v1.0.docx<\/a>, right-clicking the URL under the white box, and selecting \"Save link as...\" (Alternatively, you can just click the link, open the file, and then save it.) A compromise was made between keeping the hyperlinks in the first column readable and leaving enough room in the third column for a vendor to provide a response. This response space admittedly may be a limiting factor for vendors wanting to include screenshots. If this situation arises, you may encourage the vendor to select the entire first column and delete it, then widening the response column.\n<\/p><p>Note that this downloadable version of LIMSpec is released under the same licensing terms as this guide. Please see the first paragraph of the download for more details.\n<\/p><p><br \/>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: Appendix 1. Blank LIMSpec template for manufacturing labs\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for Manufacturing Quality Control<\/i>\n<\/p><p><b>Edition<\/b>: First Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: May 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230516221108\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.060 seconds\nReal time usage: 0.068 seconds\nPreprocessor visited node count: 10\/1000000\nPost\u2010expand include size: 1710\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 3\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 22.098 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/LIMSpec_in_Microsoft_Word_format\n100.00% 22.098 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14198-0!canonical and timestamp 20230516221108 and revision id 52023. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/LIMSpec_in_Microsoft_Word_format\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/LIMSpec_in_Microsoft_Word_format<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","597876f8d548775f68f71303f49964fb_images":[],"597876f8d548775f68f71303f49964fb_timestamp":1684275146,"2d050e46992605c76dc92938bd5bfd39_type":"article","2d050e46992605c76dc92938bd5bfd39_title":"A7. Putting those requirements to practical use and caveats","2d050e46992605c76dc92938bd5bfd39_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use","2d050e46992605c76dc92938bd5bfd39_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Putting LIMSpec to UseFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n\r\n\n\nA7. Putting those requirements to practical use and caveats \nThe LIMSpec covered laboratory informatics requirements organized into five broad categories, which are heavily influenced by the functional requirements checklist and Figure 3 of ASTM E1578-18 Standard Guide for Laboratory Informatics. However, the requirements listed prior are all based on not just the ASTM E1578 standard but also a wide variety of other standards, regulations, guidance documents, and standardized procedures (hereon referred to as \"sources\"). That ultimately means a foundational reasoning is provided for each requirement, not necessarily a \"just because I want it\" reasoning. As foundational requirements, this LIMSpec should thus operate as an excellent starting point for building your own software requirements specification or for researching the best laboratory informatics solution for your laboratory. \nSoftware developer considerations \nWhat does that mean for you? How can you best use this document? If you're a software developer for the laboratory industry, many of the sources referenced in these requirements should already be familiar to you. However, some of them may not be, and you'll probably want to at least familiarize yourself with them. Additionally, if you're developing a generic laboratory information management system (LIMS) or some other informatics solution, not tailored to a particular industry, most everything in chapters two, three, five, and six should largely be applicable to what you're doing with your commercial off-the-shelf (COTS) software solution. Definitely review the requirements items listed there and make sure the most important ones are part of your own software requirements specification. If the software solution you're developing is tailored to a particular industry (e.g., clinical or public health, pharmaceutical development, or heavy metals testing), you'll also want to examine chapter four. If you don't see many requirements for your industry listed (see the \"Caveats\" section later), you'll probably have additional research to conduct to see what additional sources will affect how you develop the functional and, particularly, non-functional requirements. \n\nBuyer considerations \nIf you're a potential buyer of a laboratory informatics solution, this LIMSpec is also useful to you. Perhaps you know a bit about your laboratory's workflow and a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed. Reviewing the five broad categories of requirements may be necessary to help further inform you regarding what's vital in regards to what a laboratory informatics solution should be capable of. Additionally, you can then use these requirements as a base for your laboratory's own requirements list. Using the categories and their subdivisions, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by the LIMSpec requirements. As you review the various options available to you and narrow down your search, your own list of requirements can be used as both as a personal checklist and as a requirements list you hand over to the vendor you query.\n\nSoftware vendor selection \nThat said, the requirements you hand off to the vendor should be discussed a bit more. Software vendor selection can at times be a tedious yet necessary process, one which requires careful planning and best practices. This topic has been written about by both software developers and end users alike, and their experiences should play a role in how you select a vendor. What follows is bullet-pointed advice as offered by some of those developers and end users.[1][2][3][4][5][6][7][8]\n\nHave a clear business case and build your business needs into your laboratory's requirements.\nBe mindful of how detailed you get with your own business-based requirements and what you initially hand off to a vendor. If you're too specific with too many requirements, you may have trouble finding a vendor that matches up. Start with the essentials that involve your laboratory's processes, regulations, integrations, reporting, service needs, etc. As this LIMSpec is foundation-based, you have a good starting point in that regard. You can always get more detailed with requirements as you narrow down vendors.\nAs discussed briefly in the introduction, you'll need to prioritize your needs somewhere between \"critical\" and \"nice to have.\" The LIMSpec's requirements are largely critical for most purposes and can be marked as such. The requirements you add will have to be prioritized more carefully.\nYou'll also want to perform some informal third-party information gathering about the vendors. Are reviews of the vendors trustworthy? Have peers had any interactions and success with the vendor? Does the vendor have the ability to scale to meet your needs?\nSchedule demonstrations of programs that seem like strong initial candidates. Make sure there is a question and answer session afterwards, and perform a post-demo evaluation.\nA formal request for proposal (RFP) may or may not be necessary, depending on the level of information you acquire prior. However, formally requesting pricing and clarification of maintenance and additional service costs is useful. Just don't let price be the only thing that guides you.\nConsider some of the intangibles. Does the vendor genuinely seem interested in your business and its needs? Do they communicate well and promptly? Do they seem flexible and able to accommodate a few special case requirements?\nBe sure to consider future needs as you anticipate potential laboratory expansion.\nDon't be afraid to choose a consultant to help you with the vendor selection process.\nCaveats \nFirst, note that this LIMSpec is still an evolving entity. Standards change. Regulations change. Procedures also change with such standards and regulations. That means that as those foundational characteristics shift, this set of requirements will have to also evolve. As such, do your homework and don't take everything you see here as fixed law. If you're responsible for investigating and\/or purchasing a laboratory informatics system, be sure you have at least some familiarity with the primary industry your laboratory serves, and by extension the regulations and standards that affect it. \nSecond, the number of industry-specific applications of laboratory informatics software continues to grow, and with it also the regulations and standards that affect those specialty laboratories. As such, some industry-specific requirements may have been missed for lack of or too expensive public-facing sources. As mentioned with the first caveat, this version of LIMSpec is evolving, and as industry experts and researchers are able to provide additional feedback on this document, it will surely grow with more relevant sources. In other words, don't consider this complete, particularly if you're in a specialized laboratory industry. You may have to add more items based on you industry knowledge and insights.\n\nReferences \n\n\n\u2191 Pearce, O. (21 June 2016). \"Software Vendor Selection: How to Define Your Requirements\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements . Retrieved 07 December 2022 .   \n \n\n\u2191 Pearce, O. (23 June 2016). \"Software Vendor Selection: Finding the Right Vendor\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor . Retrieved 07 December 2022 .   \n \n\n\u2191 Pearce, O. (28 June 2016). \"Software Vendor Selection: The Pitfalls and Successes of Vendor Demos\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations . Retrieved 07 December 2022 .   \n \n\n\u2191 Pearce, O. (5 July 2016). \"Software Vendor Selection: Requesting Proposals & Quotes\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes . Retrieved 07 December 2022 .   \n \n\n\u2191 Persaud, D. (4 February 2016). \"Business Requirements Gathering for Enterprise Software Selection\". SelectHub Blog. Abuyo, Inc. https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 Lichtenberger, A. (23 July 2012). \"Six Steps for a Successful Vendor Selection\". ITIL.org. https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 Poon, L. (29 May 2015). \"Insider\u2019s Guide to LIMS Selection\". Genologics Blog. GenoLogics Life Sciences Software Inc. https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/ . Retrieved 20 September 2019 .   \n[dead link ] \n\n\u2191 \"How to Select an ELN for Biology R&D\". Benchling, Inc. https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf . Retrieved 07 December 2022 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:10.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed once.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","2d050e46992605c76dc92938bd5bfd39_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Putting_LIMSpec_to_Use rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Putting_LIMSpec_to_Use skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Putting LIMSpec to Use<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<p><br \/>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"A7._Putting_those_requirements_to_practical_use_and_caveats\">A7. Putting those requirements to practical use and caveats<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Requirements_Allocation_Sheet.jpg\" class=\"image wiki-link\" data-key=\"750f6faf620baf76955d7ed0f7c86197\"><img alt=\"Requirements Allocation Sheet.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/c\/cf\/Requirements_Allocation_Sheet.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>The LIMSpec covered <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> requirements organized into five broad categories, which are heavily influenced by the functional requirements checklist and Figure 3 of <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> <i>Standard Guide for Laboratory Informatics<\/i>. However, the requirements listed prior are all based on not just the ASTM E1578 standard but also a wide variety of other standards, regulations, guidance documents, and standardized procedures (hereon referred to as \"sources\"). That ultimately means a foundational reasoning is provided for each requirement, not necessarily a \"just because I want it\" reasoning. As foundational requirements, this LIMSpec should thus operate as an excellent starting point for building your own software requirements specification or for researching the best laboratory informatics solution for your <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a>. \n<\/p><h3><span class=\"mw-headline\" id=\"Software_developer_considerations\">Software developer considerations<\/span><\/h3>\n<p>What does that mean for you? How can you best use this document? If you're a software developer for the laboratory industry, many of the sources referenced in these requirements should already be familiar to you. However, some of them may not be, and you'll probably want to at least familiarize yourself with them. Additionally, if you're developing a generic <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS) or some other informatics solution, not tailored to a particular industry, most everything in chapters two, three, five, and six should largely be applicable to what you're doing with your commercial off-the-shelf (COTS) software solution. Definitely review the requirements items listed there and make sure the most important ones are part of your own software requirements specification. If the software solution you're developing is tailored to a particular industry (e.g., clinical or public health, pharmaceutical development, or heavy metals testing), you'll also want to examine chapter four. If you don't see many requirements for your industry listed (see the \"Caveats\" section later), you'll probably have additional research to conduct to see what additional sources will affect how you develop the functional and, particularly, non-functional requirements. \n<\/p>\n<h3><span class=\"mw-headline\" id=\"Buyer_considerations\">Buyer considerations<\/span><\/h3>\n<p>If you're a potential buyer of a laboratory informatics solution, this LIMSpec is also useful to you. Perhaps you know a bit about your laboratory's workflow and a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed. Reviewing the five broad categories of requirements may be necessary to help further inform you regarding what's vital in regards to what a laboratory informatics solution should be capable of. Additionally, you can then use these requirements as a base for your laboratory's own requirements list. Using the categories and their subdivisions, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by the LIMSpec requirements. As you review the various options available to you and narrow down your search, your own list of requirements can be used as both as a personal checklist and as a requirements list you hand over to the vendor you query.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Software_vendor_selection\">Software vendor selection<\/span><\/h4>\n<p>That said, the requirements you hand off to the vendor should be discussed a bit more. Software vendor selection can at times be a tedious yet necessary process, one which requires careful planning and best practices. This topic has been written about by both software developers and end users alike, and their experiences should play a role in how you select a vendor. What follows is bullet-pointed advice as offered by some of those developers and end users.<sup id=\"rdp-ebb-cite_ref-PearceSoftware16_1-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PearceSoftware16-2_2-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-2-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PearceSoftware16-3_3-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-3-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PearceSoftware16-4_4-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-4-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PersaudBusiness16_5-0\" class=\"reference\"><a href=\"#cite_note-PersaudBusiness16-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LichtenbergerSix12_6-0\" class=\"reference\"><a href=\"#cite_note-LichtenbergerSix12-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PoonInsider15_7-0\" class=\"reference\"><a href=\"#cite_note-PoonInsider15-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BenchlingHowTo_8-0\" class=\"reference\"><a href=\"#cite_note-BenchlingHowTo-8\">[8]<\/a><\/sup>\n<\/p>\n<ul><li>Have a clear business case and build your business needs into your laboratory's requirements.<\/li>\n<li>Be mindful of how detailed you get with your own business-based requirements and what you initially hand off to a vendor. If you're too specific with too many requirements, you may have trouble finding a vendor that matches up. Start with the essentials that involve your laboratory's processes, regulations, integrations, reporting, service needs, etc. As this LIMSpec is foundation-based, you have a good starting point in that regard. You can always get more detailed with requirements as you narrow down vendors.<\/li>\n<li>As discussed briefly in the introduction, you'll need to prioritize your needs somewhere between \"critical\" and \"nice to have.\" The LIMSpec's requirements are largely critical for most purposes and can be marked as such. The requirements you add will have to be prioritized more carefully.<\/li>\n<li>You'll also want to perform some informal third-party information gathering about the vendors. Are reviews of the vendors trustworthy? Have peers had any interactions and success with the vendor? Does the vendor have the ability to scale to meet your needs?<\/li>\n<li>Schedule demonstrations of programs that seem like strong initial candidates. Make sure there is a question and answer session afterwards, and perform a post-demo evaluation.<\/li>\n<li>A formal request for proposal (RFP) may or may not be necessary, depending on the level of information you acquire prior. However, formally requesting pricing and clarification of maintenance and additional service costs is useful. Just don't let price be the only thing that guides you.<\/li>\n<li>Consider some of the intangibles. Does the vendor genuinely seem interested in your business and its needs? Do they communicate well and promptly? Do they seem flexible and able to accommodate a few special case requirements?<\/li>\n<li>Be sure to consider future needs as you anticipate potential laboratory expansion.<\/li>\n<li>Don't be afraid to choose a consultant to help you with the vendor selection process.<\/li><\/ul>\n<h3><span class=\"mw-headline\" id=\"Caveats\">Caveats<\/span><\/h3>\n<p>First, note that this LIMSpec is still an evolving entity. Standards change. Regulations change. Procedures also change with such standards and regulations. That means that as those foundational characteristics shift, this set of requirements will have to also evolve. As such, do your homework and don't take everything you see here as fixed law. If you're responsible for investigating and\/or purchasing a laboratory informatics system, be sure you have at least some familiarity with the primary industry your laboratory serves, and by extension the regulations and standards that affect it. \n<\/p><p>Second, the number of industry-specific applications of laboratory informatics software continues to grow, and with it also the regulations and standards that affect those specialty laboratories. As such, some industry-specific requirements may have been missed for lack of or too expensive public-facing sources. As mentioned with the first caveat, this version of LIMSpec is evolving, and as industry experts and researchers are able to provide additional feedback on this document, it will surely grow with more relevant sources. In other words, don't consider this complete, particularly if you're in a specialized laboratory industry. You may have to add more items based on you industry knowledge and insights.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-PearceSoftware16-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (21 June 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements\" target=\"_blank\">\"Software Vendor Selection: How to Define Your Requirements\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+How+to+Define+Your+Requirements&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=21+June+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-defining-your-requirements&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PearceSoftware16-2-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16-2_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (23 June 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor\" target=\"_blank\">\"Software Vendor Selection: Finding the Right Vendor\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+Finding+the+Right+Vendor&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=23+June+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-finding-the-right-vendor&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PearceSoftware16-3-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16-3_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (28 June 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations\" target=\"_blank\">\"Software Vendor Selection: The Pitfalls and Successes of Vendor Demos\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+The+Pitfalls+and+Successes+of+Vendor+Demos&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=28+June+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-conducting-demonstrations&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PearceSoftware16-4-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16-4_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (5 July 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes\" target=\"_blank\">\"Software Vendor Selection: Requesting Proposals & Quotes\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+Requesting+Proposals+%26+Quotes&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=5+July+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-requesting-proposals-quotes&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PersaudBusiness16-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PersaudBusiness16_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Persaud, D. (4 February 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/\" target=\"_blank\">\"Business Requirements Gathering for Enterprise Software Selection\"<\/a>. <i>SelectHub Blog<\/i>. Abuyo, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/\" target=\"_blank\">https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Business+Requirements+Gathering+for+Enterprise+Software+Selection&rft.atitle=SelectHub+Blog&rft.aulast=Persaud%2C+D.&rft.au=Persaud%2C+D.&rft.date=4+February+2016&rft.pub=Abuyo%2C+Inc&rft_id=https%3A%2F%2Fwww.selecthub.com%2Fmiscellaneous%2Ftechnology-selection%2Fbusiness-requirements-gathering-enterprise-software-selection%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LichtenbergerSix12-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LichtenbergerSix12_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Lichtenberger, A. (23 July 2012). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/\" target=\"_blank\">\"Six Steps for a Successful Vendor Selection\"<\/a>. <i>ITIL.org<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/\" target=\"_blank\">https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Six+Steps+for+a+Successful+Vendor+Selection&rft.atitle=ITIL.org&rft.aulast=Lichtenberger%2C+A.&rft.au=Lichtenberger%2C+A.&rft.date=23+July+2012&rft_id=https%3A%2F%2Fblog.itil.org%2F2012%2F07%2Fsix-steps-for-a-successful-vendor-selection%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PoonInsider15-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PoonInsider15_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Poon, L. (29 May 2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/\" target=\"_blank\">\"Insider\u2019s Guide to LIMS Selection\"<\/a>. <i>Genologics Blog<\/i>. GenoLogics Life Sciences Software Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/\" target=\"_blank\">https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 20 September 2019<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Insider%E2%80%99s+Guide+to+LIMS+Selection&rft.atitle=Genologics+Blog&rft.aulast=Poon%2C+L.&rft.au=Poon%2C+L.&rft.date=29+May+2015&rft.pub=GenoLogics+Life+Sciences+Software+Inc&rft_id=https%3A%2F%2Fwww.genologics.com%2Fblog%2Finsiders-guide-to-lims-selection%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<sup class=\"noprint Inline-Template\"><span style=\"white-space: nowrap;\">[<i><a href=\"https:\/\/en.wikipedia.org\/wiki\/Wikipedia:Link_rot\" class=\"extiw wiki-link\" title=\"wikipedia:Wikipedia:Link rot\" data-key=\"8e73a2ff6f82d88817bdd8ee8b302ab7\"><span title=\" Dead link since December 2022\">dead link<\/span><\/a><\/i>]<\/span><\/sup><\/span>\n<\/li>\n<li id=\"cite_note-BenchlingHowTo-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BenchlingHowTo_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf\" target=\"_blank\">\"How to Select an ELN for Biology R&D\"<\/a>. Benchling, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf\" target=\"_blank\">https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+to+Select+an+ELN+for+Biology+R%26D&rft.atitle=&rft.pub=Benchling%2C+Inc&rft_id=https%3A%2F%2Fbenchling.com%2Fstatic%2Fdocs%2Fresources%2Feln-for-biology-rnd.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230516221001\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.415 seconds\nReal time usage: 0.597 seconds\nPreprocessor visited node count: 5820\/1000000\nPost\u2010expand include size: 48191\/2097152 bytes\nTemplate argument size: 15752\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 13080\/5000000 bytes\nLua time usage: 0.110\/7 seconds\nLua virtual size: 5349376\/52428800 bytes\nLua estimated memory usage: 0 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 562.508 1 -total\n 96.92% 545.189 1 Template:Reflist\n 57.88% 325.584 1 Template:Dead_link\n 56.65% 318.676 1 Template:Fix\n 47.14% 265.170 1 Template:Category_handler\n 30.32% 170.577 8 Template:Cite_web\n 27.10% 152.417 8 Template:Citation\/core\n 8.17% 45.985 1 Template:Cat_handler\n 6.74% 37.889 7 Template:Date\n 3.06% 17.207 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14197-0!canonical and timestamp 20230516221000 and revision id 52022. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","2d050e46992605c76dc92938bd5bfd39_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/c\/cf\/Requirements_Allocation_Sheet.jpg"],"2d050e46992605c76dc92938bd5bfd39_timestamp":1684275146,"8dba7922c519f23896ea896ed1a6beab_type":"article","8dba7922c519f23896ea896ed1a6beab_title":"A6. Security and integrity of systems and operations","8dba7922c519f23896ea896ed1a6beab_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Security_and_integrity_of_systems_and_operations","8dba7922c519f23896ea896ed1a6beab_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Security and integrity of systems and operationsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n\r\n\n\nA6. Security and integrity of systems and operations \nNote: These categories cover what ASTM E1578-18 largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.\n\n31. Data integrity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-17-1\r\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\nWHO Technical Report Series, #996, Annex 5, 9.1\n\n31.1 System functionality should support ALCOA principles.\n\n\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nASTM E1578-18 E-17-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nA2LA C211 4.13.2.3\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nNIST 800-53, Rev. 5, SI-12\n\n\n31.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.190\r\n\n42 CFR Part 93.305\r\n\n42 CFR Part 93.310\r\n\nASTM E1578-18 E-17-3\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nOECD GLP Principles 10\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n31.3 The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n\n\n\n7 CFR Part 91.30\r\n\n7 CFR Part 331.17 (c)\r\n\n9 CFR Part 2.35\r\n\n9 CFR Part 121.17 (c)\r\n\n10 CFR Part 20.2103\u201310\r\n\n10 CFR Part 30.34 (g)\r\n\n10 CFR Part 30.51\u20132\r\n\n21 CFR Part 1.1154 (a)\r\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 106.100 (n)\r\n\n21 CFR Part 112.164\r\n\n21 CFR Part 114.100 (e)\r\n\n21 CFR Part 117.315\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.9\r\n\n21 CFR Part 129.80 (h)\r\n\n21 CFR Part 211.180\r\n\n21 CFR Part 212.110 (c)\r\n\n21 CFR Part 225.42 (b-8)\r\n\n21 CFR Part 225.58 (c\u2013d)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.42 (a)\r\n\n21 CFR Part 226.58 (f)\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 226.115\r\n\n21 CFR Part 312.57\r\n\n21 CFR Part 312.62\r\n\n21 CFR Part 507.208\r\n\n21 CFR Part 606.160 (d)\r\n\n21 CFR Part 812.140 (d)\r\n\n21 CFR Part 820.180 (b)\r\n\n29 CFR Part 1910.120 (f)(8)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n40 CFR Part 141.33\r\n\n40 CFR Part 141.722\r\n\n40 CFR Part 262.11 (f)\r\n\n40 CFR Part 262.40\r\n\n40 CFR Part 262.213\r\n\n40 CFR Part 704 Subpart A\r\n\n40 CFR Part 717.15 (d)\r\n\n42 CFR Part 73.17 (c)\r\n\n42 CFR Part 93.313 (h)\r\n\n42 CFR Part 93.317\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1283\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164.316\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C223 5.4\r\n\nA2LA C223 5.9\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.3.2\r\n\nABFT Accreditation Manual Sec. E-33\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.6\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E2.1\r\n\nAIHA-LAP Policies 2022 2A.7.5.1\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7\r\n\nASTM E1578-18 E-17-4\r\n\nBRC GSFS, Issue 8, 3.3.2\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy 5.4.6\u20137\r\n\nCJIS Security Policy 5.5.2.1\r\n\nCLSI QMS22 2.8.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.4\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nEPA 815-R-05-004 Chap. III, Sec. 15\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.9.18\r\n\nEPA ERLN Laboratory Requirements 4.11.17\r\n\nEPA QA\/G-5 2.1.9\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3\r\n\nICH GCP 4.9.5\r\n\nIFS Food 7, Part 2, 2.1.2.2\r\n\nIFS PACsecure 2, Part 2, 2.1.2.2\r\n\nISO 15189:2012 4.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 5, AT-4\r\n\nNIST 800-53, Rev. 5, AU-11 and AU-11(1)\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 10\r\n\nOSHA 1910.1020(d)(1)(i\u2013ii)\r\n\nOSHA 1910.1450(j)(2)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP 5.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c\r\n\nUSDA Sampling Procedures for PDP 6.5\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\u20139\r\n\nWHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1\n\n\n31.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n\n\nASTM E1578-18 E-17-6\r\nCJIS Security Policy 5.4.4\r\nNIST 800-53, Rev. 5, AU-8\r\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n31.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 E-17-7\r\nCJIS Security Policy 5.6.1\n\n31.6 The system shall require each and every user to be assigned a unique user ID.\n\n\n\nASTM E1578-18 E-17-8\r\n\n21 CFR Part 11.10 (e)\r\n\nCJIS Security Policy 5.4.5\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-9\n\n\n31.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n\n\nCJIS Security Policy 5.4.2\r\nNIST 800-53, Rev. 5, AU-5\r\nNIST 800-53, Rev. 5, SI-4\n\n31.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n\n\n\n32. Configuration management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-1-1\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.1 The system shall provide tools to enter and manage user-configurable lookup or master data.\n\n\nASTM E1578-18 S-1-2\n\n32.2 The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n\n\n45 CFR Part 162.1002\r\nUSDA Sampling Procedures for PDP 6.3.2\n\n32.3 The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n\n\nASTM E1578-18 S-1-3\n\n32.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n\n\nASTM E1578-18 S-1-4\n\n32.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n\n\n21 CFR Part 211.100 (b)\r\n21 CFR Part 211.160 (a)\n\n32.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 3.2000\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nASTM E1578-18 S-1-5\r\n\nNIST 800-53, Rev. 5, AU-10\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n\n\nASTM E1578-18 S-1-6\n\n32.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n\n\nASTM E1578-18 S-1-7\n\n32.9 The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n\n\nASTM E1578-18 S-1-8\n\n32.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n\n\n21 CFR Part 211.68\r\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 S-1-9\n\n32.11 The system should allow authorized personnel to perform revision control of lookup or master data.\n\n\nASTM E1578-18 S-1-10\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.12 The system should provide a means for importing lookup or master data.\n\n\n\nAIHA-LAP Policies 2022 2A.7.8.4\r\n\nASTM E1578-18 S-1-11\r\n\nEPA ERLN Laboratory Requirements 4.11.6\r\n\nUSDA Data and Instrumentation for PDP 9.1\n\n\n32.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n\n\nASTM E1578-18 S-1-12\n\n32.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n\n\nASTM E1578-18 S-1-13\r\nEPA ERLN Laboratory Requirements 3.2.6\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n32.15 The system should provide a clear alert or notification upon entry of out-of-specification results.\n\n\nASTM E1578-18 S-1-14\n\n32.16 The system shall allow authorized personnel to update static and dynamic data.\n\n\nASTM E1578-18 S-1-15\n\n32.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.\n\n\nASTM E1578-18 S-1-17\r\nCJIS Security Policy 5.7.1\r\nNIST 800-53, Rev. 5, AC-6(1)\r\nNIST 800-53, Rev. 5, CM-7\n\n32.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n\n\nASTM E1578-18 S-1-18\r\nCAP Laboratory Accreditation Manual\n\n32.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n\n\nASTM E1578-18 S-1-19\n\n32.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n\n\n21 CFR Part 11.100 (a)\r\nASTM E1578-18 S-1-20\r\nE.U. Annex 11-14\r\nNIST 800-53, Rev. 5, CM-5(1)\r\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n32.21 The system should support rules governing electronic records and electronic signatures in regulated environments.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n10 CFR Part 20.2110\r\n\n10 CFR Part 30.51 (c-1\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\nA2LA C211 4.13.1.4\r\n\nA2LA C211 5.4.7.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.1\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nASTM E1578-18 S-1-16\r\n\nASTM E1578-18 S-1-21\r\n\nCJIS Security Policy 5.5.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nEPA ERLN Laboratory Requirements 4.9.4 and 4.9.14\r\n\nICH GCP 2.10\r\n\nISO\/IEC 17025:2017 4.2.1\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, CM-5 and CM-5(1)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n\n\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nCJIS Security Policy 5.5.2.2\u20133\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-2(11)\n\n\n32.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n\n\nASTM E1578-18 S-1-22\r\nNIST 800-53, Rev. 5, IA-2(10)\n\n32.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.6.1\r\n\nCLSI QMS22 2.4.2.2\r\n\nE.U. Annex 11-14\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.4\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n\n\n\n21 CFR Part 11.300 (a)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-4 and IA-5\n\n\n32.26 The system shall prevent the same combination of identification components from being used across more than one account.\n\n\n\n21 CFR Part 11.300 (b)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCLSI QMS22 2.4.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-5 and IA-5(1)\n\n\n32.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n\n\nCJIS Security Policy 5.6.3.1\r\nNIST 800-53, Rev. 5, AC-2(3)\r\nNIST 800-53, Rev. 5, IA-4 and IA-5(1)\r\nNIST 800-53, Rev. 5, PS-4\n\n32.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n\n\nCJIS Security Policy 5.5.2.2\r\nNIST 800-53, Rev. 5, AC-10\n\n32.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n\n\nCJIS Security Policy 5.5.4\r\nNIST 800-53, Rev. 5, AC-8\n\n32.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n\n\n\n21 CFR Part 11.300 (d)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\nA2LA C211 4.13.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.4.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n\n\n\n21 CFR Part 11.300 (d)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.5.3\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-7\n\n\n32.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n\n\n21 CFR Part 11.200 (a)\r\nASTM E1578-18 S-3-1\n\n32.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.200 (a)\r\n\n21 CFR Part 211.68 (b)\r\n\n21 CFR Part 211.188 (b-11)\r\n\n21 CFR Part 211.194 (a-7 and a-8)\r\n\n21 CFR Part 212.50 (c-10)\r\n\n42 CFR Part 73.11\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.6.3.2\r\n\nNIST 800-53, Rev. 5, IA-5\n\n\n32.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-1-25\r\n\nCJIS Security Policy 5.5.1\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\n\n\n32.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n\n\n\n21 CFR Part 11.100 (a)\r\n\n45 CFR Part 164.312\r\n\nASTM E1578-18 S-1-24\r\n\nE.U. Annex 11-14\r\n\nNIST 800-53, Rev. 5, AU-10 and AU-10(3)\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n\n\n21 CFR Part 11.100 (a)\r\nASTM E1578-18 S-1-24\r\nNIST 800-53, Rev. 5, AU-10 and AU-10(3)\n\n32.37 The system shall prevent the reuse or reassignment of a user's electronic signature.\n\n\n21 CFR Part 11.50\r\nE.U. Annex 11-14\n\n32.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n\n\n\nASTM E1578-18 S-1-26\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nCLSI QMS22 2.8.5.3\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.39 The system should provide a means to migrate static data into the system.\n\n\nNIST 800-53, Rev. 5, IA-5(1)\r\nCLSI QMS22 2.4.2\n\n32.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n\n\nNIST 800-53, Rev. 5, IA-6\n\n32.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n\n\n\n33. System validation and commission \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-2-1\r\nCJIS Security Policy Appendix G.8\r\nNIST 800-53, Rev. 5, SA-4(3)\n\n33.1 The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n\n\nASTM E1578-18 S-2-2\r\nNIST 800-53, Rev. 5, SA-4(2)\n\n33.2 The vendor should be willing to provide access to source code through a suitable escrow.\n\n\nASTM E1578-18 S-2-3\n\n33.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n\n\n\nA2LA C211 5.4.7.2\r\n\nASTM E1578-18 S-2-4\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.5\r\n\nNIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5\n\n\n33.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n\n\n\n21 CFR Part 11.10 (a)\r\n\n21 CFR Part 820.70 (i)\r\n\nA2LA C211 5.4.7.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-11\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)\r\n\nWHO Technical Report Series, #996, Annex 5, 10.2\n\n\n33.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n\n\nASTM E1578-18 S-2-2\r\nCLSI QMS22 2.5\r\nE.U. Annex 11-4\r\nWHO Technical Report Series, #996, Annex 5, 10.3\u20137\n\n33.6 The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n\n\n\n34. System administration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-5)\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.5.5\r\n\nCLSI QMS22 2.4.2\r\n\nNIST 800-53, Rev. 5, AC-11 and AC-12\n\n\n34.1 The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n\n\nASTM E1578-18 S-3-2\n\n34.2 The system should provide a means for modifying personnel data in a batch.\n\n\nASTM E1578-18 S-3-3\n\n34.3 The system should support the storage of standard and industry-specific data formats.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-7\r\n\nCJIS Security Policy 5.5.1\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy Appendix G.5\r\n\nCLSI QMS22 2.4.2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nISO 15189:2012 5.10.2\r\n\nISO\/IEC 17025:2017 7.8.7.1\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2 and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nNIST 800-53, Rev. 5, PS-4 and PS-5\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Administrative Procedures for the PDP 5.5.1.2\r\n\nWHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1\n\n\n34.4 The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n\n\nASTM E1578-18 S-3-8\n\n34.5 The vendor should provide maintenance agreements and support services for its applications and services.\n\n\nASTM E1578-18 S-3-9\r\nE.U. Annex 11-3.3\r\nNIST 800-53, Rev. 5, SA-16\r\nUSDA Administrative Procedures for the PDP 5.2.4\n\n34.6 The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (c)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.310\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.3\r\n\nABFT Accreditation Manual Sec. D-5\u2013D-8\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nCJIS Security Policy 5.5.2\r\n\nCJIS Security Policy 5.8.1\r\n\nEPA ERLN Laboratory Requirements 4.9.6\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Annex 11-12\r\n\nISO 15189:2012 5.10.2\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, MA-5\r\n\nNIST 800-53, Rev. 5, MP-2\r\n\nNIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\n\n\n34.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n\n\nCJIS Security Policy 5.5.1\n\n34.8 The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 S-3-10\n\n\n34.9 The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n42 CFR Part 73.11\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-11\r\n\nCJIS Security Policy 5.10.4.1\r\n\nCLSI QMS22 2.1.4\r\n\nCLSI QMS22 2.6.1\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 5, SI-2(5)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n34.10 The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n\n\nASTM E1578-18 S-3-12\n\n34.11 The system shall provide a means for migrating data to a new release upon system upgrade.\n\n\n21 CFR Part 1.1154 (b)\r\nASTM E1578-18 S-3-13\n\n34.12 The system should be expedient with the retrieval of stored items.\n\n\n\n21 CFR Part 11.10 (b)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nE.U. Annex 11-5\r\n\nE.U. Annex 11-8.1\n\n\n34.13 The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n\n\nASTM E1578-18 S-3-14\n\n34.14 The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n\n\nASTM E1578-18 S-3-15\r\nEPA ERLN Laboratory Requirements 4.9.13\r\nNIST 800-53, Rev. 5, CM-3(2)\r\nNIST 800-53, Rev. 5, SI-2\n\n34.15 The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n\n\n\n35. Cybersecurity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-9)\r\n\nASTM E1578-18 S-4-1\r\n\nCJIS Security Policy 5.6.4\r\n\nCJIS Security Policy 5.8.2.1\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nCLSI QMS22 2.2.3.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nNIST 800-53, Rev. 5, AC-17(2)\r\n\nNIST 800-53, Rev. 5, MA-4(6)\r\n\nNIST 800-53, Rev. 5, SC-8 and SC-8(1)\n\n\n35.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.6\r\n\nASTM E1578-18 S-4-2\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, CP-9(8)\r\n\nNIST 800-53, Rev. 5, SC-13 and SC-28(1)\n\n\n35.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\n\n\n42 CFR Part 493.1231\r\nCJIS Security Policy 5.6.2.2.1\r\nCLSI QMS22 2.4.2.2\r\nNIST 800-53, Rev. 5, AC-3\r\nNIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8\r\nNIST 800-53, Rev. 5, MA-4\n\n35.3 The system should be able to support multifactor authentication.\n\n\n45 CFR Part 170.202\r\n45 CFR Part 170.315 (h)\n\n35.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n\n\nNIST 800-53, Rev. 5, IA-7\n\n35.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n\n\nNIST 800-53, Rev. 5, SC-15\n\n35.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n\n\n\n36. Information privacy \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 164 Subpart E\r\nACMG Technical Standards for Clinical Genetics Laboratories G17.2\r\nASTM E1578-18 S-5-1\r\nCAP Laboratory Accreditation Manual\r\nNIST 800-53, Rev. 5, PT-2 and PT-2(2)\n\n36.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n\n\n\n10 CFR Part 20.2106 (d)\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164 Subpart C\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-5-2\r\n\nICH GCP 2.11\r\n\nNIST 800-53, Rev. 5, PT-2 and PT-2(2)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.3\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\n\n\n36.2 The system should be provisioned with enough security to automatically enforce verification mechanisms that prevent personally identifiable information in the system from being compromised.\n\n\n45 CFR Part 164.514\r\nACMG Technical Standards for Clinical Genetics Laboratories C5.5\r\nCAP Laboratory Accreditation Manual\r\nNIST 800-53, Rev. 5, SI-19\r\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3\n\n36.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n\n\n45 CFR Part 164 Subpart E\r\nNIST 800-53, Rev. 5, AC-6\r\nNIST 800-53, Rev. 5, SI-19\n\n36.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n\n\nNIST 800-53, Rev. 5, SI-19(7)\n\n36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n\n\nNIST 800-53, Rev. 5, PT-4 and PT-4(3)\n\n36.6 The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n\n\n\nReferences \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Security_and_integrity_of_systems_and_operations\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Security_and_integrity_of_systems_and_operations<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:09.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed once.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","8dba7922c519f23896ea896ed1a6beab_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Security_and_integrity_of_systems_and_operations rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Security_and_integrity_of_systems_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Security and integrity of systems and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<p><br \/>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"A6._Security_and_integrity_of_systems_and_operations\">A6. Security and integrity of systems and operations<\/span><\/h2>\n<p><b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.<\/b>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"31._Data_integrity\">31. Data integrity<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 9.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.1<\/b> System functionality should support ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.2<\/b> The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.305\" target=\"_blank\">42 CFR Part 93.305<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.310\" target=\"_blank\">42 CFR Part 93.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.3<\/b> The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.30\" target=\"_blank\">7 CFR Part 91.30<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.195\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (n)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.164<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.180\" target=\"_blank\">21 CFR Part 211.180<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 212.110 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42 (b-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.115\" target=\"_blank\">21 CFR Part 226.115<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.208<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120 (f)(8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.722\" target=\"_blank\">40 CFR Part 141.722<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.11\" target=\"_blank\">40 CFR Part 262.11 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.40\" target=\"_blank\">40 CFR Part 262.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.213\" target=\"_blank\">40 CFR Part 262.213<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\/subpart-A\" target=\"_blank\">40 CFR Part 704 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/717.15\" target=\"_blank\">40 CFR Part 717.15 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.313\" target=\"_blank\">42 CFR Part 93.313 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.317\" target=\"_blank\">42 CFR Part 93.317<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.316\" target=\"_blank\">45 CFR Part 164.316<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.4<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-11 and AU-11(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020(d)(1)(i\u2013ii)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(j)(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.4<\/b> The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.5<\/b> The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-7<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.6<\/b> The system shall require each and every user to be assigned a unique user ID.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.7<\/b> The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.8<\/b> The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"32._Configuration_management\">32. Configuration management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.1<\/b> The system shall provide tools to enter and manage user-configurable lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.2<\/b> The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.1002\" target=\"_blank\">45 CFR Part 162.1002<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.3.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.3<\/b> The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.4<\/b> The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.5<\/b> The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.6<\/b> The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.2000\" target=\"_blank\">40 CFR Part 3.2000<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.7<\/b> The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.8<\/b> The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.9<\/b> The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.10<\/b> The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.11<\/b> The system should allow authorized personnel to perform revision control of lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-10<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.12<\/b> The system should provide a means for importing lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.13<\/b> The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.14<\/b> The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.15<\/b> The system should provide a clear alert or notification upon entry of out-of-specification results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.16<\/b> The system shall allow authorized personnel to update static and dynamic data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.17<\/b> The system should allow workflow events and status changes to trigger one or more user-defined actions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.7.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(1)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.18<\/b> The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-18<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.19<\/b> The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-19<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.20<\/b> The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-20<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.21<\/b> The system should support rules governing electronic records and electronic signatures in regulated environments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2110\" target=\"_blank\">10 CFR Part 20.2110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51 (c-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5 and CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.22<\/b> The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(11)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.23<\/b> The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(10)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.24<\/b> The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.25<\/b> The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.26<\/b> The system shall prevent the same combination of identification components from being used across more than one account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5 and IA-5(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.27<\/b> The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(3)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5(1)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.28<\/b> The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.29<\/b> The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.30<\/b> The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.31<\/b> The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.32<\/b> The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.33<\/b> The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188 (b-11)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (a-7 and a-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (c-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.34<\/b> The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.35<\/b> The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.36<\/b> The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.37<\/b> The system shall prevent the reuse or reassignment of a user's electronic signature.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.50\" target=\"_blank\">21 CFR Part 11.50<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.38<\/b> When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.39<\/b> The system should provide a means to migrate static data into the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.40<\/b> The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.41<\/b> The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"33._System_validation_and_commission\">33. System validation and commission<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.1<\/b> The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.2<\/b> The vendor should be willing to provide access to source code through a suitable escrow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.3<\/b> The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.4<\/b> The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.5<\/b> The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.3\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.6<\/b> The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"34._System_administration\">34. System administration<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-11 and AC-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.1<\/b> The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.2<\/b> The system should provide a means for modifying personnel data in a batch.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.3<\/b> The system should support the storage of standard and industry-specific data formats.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2 and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4 and PS-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.4<\/b> The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.5<\/b> The vendor should provide maintenance agreements and support services for its applications and services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-9<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-3.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.6<\/b> The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-5\u2013D-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.7<\/b> The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.8<\/b> The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.9<\/b> The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2(5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.10<\/b> The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.11<\/b> The system shall provide a means for migrating data to a new release upon system upgrade.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.12<\/b> The system should be expedient with the retrieval of stored items.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.13<\/b> The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.14<\/b> The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-15<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-3(2)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>34.15<\/b> The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"35._Cybersecurity\">35. Cybersecurity<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.8.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-17(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4(6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-8 and SC-8(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.1<\/b> The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9(8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-13 and SC-28(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>35.2<\/b> The system should support database encryption and be capable of recording the encryption status of the data contained within.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.2.2.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.3<\/b> The system should be able to support multifactor authentication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.202\" target=\"_blank\">45 CFR Part 170.202<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (h)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.4<\/b> The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.5<\/b> The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SC-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>35.6<\/b> The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"36._Information_privacy\">36. Information privacy<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-2 and PT-2(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.1<\/b> The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2106\" target=\"_blank\">10 CFR Part 20.2106 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-C\" target=\"_blank\">45 CFR Part 164 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-5-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-2 and PT-2(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>36.2<\/b> The system should be provisioned with enough security to automatically enforce verification mechanisms that prevent personally identifiable information in the system from being compromised.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.3<\/b> The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\/subpart-E\" target=\"_blank\">45 CFR Part 164 Subpart E<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.4<\/b> The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-19(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.5<\/b> The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PT-4 and PT-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>36.6<\/b> The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<\/div>\n<!-- \nNewPP limit report\nCached time: 20230516220938\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.112 seconds\nReal time usage: 0.138 seconds\nPreprocessor visited node count: 518\/1000000\nPost\u2010expand include size: 161319\/2097152 bytes\nTemplate argument size: 24\/2097152 bytes\nHighest expansion depth: 7\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 59.561 1 -total\n 80.86% 48.160 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Security_and_integrity_of_systems_and_operations\n 18.80% 11.200 1 Template:Reflist\n 11.90% 7.090 1 Template:LIMSpec\/Configuration_management\n 11.73% 6.985 1 Template:LIMSpec\/Data_integrity\n 11.04% 6.573 1 Template:LIMSpec\/Information_privacy\n 9.61% 5.722 1 Template:LIMSpec\/System_validation_and_commission\n 9.21% 5.486 1 Template:LIMSpec\/Cybersecurity\n 8.75% 5.209 1 Template:LIMSpec\/System_administration\n 8.60% 5.121 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14196-0!canonical and timestamp 20230516220940 and revision id 52021. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Security_and_integrity_of_systems_and_operations\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Security_and_integrity_of_systems_and_operations<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","8dba7922c519f23896ea896ed1a6beab_images":[],"8dba7922c519f23896ea896ed1a6beab_timestamp":1684275145,"cf69a4c8871d66429a02b00b9913e6f6_type":"article","cf69a4c8871d66429a02b00b9913e6f6_title":"A5. Technology and performance improvements","cf69a4c8871d66429a02b00b9913e6f6_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Technology_and_performance_improvements","cf69a4c8871d66429a02b00b9913e6f6_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Technology and performance improvementsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n\r\n\n\nA5. Technology and performance improvements \nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.\n\n26. Instrument data systems functions \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-12-1\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.1 The system should be able to use an application programming interface or web services to communicate with instrument data systems.\r\n\n\n\nASTM E1578-18 E-12-2\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.2 The system should be capable of sending samples and test orders to instrument data systems.\n\n\n\nASTM E1578-18 E-12-3\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nCLSI AUTO15 2.0\r\n\nCLSI QMS22 2.2.2.5\r\n\nEPA ERLN Laboratory Requirements 4.9.16\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n26.3 The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.\n\n\nASTM E1578-18 E-12-4\r\nAPHL 2019 LIS Project Management Guidebook\r\nCLSI AUTO15 2.0\n\n26.4 The system should be capable of generically parsing instrument data to extract important sample details and results.\n\n\n\n27. Systems integration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.105 (a)\r\nASTM E1578-18 E-13-1\n\n27.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.\n\n\nASTM E1578-18 E-13-2\n\n27.2 The system should accurately communicate overall system status changes to external systems.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.190\r\n\nABFT Accreditation Manual C-15\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 E-13-3\r\n\nEPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 3.4\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n27.3 The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.51\r\n\n21 CFR Part 58.190\r\n\nABFT Accreditation Manual C-15\r\n\nASTM E1578-18 E-13-4\r\n\nCAP Laboratory Accreditation Manual\r\n\nEPA ERLN Laboratory Requirements 4.9.5\r\n\nE.U. Annex 11-17\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nOECD GLP Principles 3.4\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1\n\n\n27.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\n\n\nASTM E1578-18 E-13-5\n\n27.5 The system should feature a reliable, effective, and supported data storage system.\n\n\n\n21 CFR Part 1.1110\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\nASTM E1578-18 C-6-6\r\n\nASTM E1578-18 E-13-6\r\n\nCLSI QMS22 2.2.3.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\n\n\n27.6 The system should be able to interface directly with a third-party reporting tool.\n\n\nASTM E1578-18 E-13-7\n\n27.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\n\n\nASTM E1578-18 E-13-8\n\n27.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed.\n\n\nASTM E1578-18 E-13-9\n\n27.9 The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\n\n\nASTM E1578-18 E-13-10\n\n27.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data.\n\n\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 211.68 (b)\r\n\n21 CFR Part 820.180\r\n\n45 CFR Part 164.308\r\n\nA2LA C211 4.13.1.4\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.4\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 E-13-11\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.4.2\r\n\nCLSI QMS22 2.8.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\nEPA ERLN Laboratory Requirements 4.9.5 and 4.9.14\r\n\nEPA QA\/G-5 2.1.9\r\n\nE.U. Annex 11-7.2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 5, CP-9 and CP-10\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n27.11 The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure and encrypted from manipulation and loss.\n\n\nASTM E1578-18 E-13-12\n\n27.12 The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\n\n\nASTM E1578-18 E-13-13\n\n27.13 The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\n\n\nASTM E1578-18 E-13-14\n\n27.14 The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\n\n\n\nASTM E1578-18 E-13-15\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nE.U. Annex 11-5\r\n\nISO 15189:2012 5.10.3\n\n\n27.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.\n\n\nASTM E1578-18 E-13-16\n\n27.16 The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\n\n\nASTM E1578-18 E-13-17\n\n27.17 The system should be able to interface with an external enterprise resource planning system.\n\n\nASTM E1578-18 E-13-18\n\n27.18 The system should be capable of interfacing with enterprise middleware.\n\n\n\n28. Laboratory scheduling and capacity planning \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.25 (c)\r\nACMG Technical Standards for Clinical Genetics Laboratories B2\r\nASTM E1578-18 E-14-1\n\n28.1 The system should be able to accurately gauge and report test-based work capacity or throughput.\n\n\nASTM E1578-18 E-14-2\n\n28.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\n\n\nASTM E1578-18 E-14-3\n\n28.3 The system should provide a means for tasks to be scheduled and allocated against available resources.\n\n\n42 CFR Part 493.1274 (d)\n\n28.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.\n\n\n\n29. Lean laboratory and continuous improvement \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-15-1\n\n29.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\n\n\nASTM E1578-18 E-15-2\r\nFDA Hazard Analysis Critical Control Point Principle 1\n\n29.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points.\n\n\n21 CFR Part 211.42 (b)\r\nASTM E1578-18 E-15-3\r\nFDA Hazard Analysis Critical Control Point Principle 1\n\n29.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.\n\n\n\n30. Artificial intelligence and smart systems \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-16-1\n\n30.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\n\n\nASTM E1578-18 E-16-2\n\n30.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\n\n\nASTM E1578-18 E-16-3\n\n30.3 The system should support voice data capture and retrieval as smart laboratory assistance functions.\n\n\nASTM E1578-18 E-16-4\n\n30.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\n\n\nASTM E1578-18 E-16-5\r\nNIST 800-53, Rev. 5, MA-6(2)\n\n30.5 The system should support predictive maintenance routines for laboratory instruments and equipment.\n\n\nASTM E1578-18 E-16-6\n\n30.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\n\n\nASTM E1578-18 E-16-7\n\n30.7 The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\n\n\nASTM E1578-18 E-16-8\r\nCLSI QMS22 2.1.2.1\r\nISO 15189:2012 5.10.3\r\nNIST 800-53, Rev. 5, SI-4(5) and SI-4(7)\n\n30.8 The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 211.28\r\n\n21 CFR Part 211.46\r\n\n21 CFR Part 312.58 (b)\r\n\n21 CFR Part 312.69\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n45 CFR Part 164.310\r\n\nA2LA C211 5.3.4\r\n\nA2LA C211 5.4.7.2\r\n\nA2LA C223 5.3\r\n\nAAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1\r\n\nASTM E1492-11 4.1.8\r\n\nASTM E1492-11 4.4.2\r\n\nASTM E1578-18 E-16-9\r\n\nCJIS Security Policy 5.9.1.6\r\n\nCLSI QMS22 2.4.2\r\n\nEPA ERLN Laboratory Requirements 4.1.13\r\n\nEPA ERLN Laboratory Requirements 4.9.6\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 6.3.3\r\n\nISO\/IEC 17025:2017 6.3.4\r\n\nISO\/TS 22002-1:2009, 18.2\r\n\nISO\/TS 22002-4:2013, 4.15\r\n\nNIST 800-53, Rev. 5, MP-2\r\n\nNIST 800-53, Rev. 5, PE-6(1)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\nWHO Technical Report Series, #986, Annex 2, 9.5\r\n\nWHO Technical Report Series, #986, Annex 2, 12.8 and 12.18\n\n\n30.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\n\n\n42 CFR Part 493.1252\r\nASTM E1578-18 E-16-10\r\nISO 15189:2012 5.10.3\n\n30.10 The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 820.70 (c)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1252\r\n\n42 CFR Part 493.1278\r\n\nA2LA C211 5.3\r\n\nA2LA C223 5.3\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.3.1\u20132\r\n\nABFT Accreditation Manual Sec. E-22\r\n\nASTM E1578-18 E-16-11\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.3.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nISO 15189:2012 5.2.6\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 6.3.3\r\n\nISO\/IEC 17025:2017 6.3.4\r\n\nISO\/IEC 17025:2017 7.4.4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 10\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11\r\n\nWHO Technical Report Series, #986, Annex 2, 12.8 and 12.16\n\n\n30.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\n\n\n\nReferences \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Technology_and_performance_improvements\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Technology_and_performance_improvements<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:09.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed once.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","cf69a4c8871d66429a02b00b9913e6f6_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Technology_and_performance_improvements rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Technology_and_performance_improvements skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Technology and performance improvements<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<p><br \/>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"A5._Technology_and_performance_improvements\">A5. Technology and performance improvements<\/span><\/h2>\n<p><b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support core laboratory workflow, but in this case the dominant theme is additional technology that supports workflow, as well as requirements that improve overall laboratory performance.<\/b>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"26._Instrument_data_systems_functions\">26. Instrument data systems functions<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.1<\/b> The system should be able to use an application programming interface or web services to communicate with instrument data systems.<br \/>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.2<\/b> The system should be capable of sending samples and test orders to instrument data systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>26.3<\/b> The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-12-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 2.0<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>26.4<\/b> The system should be capable of generically parsing instrument data to extract important sample details and results.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"27._Systems_integration\">27. Systems integration<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.1<\/b> The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.2<\/b> The system should accurately communicate overall system status changes to external systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.3<\/b> The system shall provide a means to choose\u2014based on date and type of data\u2014electronic data and metadata to archive.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.51\" target=\"_blank\">21 CFR Part 58.51<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.4<\/b> The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.5<\/b> The system should feature a reliable, effective, and supported data storage system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.6<\/b> The system should be able to interface directly with a third-party reporting tool.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.7<\/b> The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.8<\/b> The system should provide the ability to modify the data structures of the data storage mechanism as needed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.9<\/b> The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.10<\/b> The system shall provide data storage tools capable of fine-tuning the performance and security of data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-9 and CP-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.11<\/b> The system\u2019s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure and encrypted from manipulation and loss.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.12<\/b> The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.13<\/b> The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.14<\/b> The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>27.15<\/b> The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-16<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.16<\/b> The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-17<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.17<\/b> The system should be able to interface with an external enterprise resource planning system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-13-18<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>27.18<\/b> The system should be capable of interfacing with enterprise middleware.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"28._Laboratory_scheduling_and_capacity_planning\">28. Laboratory scheduling and capacity planning<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25 (c)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.1<\/b> The system should be able to accurately gauge and report test-based work capacity or throughput.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.2<\/b> The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-14-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.3<\/b> The system should provide a means for tasks to be scheduled and allocated against available resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>28.4<\/b> The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"29._Lean_laboratory_and_continuous_improvement\">29. Lean laboratory and continuous improvement<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.1<\/b> The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.2<\/b> The system should provide a means to quickly visualize and assess workflow processes at strategic points.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.42\" target=\"_blank\">21 CFR Part 211.42 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-15-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>29.3<\/b> The system should provide a means for mapping everyday workflow while identifying potential failure points.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"30._Artificial_intelligence_and_smart_systems\">30. Artificial intelligence and smart systems<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.1<\/b> The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.2<\/b> The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.3<\/b> The system should support voice data capture and retrieval as smart laboratory assistance functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.4<\/b> The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-6(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.5<\/b> The system should support predictive maintenance routines for laboratory instruments and equipment.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.6<\/b> The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.7<\/b> The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4(5) and SI-4(7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.8<\/b> The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.28\" target=\"_blank\">21 CFR Part 211.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.46\" target=\"_blank\">21 CFR Part 211.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.69\" target=\"_blank\">21 CFR Part 312.69<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.9.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 18.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PE-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>30.9<\/b> The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-10<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>30.10<\/b> The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1278\" target=\"_blank\">42 CFR Part 493.1278<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-16-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.4 and 5.3.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>30.11<\/b> The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<\/div>\n<!-- \nNewPP limit report\nCached time: 20230516220919\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.056 seconds\nReal time usage: 0.084 seconds\nPreprocessor visited node count: 215\/1000000\nPost\u2010expand include size: 64151\/2097152 bytes\nTemplate argument size: 24\/2097152 bytes\nHighest expansion depth: 7\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 53.463 1 -total\n 81.75% 43.708 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Technology_and_performance_improvements\n 17.89% 9.563 1 Template:Reflist\n 13.65% 7.299 1 Template:LIMSpec\/Laboratory_scheduling_and_capacity_planning\n 12.95% 6.922 1 Template:LIMSpec\/Lean_laboratory_and_continuous_improvement\n 12.03% 6.432 1 Template:LIMSpec\/Artificial_intelligence_and_smart_systems\n 11.24% 6.009 1 Template:LIMSpec\/Instrument_data_systems_functions\n 8.73% 4.666 1 Template:LIMSpec\/Systems_integration\n 8.21% 4.391 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14195-0!canonical and timestamp 20230516220920 and revision id 52020. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Technology_and_performance_improvements\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Technology_and_performance_improvements<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","cf69a4c8871d66429a02b00b9913e6f6_images":[],"cf69a4c8871d66429a02b00b9913e6f6_timestamp":1684275145,"037082b7afd4f3dd9310610fbd0efc7c_type":"article","037082b7afd4f3dd9310610fbd0efc7c_title":"A4. Specialty laboratory functions","037082b7afd4f3dd9310610fbd0efc7c_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Specialty_laboratory_functions","037082b7afd4f3dd9310610fbd0efc7c_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Specialty laboratory functionsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n\r\n\n\nA4. Specialty laboratory functions \nNote: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and forensic science. You'll likely notice that most of the content here isn't covered by ASTM E1578-18.\n\n17. Production management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 211.103\r\n21 CFR Part 226.40 (d)\r\nWHO Technical Report Series, #986, Annex 2, 16.4 and 16.20\n\n17.1 The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n\n\n21 CFR Part 211.103\n\n17.2 The system should provide a means for verification and approval of yield calculations before release for reporting.\n\n\n\n21 CFR Part 820.20\r\n\n21 CFR Part 820.40\r\n\n21 CFR Part 820.186\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11\r\n\nWHO Technical Report Series, #986, Annex 2, 1.0\n\n\n17.3 The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n\n\n21 CFR Part 820.30\r\n21 CFR Part 820.120 (e)\n\n17.4 The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n\n\n21 CFR Part 820.181\r\n21 CFR Part 820.184\n\n17.5 The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 111.255\u2013260\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.105 (b)\r\n\n21 CFR Part 211.130 (e)\r\n\n21 CFR Part 211.134 (c)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.20 (d)\r\n\n21 CFR Part 211.50 (c)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.70 (a)\r\n\n21 CFR Part 820.80 (c)\r\n\n21 CFR Part 820.120 (d)\r\n\nBRC GSFS, Issue 8, 6.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 8.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nFDA Hazard Analysis Critical Control Point Principle 2 and 4\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.25\u201330\n\n\n17.6 The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.205\u2013210\r\n\n21 CFR Part 114.100 (b)\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nBRC GSFS, Issue 8, 3.6.2\r\n\nBRC GSFS, Issue 8, 9.2.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.1.2\r\n\nFDA Hazard Analysis Critical Control Point Principle 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11\r\n\nIFS Food 7, Part 2, 4.2.1.1\r\n\nIFS PACsecure 2, Part 2, 4.2.1.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 15.22\u201323\n\n\n17.7 The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n\n\n\n21 CFR Part 106.100 (e)\r\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.186\r\n\n21 CFR Part 212.50 (b)\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nBRC GSFS, Issue 8, 9.2.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\u20134\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.8 The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 111.123 (a)\r\n\n21 CFR Part 114.100 (c)\r\n\n21 CFR Part 117.150 (d)\r\n\n21 CFR Part 211.22\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 820.70 (b)\r\n\n21 CFR Part 820.75\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 10.3\r\n\nIFS Food 7, Part 2, 4.2.1.2\r\n\nIFS Food 7, Part 2, 4.3.x\r\n\nIFS Food 7, Part 2, 5.11\r\n\nIFS PACsecure 2, Part 2, 4.2.1.2\r\n\nIFS PACsecure 2, Part 2, 4.3.x\r\n\nIFS PACsecure 2, Part 2, 5.11\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)\r\n\nWHO Technical Report Series, #986, Annex 2, 4.0\n\n\n17.9 The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n\n\n\n21 CFR Part 211.110\r\n\n21 CFR Part 212.50\r\n\n21 CFR Part 820.80 (c)\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\r\n\nISO\/TS 22002-1:2009, 14.3\n\n\n17.10 The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n\n\n21 CFR Part 211.111\n\n17.11 The system shall provide a means to track the amount of time between production processes.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.80\r\n\n21 CFR Part 106.100 (f-6)\r\n\n21 CFR Part 117.420\r\n\n21 CFR Part 211.122 (c)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 212.20 (b)\r\n\n21 CFR Part 212.40 (c) and (e)\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.40 (b)\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 820.60\r\n\n21 CFR Part 820.80 (b)\r\n\n21 CFR Part 820.120 (b)\r\n\nBRC GSFS, Issue 8, 3.6.1\r\n\nBRC GSFS, Issue 8, 3.9.2\r\n\nBRC GSFS, Issue 8, 5.4.4\r\n\nBRC GSFS, Issue 8, 3.5.1\r\n\nBRC GSFS, Issue 8, 9.5.1\u20132\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nIFS Food 7, Part 2, 4.5.2\r\n\nIFS Food 7, Part 2, 4.18.1\r\n\nIFS PACsecure 2, Part 2, 4.5.2\r\n\nIFS PACsecure 2, Part 2, 4.18.1\r\n\nISO\/TS 22002-1:2009, 9.3\r\n\nISO\/TS 22002-1:2009, 14.2\r\n\nISO\/TS 22002-4:2013, 4.6.3\r\n\nISO\/TS 22002-4:2013, 4.11.2\r\n\nISO\/TS 22002-6:2016, 4.6.3\r\n\nISO\/TS 22002-6:2016, 4.11.2\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21\r\n\nWHO Technical Report Series, #986, Annex 2, 15.32\u201333\n\n\n17.12 The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n\n\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\nBRC GSFS, Issue 8, 3.5.3\r\n\nBRC GSFS, Issue 8, 9.5.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17\r\n\nWHO Technical Report Series, #986, Annex 2, 14.7 and 14.22\r\n\nWHO Technical Report Series, #986, Annex 2, 16.35\n\n\n17.13 The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n\n\n\n21 CFR Part 106.6\r\n\n21 CFR Part 106.70\r\n\n21 CFR Part 111.113\r\n\n21 CFR Part 111.123 (b)\r\n\n21 CFR Part 114.100 (d)\r\n\n21 CFR Part 120.10\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 211.122 (e)\r\n\n21 CFR Part 211.125 (d)\r\n\n21 CFR Part 211.184\r\n\n21 CFR Part 225.42\r\n\n21 CFR Part 226.42\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.80 (d\u2013e)\r\n\n21 CFR Part 820.90\r\n\n21 CFR Part 820.160\r\n\nBRC GSFS, Issue 8, 3.8.1\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.2\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nIFS Food 7, Part 2, 5.7.1\r\n\nIFS Food 7, Part 2, 5.10\r\n\nIFS PACsecure 2, Part 2, 5.7.1\r\n\nIFS PACsecure 2, Part 2, 5.10\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (g)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28\r\n\nWHO Technical Report Series, #986, Annex 2, 15.44\u201345\r\n\nWHO Technical Report Series, #986, Annex 2, 16.36\r\n\nWHO Technical Report Series, #986, Annex 2, 17.18\u201319\n\n\n17.14 The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n\n\n\n21 CFR Part 7 Subpart C\r\n\n21 CFR Part 117.139\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 507.38\r\n\n21 CFR Part 810 Subpart B\r\n\nBRC GSFS, Issue 8, 3.11.2\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.5\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nIFS Food 7, Part 2, 5.9.2\r\n\nIFS PACsecure 2, Part 2, 5.9.2\r\n\nISO\/TS 22002-1:2009, 15.x\r\n\nISO\/TS 22002-4:2013, 4.12\r\n\nISO\/TS 22002-6:2016, 4.12\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3\r\n\nWHO Technical Report Series, #986, Annex 2, 6.0\r\n\nWHO Technical Report Series, #986, Annex 2, 14.32\n\n\n17.15 The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n\n\n\n21 CFR Part 111.520\r\n\n21 CFR Part 211.165 (f)\r\n\n21 CFR Part 211.204\r\n\n21 CFR Part 212.71 (d)\r\n\n21 CFR Part 820.90 (b-2)\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 7\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6\r\n\nWHO Technical Report Series, #986, Annex 2, 14.29\u201330\n\n\n17.16 The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n\n\n\n21 CFR Part 112.145\r\n\nBRC GSFS, Issue 8, 4.11.8.x\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2\r\n\nISO\/TS 22002-1:2009, 11.5\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8\n\n\n17.17 The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n\n\n\n\r\n\n\n18. Statistical trending and control charts \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\r\n\nISO\/IEC 17025:2017 7.7.1\n\n\n18.1 The system should allow authorized users to configure the generation of statistical trending and control charts.\n\n\n\n21 CFR Part 820.250\r\n\nAIHA-LAP Policies 2018 2A.7.7.1.3\r\n\nASTM E1578-18 E-10-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7.2.8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.8\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 9\r\n\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.2 The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n\n\n\n\r\n\n\n19. Agriculture and food data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nFDA Office of Regulatory Affairs Data Exchange (ORA DX) Program\n\n19.1 The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nUSDA Sampling Procedures for PDP 5.3\r\nUSDA Sampling Procedures for PDP 6.2\n\n19.2 The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n\n\nUSDA Sampling Procedures for PDP 5.4\n\n19.3 The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n\n\nUSDA Sampling Procedures for PDP 5.4.12 and 5.4.14\n\n19.4 The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n\n\n\n21 CFR Part 117.130\u2013135\r\n\n21 CFR Part 120 (throughout)\r\n\n21 CFR Part 123.6\r\n\n21 CFR Part 507, Subpart C\r\n\n61 FR 38806, 9 CFR Part 417.x\r\n\nBRC GSFS, Issue 8, 2.x\r\n\nCodex Alimentarius CXC 1-1969, Ch.2, 3.x\r\n\nE.U. Commission Reg. No. 852\/2004 Article 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X\r\n\nIFS Food 7, Part 2, 2.2.x\r\n\nIFS PACsecure 2, Part 2, 2.2.x\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3\n\n\n19.5 The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n\n\n61 FR 38806, 9 CFR Part 417.4\n\n19.6 The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n\n\n\n21 CFR Part 106.90\r\n\n21 CFR Part 106.92\r\n\n21 CFR Part 106.94\r\n\n21 CFR Part 106.100 (j)\r\n\nBRC GSFS, Issue 8, 3.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20\r\n\nIFS Food 7, Part 2, 5.1\r\n\nIFS PACsecure 2, Part 2, 5.1\r\n\nISO\/IEC 17025:2017 8.8.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4\n\n\n19.7 The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n\n\n\n\r\n\n\n20. Environmental data management \nNot relevant to food and beverage labs.\n\r\n\n\n21. Forensic case and data management \nNot relevant to food and beverage labs.\n\r\n\n\n22. Clinical and public health data management \nNot relevant to food and beverage labs.\n\r\n\n\n23. Veterinary data management \nNot relevant to food and beverage labs.\n\r\n\n\n24. Scientific data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.1 The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n\n\nASTM E1578-18 E-11-2\n\n24.2 The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n\n\n\nASTM E1578-18 E-11-1\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.3 The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n\n\nASTM E1578-18 E-11-4\n\n24.4 The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n\n\n\nAAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3\r\n\nASTM E1578-18 E-11-5\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\n\n\n24.5 The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n\n\nASTM E1578-18 E-11-6\n\n24.6 The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n\n\nASTM E1578-18 E-11-7\n\n24.7 The SDMS shall provide security and access controls for protecting stored data.\n\n\nASTM E1578-18 E-11-8\n\n24.8 The SDMS shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 164.308\r\nASTM E1578-18 E-11-9\n\n24.9 The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n\n\n\n\r\n\n\n25. Health information technology \nNot relevant to food and beverage labs.\n\nReferences \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Specialty_laboratory_functions\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Specialty_laboratory_functions<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:08.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed once.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","037082b7afd4f3dd9310610fbd0efc7c_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Specialty_laboratory_functions rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Specialty_laboratory_functions skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Specialty laboratory functions<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<p><br \/>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"A4._Specialty_laboratory_functions\">A4. Specialty laboratory functions<\/span><\/h2>\n<p><b>Note: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Forensic_science\" title=\"Forensic science\" class=\"wiki-link\" data-key=\"415d36a7b65494677b6d2873d5febec1\">forensic science<\/a>. You'll likely notice that most of the content here isn't covered by <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a>.<\/b>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"17._Production_management\">17. Production management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.1<\/b> The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.103\" target=\"_blank\">21 CFR Part 211.103<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.2<\/b> The system should provide a means for verification and approval of yield calculations before release for reporting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.20\" target=\"_blank\">21 CFR Part 820.20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.186\" target=\"_blank\">21 CFR Part 820.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 1.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.3<\/b> The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003\/94\/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.30\" target=\"_blank\">21 CFR Part 820.30<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (e)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.4<\/b> The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.181\" target=\"_blank\">21 CFR Part 820.181<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.184\" target=\"_blank\">21 CFR Part 820.184<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.5<\/b> The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.255\u2013260<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.130\" target=\"_blank\">21 CFR Part 211.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.134\" target=\"_blank\">21 CFR Part 211.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.20\" target=\"_blank\">21 CFR Part 211.20 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.50\" target=\"_blank\">21 CFR Part 211.50 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 2 and 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f\u2013g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.25\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.6<\/b> The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and\/or supervising operational steps; and the results of any pre-process or post-production inspections.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.205\u2013210<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.22\u201323<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.7<\/b> The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.186\" target=\"_blank\">21 CFR Part 211.186<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.8<\/b> The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.150 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.22\" target=\"_blank\">21 CFR Part 211.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.75\" target=\"_blank\">21 CFR Part 820.75<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (a\u2013b, f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.9<\/b> The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.10<\/b> The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>17.11<\/b> The system shall provide a means to track the amount of time between production processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (f-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c) and (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.60\" target=\"_blank\">21 CFR Part 820.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.120\" target=\"_blank\">21 CFR Part 820.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 14.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.32\u201333<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.12<\/b> The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.35<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.13<\/b> The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.113<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.123 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.122\" target=\"_blank\">21 CFR Part 211.122 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.125\" target=\"_blank\">21 CFR Part 211.125 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.184\" target=\"_blank\">21 CFR Part 211.184<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.80\" target=\"_blank\">21 CFR Part 820.80 (d\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.160\" target=\"_blank\">21 CFR Part 820.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.44\u201345<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.36<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.18\u201319<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.14<\/b> The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\/subpart-C\" target=\"_blank\">21 CFR Part 7 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.38<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\/subpart-B\" target=\"_blank\">21 CFR Part 810 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 15.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 5, 82\u201384<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 6.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.32<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.15<\/b> The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.520<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.165\" target=\"_blank\">21 CFR Part 211.165 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.204\" target=\"_blank\">21 CFR Part 211.204<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.71\" target=\"_blank\">21 CFR Part 212.71 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.90\" target=\"_blank\">21 CFR Part 820.90 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.29\u201330<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.16<\/b> The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.145<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 4.11.8.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>17.17<\/b> The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"18._Statistical_trending_and_control_charts\">18. Statistical trending and control charts<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.1<\/b> The system should allow authorized users to configure the generation of statistical trending and control charts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-10-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>18.2<\/b> The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"19._Agriculture_and_food_data_management\">19. Agriculture and food data management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/orapartners.fda.gov\/cs\/groups\/public\/documents\/document\/b2hh\/bmri\/~edisp\/rpohandbook.pdf\" target=\"_blank\">FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.1<\/b> The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.2<\/b> The system shall allow for the assignment of the \"regulatory sample collection\" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.3<\/b> The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.4.12 and 5.4.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.4<\/b> The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.130\u2013135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507, Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.2, 3.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.5<\/b> The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>19.6<\/b> The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.92<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.8.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>19.7<\/b> The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"20._Environmental_data_management\">20. Environmental data management<\/span><\/h3>\n<p>Not relevant to food and beverage labs.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"21._Forensic_case_and_data_management\">21. Forensic case and data management<\/span><\/h3>\n<p>Not relevant to food and beverage labs.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"22._Clinical_and_public_health_data_management\">22. Clinical and public health data management<\/span><\/h3>\n<p>Not relevant to food and beverage labs.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"23._Veterinary_data_management\">23. Veterinary data management<\/span><\/h3>\n<p>Not relevant to food and beverage labs.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"24._Scientific_data_management\">24. Scientific data management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.1<\/b> The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP\/IP communication.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.2<\/b> The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.3<\/b> The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.4<\/b> The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>24.5<\/b> The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.6<\/b> The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.7<\/b> The SDMS shall provide security and access controls for protecting stored data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.8<\/b> The SDMS shall record an audit trail for each and every record created and modified, using version control.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-11-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>24.9<\/b> The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"25._Health_information_technology\">25. Health information technology<\/span><\/h3>\n<p>Not relevant to food and beverage labs.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<\/div>\n<!-- \nNewPP limit report\nCached time: 20230516220857\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.064 seconds\nReal time usage: 0.079 seconds\nPreprocessor visited node count: 342\/1000000\nPost\u2010expand include size: 100154\/2097152 bytes\nTemplate argument size: 24\/2097152 bytes\nHighest expansion depth: 7\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 33.702 1 -total\n 78.82% 26.564 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Specialty_laboratory_functions\n 20.79% 7.007 1 Template:Reflist\n 17.60% 5.932 1 Template:LIMSpec\/Scientific_data_management\n 15.00% 5.056 1 Template:LIMSpec\/Production_management\n 12.03% 4.054 1 Template:LIMSpec\/Statistical_trending_and_control_charts\n 11.58% 3.902 1 Template:LIMSpec\/Agriculture_and_food_data_management\n 8.64% 2.913 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14194-0!canonical and timestamp 20230516220859 and revision id 52019. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Specialty_laboratory_functions\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Specialty_laboratory_functions<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","037082b7afd4f3dd9310610fbd0efc7c_images":[],"037082b7afd4f3dd9310610fbd0efc7c_timestamp":1684275145,"ad52877e7e3ec7923c1362f4a06f6257_type":"article","ad52877e7e3ec7923c1362f4a06f6257_title":"A3. Maintaining laboratory workflow and operations","ad52877e7e3ec7923c1362f4a06f6257_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Maintaining_laboratory_workflow_and_operations","ad52877e7e3ec7923c1362f4a06f6257_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Maintaining laboratory workflow and operationsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n\r\n\n\nA3. Maintaining laboratory workflow and operations \nNote: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.\n\n7. Document and records management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n10 CFR Part 20 (throughout)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (throughout)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (throughout)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.213\u201314\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 4.3\r\n\nA2LA C223 4.13\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nABFT Accreditation Manual (throughout)\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-1\r\n\nBRC GSFS, Issue 8, 3.1.1\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 5.3\r\n\nISO\/IEC 17025:2017 5.5\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(e) and (h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n\n\n\n7 CFR Part 331 (throughout)\r\n\n9 CFR Part 121 (throughout)\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 7 (throughout)\r\n\n21 CFR Part 58 (throughout)\r\n\n21 CFR Part 117 (throughout)\r\n\n21 CFR Part 211 (throughout)\r\n\n21 CFR Part 212 (throughout)\r\n\n21 CFR Part 225 (throughout)\r\n\n21 CFR Part 226 (throughout)\r\n\n21 CFR Part 312 (throughout)\r\n\n21 CFR Part 606 (throughout)\r\n\n21 CFR Part 810 (throughout)\r\n\n21 CFR Part 812 (throughout)\r\n\n21 CFR Part 820 (throughout)\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (throughout)\r\n\n29 CFR Part 1910.1200 (e)\r\n\n29 CFR Part 1910.1450 (throughout)\r\n\n40 CFR Part 262.214\r\n\n42 CFR Part 73 (throughout)\r\n\n42 CFR Part 93.300\u20135\r\n\n42 CFR Part 493.1200\r\n\n42 CFR Part 493.1232\r\n\n42 CFR Part 493.1239\r\n\n42 CFR Part 493.1251\r\n\n42 CFR Part 493.1291 (j)\r\n\n42 CFR Part 493.1773 (c\u2013d)\r\n\n45 CFR Part 160.310\r\n\n45 CFR Part 164 (throughout)\r\n\n61 FR 38806 (throughout)\r\n\nA2LA C211 (throughout)\r\n\nA2LA C223 (throughout)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (throughout)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories (throughout)\r\n\nAIHA-LAP Policies 2022 Appendix H5.8\r\n\nASTM E1188-11 3.5.2\r\n\nASTM E1492-11 4.3.3.3 and 4.4.4\r\n\nASTM E1578-18 D-1-2\r\n\nBRC GSFS, Issue 8, 3.1.2\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nBRC GSFS, Issue 8, 5.6.2.2\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual (throughout)\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)\r\n\nCJIS Security Policy (throughout)\r\n\nCLSI QMS22 (throughout)\r\n\nEPA 815-R-05-004 (throughout)\r\n\nEPA ERLN Laboratory Requirements (throughout)\r\n\nEPA QA\/G-5 (throughout)\r\n\nE.U. Commission Directive 2003\/94\/EC (throughout)\r\n\nFDA Hazard Analysis Critical Control Point (throughout)\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)\r\n\nIFS Food 7, Part 2 (throughout)\r\n\nIFS PACsecure 2, Part 2 (throughout)\r\n\nISO 15189:2012 (throughout)\r\n\nISO\/IEC 17025:2017 (throughout)\r\n\nISO\/TS 22002-1:2009 (throughout)\r\n\nISO\/TS 22002-4:2013 (throughout)\r\n\nISO\/TS 22002-6:2016 (throughout)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5 (throughout)\r\n\nOECD GLP Principles 8\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3)\r\n\nOSHA 1910.1450(h)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 (throughout)\r\n\nSQF FSC 9, Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B (throughout)\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B (throughout)\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nUSDA Data and Instrumentation for PDP (throughout)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3\r\n\nUSDA Sample Processing and Analysis Procedures for PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\r\n\nWHO Technical Report Series, #961, Annex 13 (throughout)\r\n\nWHO Technical Report Series, #986, Annex 2 (throughout)\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n7.2 The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n\n\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 820.40 (a)\r\n\n42 CFR Part 493.1251 (e)\r\n\nA2LA C211 4.3\r\n\nAAVLD Requirements for an AVMDL Sec. 4.3\r\n\nASTM E1578-18 D-1-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nEPA 815-R-05-004 Chap. III, Sec. 11\r\n\nEPA ERLN Laboratory Requirements 4.2.4.2\r\n\nEPA QA\/G-5 2.1.9\r\n\nISO 15189:2012 4.3\r\n\nISO 15189:2012 5.5.3\r\n\nISO 15189:2012 5.9.3\r\n\nISO\/IEC 17025:2017 7.5.2\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nUSDA Administrative Procedures for the PDP 5.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.5\n\n\n7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.\n\n\nASTM E1578-18 D-1-4\n\n7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 1.1152 (e)\r\n\n21 CFR Part 106.91 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.160\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.60 (c)\r\n\n21 CFR Part 226.58 (e)\r\n\n21 CFR Part 820.250 (b)\r\n\n42 CFR Part 493.43 (c)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 D-1-5\r\n\nBRC GSFS, Issue 8, 5.6.1.1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.3\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 5\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nIFS Food 7, Part 2, 5.5.2\r\n\nIFS Food 7, Part 2, 5.6.2\r\n\nIFS PACsecure 2, Part 2, 5.5.2\r\n\nIFS PACsecure 2, Part 2, 5.6.2\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/IEC 17025:2017 7.2.1.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1\r\n\nWHO Technical Report Series, #986, Annex 2, 15.14\n\n\n7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1151\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.320\r\n\n21 CFR Part 212.20 (c)\r\n\n21 CFR Part 212.70 (b)\r\n\nA2LA C211 5.4.5\r\n\nA2LA C223 5.4\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.4\r\n\nABFT Accreditation Manual Sec. G-12, -14, and -15\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\nCodex Alimentarius CXS 193-1995, Ch.1, 1.3.3\r\n\nCodex Alimentarius CXS 234-1999 (throughout)\r\n\nEPA QA\/G-5 2.2.4\r\n\nE.U. Commission Reg. No. 2073\/2005 Article 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nISO\/IEC 17025:2017 7.2.2.4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nUSDA Administrative Procedures for the PDP 8.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6\r\n\nWHO Technical Report Series, #961, Annex 13, 10.1\r\n\nWHO Technical Report Series, #986, Annex 2, 4.11\r\n\nWHO Technical Report Series, #986, Annex 2, 15.13\n\n\n7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n\n\n\n7 CFR Part 331.10\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 2.32\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n10 CFR Part 30.34 (j-3)\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.134 (c)\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\n40 CFR Part 262.210\u201312\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n42 CFR Part 493.1251\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C211 5.2\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.4\r\n\nAIHA-LAP Policies 2022 (throughout)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCLSI QMS22 (throughout)\r\n\nE.U. Annex 11-2\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nOECD GLP Principles 1.1.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\n\n\n7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\nASTM E1578-18 D-1-7\n\n7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5\r\nEPA ERLN Laboratory Requirements 4.10.6\n\n7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.\n\n\nAAVLD Requirements for an AVMDL Sec. 4.3.4\r\nISO\/IEC 17025:2017 8.3.2\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to the system.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\n\n\n7.11 The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n\n\n\n8. Resource management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n9 CFR Part 2.32\r\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.120\r\n\n29 CFR Part 1910.134 (m)\r\n\n29 CFR Part 1910.1030 (h-1)\r\n\n29 CFR Part 1910.1450 (j)\r\n\n40 CFR Part 262.207\r\n\nA2LA C211 4.13.2.3\r\n\nA2LA C223 5.2\r\n\nA2LA C223 5.7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nBRC GSFS, Issue 8, 7.3.1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.1\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.1\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-3 and -4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1020 (throughout)\r\n\nOSHA 1910.1200(b)(3) and (h)\r\n\nOSHA 1910.1450 (throughout)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #996, Annex 5, 8.1\n\n\n8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n\n\n\n21 CFR Part 820.198\r\n\n42 CFR Part 493.1233\r\n\nBRC GSFS, Issue 8, 3.10.1\u20132\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21\r\n\nIFS Food 7, Part 2, 5.8\r\n\nIFS PACsecure 2, Part 2, 5.8\r\n\nISO\/IEC 17025:2017 7.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.10\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n\n\n\n5 CFR Part 930.301\r\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.15\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n21 CFR Part 211.25\r\n\n29 CFR Part 1910.1450 (f)\r\n\n42 CFR Part 73.15\r\n\nA2LA C223 5.2\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3\r\n\nASTM E1578-18 E-1-1\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCJIS Security Policy 5.2.1\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Sampling Procedures for PDP 6.1.2\u20133\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.3 The system shall allow training sessions and reviews to be scheduled for personnel.\n\n\n\n5 CFR Part 930.301\r\n\n29 CFR Part 1910.1450 (f)\r\n\nABFT Accreditation Manual Sec. B\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7\r\n\nASTM E1578-18 E-1-2\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.4 The system should provide access to relevant training materials to personnel attending training sessions.\n\n\n\n5 CFR Part 930.301\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 110.10 (c)\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.10\r\n\n29 CFR Part 1910.1450 (f)\r\n\n40 CFR Part 262.207\r\n\nA2LA C223 5.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5\r\n\nASTM E1578-18 E-1-3\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.2.3\r\n\nEPA ERLN Laboratory Requirements 4.2.4.1\r\n\nEPA QA\/G-5 2.1.8\r\n\nE.U. Commission Directive 2003\/94\/EC Article 7.4\r\n\nFDA Hazard Analysis Critical Control Point Guidelines\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\r\n\nISO 15189:2012 5.1.9\r\n\nNIST 800-53, Rev. 5, AT-2\u2013AT-4\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e\r\n\nUSDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3\r\n\nWADA International Standard for Laboratories (ISL) 5.2.2\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (e)\r\n\nWHO Technical Report Series, #986, Annex 2, 9.4\r\n\nWHO Technical Report Series, #986, Annex 2, 10\n\n\n8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n\n\n\nABFT Accreditation Manual Sec. B\r\n\nASTM E1578-18 E-1-4\r\n\nIFS Food 7, Part 2, 3.3\r\n\nIFS PACsecure 2, Part 2, 3.3\n\n\n8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n\n\n\nASTM E1578-18 E-1-5\r\n\nBRC GSFS, Issue 8, 7.1.x\r\n\nNIST 800-53, Rev. 5, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 5, CP-3\r\n\nNIST 800-53, Rev. 5, IR-2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.9\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.9\n\n\n8.7 The system should be able to produce a training matrix of personnel.\n\n\n\n7 CFR Part 331.15\r\n\n9 CFR Part 121.10 \r\n\n9 CFR Part 121.15 \r\n\n21 CFR Part 11.10 (i)\r\n\n21 CFR Part 58.29\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 211.25\r\n\n21 CFR Part 225.10\r\n\n21 CFR Part 226.10\r\n\n21 CFR Part 226.40\r\n\n21 CFR Part 820.25\r\n\n29 CFR Part 1910.1030 (g-2)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n29 CFR Part 1910.1200 (h)\r\n\n29 CFR Part 1910.1450 (e)\r\n\n42 CFR Part 73.10\r\n\n42 CFR Part 73.15\r\n\n42 CFR Part 493.43 (c)\r\n\n42 CFR Part 493.1235\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nA2LA C223 5.2\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.2\r\n\nAAVLD Requirements for an AVMDL Appendix 1\r\n\nABFT Accreditation Manual Sec. B\r\n\nAIHA-LAP Policies 2022 (various parts)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133\r\n\nASTM E1578-18 C-3-5\r\n\nASTM E1578-18 D-1-6\r\n\nASTM E1578-18 E-1-6\r\n\nBRC GSFS, Issue 8, 5.6.2.3\u20134\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nE.U. Annex 11-2\r\n\nEPA 815-R-05-004 Chap. III, Sec. 10 and 17\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 1\r\n\nEPA QA\/G-5 2.1.8\r\n\nISO 15189:2012 4.1.2.1\r\n\nISO 15189:2012 5.1.6\r\n\nISO 15189:2012 5.1.9\r\n\nISO\/IEC 17025:2017 6.2.2\r\n\nISO\/IEC 17025:2017 6.2.3\r\n\nISO\/IEC 17025:2017 6.2.5\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nOECD GLP Principles 1.1.2\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\n\n\n8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n\n\n\n9. Compliance management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17 \r\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1251 (d)\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\nASTM E1578-18 C-4-7\r\n\nASTM E1578-18 E-2-1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-14\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\n\n\n9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-2\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCJIS Security Policy Appendix G.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Annex 11-9\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AC-2(4) and AC-6(9)\r\n\nNIST 800-53, Rev. 5, AU-2 and AU-3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nOECD GLP Principles 8.3.5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5 (throughout)\n\n\n9.2 The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1274\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-3\r\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.3.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12.4\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nNIST 800-53, Rev. 5, AU-3 and AU-8\r\n\nOECD GLP Principles 8.3.5\r\n\nUSDA Data and Instrumentation for PDP 8.1.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 E-2-4\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nNIST 800-53, Rev. 5, AU-3\r\n\nOECD GLP Principles 8.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.4 The system's audit trail shall document the previous and current value of a modified field.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 11.70\r\n\n21 CFR Part 58.130 (e)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1251 (d)\r\n\n45 CFR Part 164.310\r\n\nASTM E1578-18 E-2-5\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nE.U. Annex 11-14\r\n\nNIST 800-53, Rev. 5, AU-10\r\n\nOECD GLP Principles 8.3.5\n\n\n9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n\n\n21 CFR Part 11.70\r\nE.U. Annex 11-14\r\nNIST 800-53, Rev. 5, AU-10\n\n9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.\n\n\n\n21 CFR Part 11.10 (e)\r\n\n21 CFR Part 58.130 (e)\r\n\n42 CFR Part 493.1274 (d)\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-6 and AU-12\r\n\nOECD GLP Principles 8.3.5\n\n\n9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n\n\n\n10. Instrument and equipment management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-3-1\n\n10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.\n\n\nASTM E1578-18 E-3-2\n\n10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.\n\n\nASTM E1578-18 E-3-3\n\n10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n\n\nASTM E1578-18 E-3-4\n\n10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n\n\nASTM E1578-18 E-3-5\n\n10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n\n\nASTM E1578-18 E-3-6\n\n10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 225.30 (b-4)\r\n\n21 CFR Part 606.60\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1252 (b-3)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.2\r\n\nA2LA C223 5.5\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-7\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.6.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nNIST 800-53, Rev. 5, MA-2 and MA-2(2)\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.2\r\n\nUSDA Data and Instrumentation for PDP 6\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 13.5\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n\n\n\n21 CFR Part 225.30 (b-4)\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.9\r\n\nASTM E1578-18 E-3-8\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n\n\n\n21 CFR Part 211.160 (b-4)\r\n\nA2LA C211 5.5.7\r\n\nA2LA C223 5.6\r\n\nABFT Accreditation Manual Sec. E-21\r\n\nASTM E1578-18 E-3-9\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nCLSI QMS22 2.1.2.1\r\n\nIFS Food 7, Part 2, 5.4.3\r\n\nIFS PACsecure 2, Part 2, 5.4.3\r\n\nISO 15189:2012 5.3.1.5\r\n\nISO\/IEC 17025:2017 6.4.4\r\n\nISO\/IEC 17025:2017 6.4.9\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.4\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)\r\n\nWHO Technical Report Series, #986, Annex 2, 13.10\n\n\n10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n\n\n\n21 CFR Part 111.117\r\n\n21 CFR Part 820.72 (b-2)\r\n\nASTM E1578-18 E-3-10\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n\n\n\n21 CFR Part 820.72 (b-1)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.6.2.1\r\n\nA2LA C223 5.6\r\n\nAAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\nAIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2\r\n\nISO\/IEC 17025:2017 6.4.13\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/TS 22002-4:2013, 4.7.1\r\n\nISO\/TS 22002-6:2016, 4.7\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)\r\n\nUSDA Data and Instrumentation for PDP 6.1\n\n\n10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n\n\nASTM E1578-18 E-3-11\n\n10.12 The system shall support the use of predefined intervals when calculating instrument event dates.\n\n\n\n21 CFR Part 110.40 (f)\r\n\n21 CFR Part 211.105 (b)\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 5.5.4 and 5.5.5\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\nASTM E1578-18 E-3-12\r\n\nBRC GSFS, Issue 8, 6.4.x\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1\r\n\nIFS Food 7, Part 2, 5.4.1\r\n\nIFS PACsecure 2, Part 2, 5.4.1\r\n\nISO 15189:2012 5.3.1.7\r\n\nISO\/IEC 17025:2017 6.4.8\r\n\nISO\/IEC 17025:2017 6.4.13\r\n\nNIST 800-53, Rev. 5, CM-8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 7.2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j\r\n\nWADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4\r\n\nWHO Technical Report Series, #961, Annex 13, 6.1\n\n\n10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n\n\nASTM E1578-18 E-3-13\n\n10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n\n\n\n10 CFR Part 20.2103\r\n\n21 CFR Part 58.63\r\n\n21 CFR Part 111.117\r\n\n21 CFR Part 211.67\u201368\r\n\n21 CFR Part 211.160 (b-4)\r\n\n21 CFR Part 211.182\r\n\n21 CFR Part 211.194 (d)\r\n\n21 CFR Part 212.30 (b)\r\n\n21 CFR Part 212.60 (e)\r\n\n21 CFR Part 820.70 (g)\r\n\n21 CFR Part 820.72\r\n\n42 CFR Part 493.1254\r\n\n42 CFR Part 493.1255\r\n\nA2LA C211 4.13.2.1\r\n\nA2LA C211 5.5.2\r\n\nA2LA C211 5.10.4\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5\r\n\nABFT Accreditation Manual Sec. E-20 and -23\r\n\nABFT Accreditation Manual Sec. F-1 and I-1\r\n\nAIHA-LAP Policies 2022 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-14\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA ERLN Laboratory Requirements 4.11.11\u201313\r\n\nEPA QA\/G-5 2.2.6\u20137\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19\r\n\nIFS Food 7, Part 2, 5.4.2\r\n\nIFS PACsecure 2, Part 2, 5.4.2\r\n\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.4\u20135\r\n\nISO\/IEC 17025:2017 6.4.13\r\n\nNIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.1\r\n\nSQF FSC 9, Food Manufacturing, Part B, 11.2.3.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.4\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c\r\n\nWADA International Standard for Laboratories (ISL) 5.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.46\r\n\nWHO Technical Report Series, #986, Annex 2, 16.23\n\n\n10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n\n\n\n11. Batch and lot management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.105 (a)\r\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-1\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA ERLN Laboratory Requirements 4.10.1\r\n\nOECD GLP Principles 6.2\n\n\n11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\nASTM E1578-18 E-4-2\r\n\nEPA ERLN Laboratory Requirements 4.10.1\n\n\n11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n\n\n\n21 CFR Part 211.80\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 820.65\r\n\nASTM E1578-18 E-4-3\n\n\n11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n\n\nASTM E1578-18 E-4-4\n\n11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n\n\nE.U. Annex 11-15\n\n11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n\n\n\n12. Scheduled event management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 129.80 (g)\r\nASTM E1578-18 E-5-1\r\nUSDA Sampling Procedures for PDP 5.6\u20137\n\n12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n\n\n21 CFR Part 212.61 (a)\r\n21 CFR Part 211.166 (b)\r\nASTM E1578-18 E-5-2\n\n12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n\n\nASTM E1578-18 E-5-3\n\n12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n\n\nASTM E1578-18 E-5-4\n\n12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n\n\nASTM E1578-18 E-5-5\n\n12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n\n\n\n13. Instrument data capture and control \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-6-1\n\n13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n\n\nASTM E1578-18 E-6-2\n\n13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n\n\nASTM E1578-18 E-6-3\n\n13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n\n\nASTM E1578-18 E-6-4\n\n13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n\n\nASTM E1578-18 E-6-5\n\n13.5 The system should be able to accept the results uploaded from an interfaced instrument.\n\n\nASTM E1578-18 E-6-6\n\n13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n\n\nASTM E1578-18 E-6-7\n\n13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n\n\nASTM E1578-18 E-6-8\n\n13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n\n\n\n14. Standard and reagent management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 58.83\r\n\n29 CFR Part 1910.1200 (g)\r\n\n29 CFR Part 1910.1450 (h)\r\n\n42 CFR Part 493.1252 (c)\r\n\nABFT Accreditation Manual Sec. E-17\r\n\nASTM E1578-18 E-7-1\r\n\nISO 15189:2012 5.3.2.4\u20135\r\n\nOECD GLP Principles 4.4\n\n\n14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n\n\n\n7 CFR Part 331.3\r\n\n9 CFR Part 121.3\r\n\n21 CFR Part 312.58 (b)\r\n\n42 CFR Part 73.3\u20134 (c)\r\n\nASTM E1578-18 E-7-2\r\n\nEPA ERLN Laboratory Requirements 4.1.12\r\n\nISO 15189:2012 5.3.2.4\r\n\nWHO Technical Report Series, #986, Annex 2, 12.20\n\n\n14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n\n\nASTM E1578-18 E-7-3\r\nISO 15189:2012 5.3.2.4\n\n14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n\n\nASTM E1578-18 E-7-4\r\nISO 15189:2012 5.3.2.4\n\n14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n\n\nASTM E1578-18 E-7-5\r\nISO 15189:2012 5.3.2.4\n\n14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n\n\n\n15. Inventory management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-8-1\r\nCAP Laboratory Accreditation Manual\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n\n\n\n21 CFR Part 212.60 (d)\r\n\nASTM E1578-18 E-8-2\r\n\nCLSI QMS22 2.1.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n\n\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 212.60 (d)\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e-6)\r\n\n29 CFR Part 1910.1200 (f-6) and (f-10)\r\n\n40 CFR Part 262.206\r\n\nASTM E1578-18 E-8-3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOSHA 1910.1200(b)(3) and (f)\r\n\nOSHA 1910.1450(h)\r\n\nWHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41\r\n\nWHO Technical Report Series, #986, Annex 2, 15.10\u201312\n\n\n15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n\n\n\n21 CFR Part 117.420\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 820.50\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-4\r\n\nBRC GSFS, Issue 8, 3.5.1.4\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.2.8\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5\r\n\nIFS Food 7, Part 2, 4.4.1\r\n\nIFS PACsecure 2, Part 2, 4.4.1\r\n\nISO\/TS 22002-1:2009, 9.2\r\n\nISO\/TS 22002-4:2013, 4.6.2\r\n\nISO\/TS 22002-6:2016, 4.6.2\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)\r\n\nUSDA Administrative Procedures for the PDP 7.1\r\n\nWHO Technical Report Series, #961, Annex 13, 7.1 and 7.3\r\n\nWHO Technical Report Series, #986, Annex 2, 14.8\n\n\n15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n\n\n\n21 CFR Part 211.196\r\n\n21 CFR Part 212.90\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 606.165\r\n\n29 CFR Part 1910.1450 Appendix A (I)\r\n\nA2LA C211 4.6\r\n\nASTM E1578-18 E-8-5\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5\n\n\n15.5 The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n\n\n\n21 CFR Part 211.82 (b)\r\n\n21 CFR Part 211.84 (a)\r\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n21 CFR Part 211.142 (a)\r\n\n21 CFR Part 212.40 (c)\r\n\nASTM E1578-18 E-8-6\r\n\nWHO Technical Report Series, #986, Annex 2, 12.18\n\n\n15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n\n\n\n21 CFR Part 211.89\r\n\n21 CFR Part 211.110 (d)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 E-8-7\n\n\n15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.\n\n\n\n21 CFR Part 211.89\r\nASTM E1578-18 E-8-8\n\n\n15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.\n\n\n\n16. Investigation and quality management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n21 CFR Part 312.62 (b)\r\n21 CFR Part 812.140 (a-3)\n\n16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n\n\n\n21 CFR Part 312.57 (a)\r\n\n21 CFR Part 312.62 (a)\r\n\n21 CFR Part 606.165\r\n\n21 CFR Part 812.140 (a-2) and (b-2)\n\n\n16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 58.81 (a)\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.111\r\n\n21 CFR Part 211.192\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 606.171\r\n\n42 CFR Part 493.1253 (b-2)\r\n\nA2LA C211 5.4\r\n\nABFT Accreditation Manual C-16\r\n\nABFT Accreditation Manual F-2\r\n\nABFT Accreditation Manual J-3\r\n\nASTM E1578-18 E-9-1\r\n\nBRC GSFS, Issue 8, 5.6.2.3\r\n\nBRC GSFS, Issue 8, 9.3.4\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA QA\/G-5 2.2.4\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1\r\n\nISO\/IEC 17025:2017 7.2.1.7\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nISO\/IEC 17025:2017 7.10.2\r\n\nISO\/IEC 17025:2017 8.7\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 7.3\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)\r\n\nUSDA Administrative Procedures for the PDP 8.2.2\r\n\nWADA International Standard for Laboratories (ISL) 5.3.6\r\n\nWHO Technical Report Series, #986, Annex 2, 16.3\n\n\n16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n\n\n42 CFR Part 493.1282\r\nASTM E1578-18 E-9-2\r\nE.U. Commission Reg. No. 2073\/2005 Article 9\n\n16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n\n\n\n21 CFR Part 606.100 (c)\r\n\n42 CFR Part 493.1282\r\n\nASTM E1578-18 E-9-3\r\n\nCLSI QMS22 2.1.2.1\r\n\nCLSI QMS22 2.2.2.3\r\n\nEPA QA\/G-5 2.2.10\r\n\nWHO Technical Report Series, #986, Annex 2, 17.12\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n\n\n\n10 CFR Part 30.34 (g)\r\n\n21 CFR Part 112.147\r\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 606.100 (c)\r\n\n21 CFR Part 820.100\r\n\n42 CFR Part 493.1282\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.9 and 4.11\r\n\nASTM E1578-18 E-9-4\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.6.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, IR-5\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.9\r\n\nWHO Technical Report Series, #961, Annex 13, 11.1\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\r\n\nWHO Technical Report Series, #996, Annex 5, 11.12\n\n\n16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n\n\n\n21 CFR Part 225.58 (d)\r\n\n21 CFR Part 225.158\r\n\n42 CFR Part 493.1282\r\n\n42 CFR Part 493.1289\r\n\n61 FR 38806, 9 CFR Part 417.3\r\n\nA2LA C211 4.8 and 4.11\r\n\nASTM E1578-18 E-9-5\r\n\nBRC GSFS, Issue 8, 3.4.3\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy Appendix G.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nNIST 800-53, Rev. 5, AU-6(1)\r\n\nNIST 800-53, Rev. 5, IR-4(1) and IR-5\r\n\nNIST 800-53, Rev. 5, SI-2 and SI-4\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3\r\n\nWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)\r\n\nWHO Technical Report Series, #986, Annex 2, 5.0\n\n\n16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n\n\nASTM E1578-18 E-9-6\n\n16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n\n\n9 CFR Part 2.35\n\n16.9 The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n\n\n\nReferences \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Maintaining_laboratory_workflow_and_operations\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Maintaining_laboratory_workflow_and_operations<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:08.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed once.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","ad52877e7e3ec7923c1362f4a06f6257_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Maintaining_laboratory_workflow_and_operations rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Maintaining_laboratory_workflow_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Maintaining laboratory workflow and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<p><br \/>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"A3._Maintaining_laboratory_workflow_and_operations\">A3. Maintaining laboratory workflow and operations<\/span><\/h2>\n<p><b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch\/lot management, and instrument management to standard\/reagent management and investigation management.<\/b>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"7._Document_and_records_management\">7. Document and records management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.213\u201314<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(e) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.1<\/b> The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.214\" target=\"_blank\">40 CFR Part 262.214<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.300\" target=\"_blank\">42 CFR Part 93.300\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1200\" target=\"_blank\">42 CFR Part 493.1200<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1239\" target=\"_blank\">42 CFR Part 493.1239<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1773\" target=\"_blank\">42 CFR Part 493.1773 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/160.310\" target=\"_blank\">45 CFR Part 160.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 Appendix H5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.3 and 4.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.2<\/b> The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.40\" target=\"_blank\">21 CFR Part 820.40 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.3<\/b> The system shall be able to clearly provide the most current version of a document and archive prior versions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.4<\/b> The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.91 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.250\" target=\"_blank\">21 CFR Part 820.250 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Methods 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.14<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.5<\/b> The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.320<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.20\" target=\"_blank\">21 CFR Part 212.20 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-12, -14, and -15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995, Ch.1, 1.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 19.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4b<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.13<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.6<\/b> The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.10\" target=\"_blank\">7 CFR Part 331.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (j-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.210\" target=\"_blank\">40 CFR Part 262.210\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>7.7<\/b> The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.8<\/b> The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.9<\/b> The system shall support the addition of accurate cross-references and page numbers to new documents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.3.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.3.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>7.10<\/b> The system shall be capable of uniquely identifying documents created in and added to the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>7.11<\/b> The system shall provide both standard and 'ad hoc' means to query or search for documents, records, and other types of data and information in the system.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"8._Resource_management\">8. Resource management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.32\" target=\"_blank\">9 CFR Part 2.32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134 (m)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories B3\u2013B5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-3 and -4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 8.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.1<\/b> The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.198\" target=\"_blank\">21 CFR Part 820.198<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1233\" target=\"_blank\">42 CFR Part 493.1233<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.10.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.2<\/b> The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.3<\/b> The system shall allow training sessions and reviews to be scheduled for personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.4<\/b> The system should provide access to relevant training materials to personnel attending training sessions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.207\" target=\"_blank\">40 CFR Part 262.207<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 7.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Guidelines<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2\u2013AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.5<\/b> The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 3.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.6<\/b> The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 7.1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.7<\/b> The system should be able to produce a training matrix of personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.15\" target=\"_blank\">7 CFR Part 331.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.10\" target=\"_blank\">9 CFR Part 121.10 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.15\" target=\"_blank\">9 CFR Part 121.15 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.29\" target=\"_blank\">21 CFR Part 58.29<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.25\" target=\"_blank\">21 CFR Part 211.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.10\" target=\"_blank\">21 CFR Part 225.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.10\" target=\"_blank\">21 CFR Part 226.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.40\" target=\"_blank\">21 CFR Part 226.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.25\" target=\"_blank\">21 CFR Part 820.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.10\" target=\"_blank\">42 CFR Part 73.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.15\" target=\"_blank\">42 CFR Part 73.15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1235\" target=\"_blank\">42 CFR Part 493.1235<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Appendix 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 (various parts)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 10 and 17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 1.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 6.1<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>8.8<\/b> The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"9._Compliance_management\">9. Compliance management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.1<\/b> The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-2 and AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5 (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.2<\/b> The system shall document in the audit trail any event\u2014including administrative and privileged functions\u2014that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3 and AU-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.3<\/b> The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.4<\/b> The system's audit trail shall document the previous and current value of a modified field.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1251\" target=\"_blank\">42 CFR Part 493.1251 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.310\" target=\"_blank\">45 CFR Part 164.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-2-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.5<\/b> The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.70\" target=\"_blank\">21 CFR Part 11.70<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>9.6<\/b> The system shall prevent a user from copying and pasting the electronic signature of another user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.130\" target=\"_blank\">21 CFR Part 58.130 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6 and AU-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 8.3.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>9.7<\/b> The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"10._Instrument_and_equipment_management\">10. Instrument and equipment management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.1<\/b> The system should provide a means for tracking usage of laboratory equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.2<\/b> The system shall provide a means for planning the use of and reserving equipment and instruments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.3<\/b> The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.4<\/b> The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.5<\/b> The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.6<\/b> The system shall be able to group instruments together in specific ways, including by type and laboratory location.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.60\" target=\"_blank\">21 CFR Part 606.60<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (b-3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2 and MA-2(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.7<\/b> The system shall allow for the configuration of calibration and maintenance frequency and time frames for\u2014as well as the manual and automatic scheduling of calibration or maintenance of\u2014equipment, instruments, and systems. Available intervals should include days, weeks, months, and years.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.30\" target=\"_blank\">21 CFR Part 225.30 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.8<\/b> The system shall provide clear alerts or notifications when an instrument nears its calibration due date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.9<\/b> The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.10<\/b> The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72 (b-1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.6.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.6.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.11<\/b> The system shall be able to link a calibration activity to certified reference material or designated measurement processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.12<\/b> The system shall support the use of predefined intervals when calculating instrument event dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110.40 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.105\" target=\"_blank\">21 CFR Part 211.105 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.4 and 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 6.4.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.13<\/b> The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information\u2014such as manufacturer, model number, serial number, and calibration and maintenance history\u2014within the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-13<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>10.14<\/b> The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.63\" target=\"_blank\">21 CFR Part 58.63<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.117<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.67\" target=\"_blank\">21 CFR Part 211.67\u201368<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b-4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.182\" target=\"_blank\">21 CFR Part 211.182<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.30\" target=\"_blank\">21 CFR Part 212.30 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.72\" target=\"_blank\">21 CFR Part 820.72<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1254\" target=\"_blank\">42 CFR Part 493.1254<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1255\" target=\"_blank\">42 CFR Part 493.1255<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-20 and -23<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. F-1 and I-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.11\u201313<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.23<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>10.15<\/b> The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"11._Batch_and_lot_management\">11. Batch and lot management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.1<\/b> The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.10.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.2<\/b> The system shall maintain the links between component parts of a batch and track the batch throughout the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.80\" target=\"_blank\">21 CFR Part 211.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.65\" target=\"_blank\">21 CFR Part 820.65<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>11.3<\/b> The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-4-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.4<\/b> The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>11.5<\/b> The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"12._Scheduled_event_management\">12. Scheduled event management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.6\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.1<\/b> The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.2<\/b> The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.3<\/b> The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.4<\/b> The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-5-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>12.5<\/b> The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"13._Instrument_data_capture_and_control\">13. Instrument data capture and control<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.1<\/b> The system shall be able to trigger an instrument event after a definable number of uses of that instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.2<\/b> The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.3<\/b> The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.4<\/b> The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.5<\/b> The system should be able to accept the results uploaded from an interfaced instrument.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.6<\/b> The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.7<\/b> The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP\/IP, and USB.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-6-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>13.8<\/b> The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"14._Standard_and_reagent_management\">14. Standard and reagent management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.83\" target=\"_blank\">21 CFR Part 58.83<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.1<\/b> The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.3\" target=\"_blank\">7 CFR Part 331.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.3\" target=\"_blank\">9 CFR Part 121.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.58\" target=\"_blank\">21 CFR Part 312.58 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.3\" target=\"_blank\">42 CFR Part 73.3\u20134 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.20<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>14.2<\/b> The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and\/or chemical stability.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.3<\/b> The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.4<\/b> The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-7-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>14.5<\/b> The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"15._Inventory_management\">15. Inventory management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>15.1<\/b> The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.2<\/b> The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200 (f-6) and (f-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.206\" target=\"_blank\">40 CFR Part 262.206<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1200\" target=\"_blank\">OSHA 1910.1200(b)(3) and (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.10\u201312<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.3<\/b> The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.420<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.50\" target=\"_blank\">21 CFR Part 820.50<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009, 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016, 4.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 14.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.4<\/b> The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.196\" target=\"_blank\">21 CFR Part 211.196<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.90\" target=\"_blank\">21 CFR Part 212.90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 Appendix A (I)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.5<\/b> The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.82\" target=\"_blank\">21 CFR Part 211.82 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.142\" target=\"_blank\">21 CFR Part 211.142 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 12.18<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.6<\/b> The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 211.110 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.7<\/b> The system should allow authorized personnel to retire faulty or poor quality materials from use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.89\" target=\"_blank\">21 CFR Part 211.89<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-8-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>15.8<\/b> The system shall clearly designate a standard or reagent as being disposed or consumed.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"16._Investigation_and_quality_management\">16. Investigation and quality management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.1<\/b> The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.165\" target=\"_blank\">21 CFR Part 606.165<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (a-2) and (b-2)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.2<\/b> The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.81\" target=\"_blank\">21 CFR Part 58.81 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.111\" target=\"_blank\">21 CFR Part 211.111<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.192\" target=\"_blank\">21 CFR Part 211.192<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.171\" target=\"_blank\">21 CFR Part 606.171<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1253\" target=\"_blank\">42 CFR Part 493.1253 (b-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual C-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual F-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual J-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.1.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.10.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.9 and 5.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 16.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.3<\/b> The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005 Article 9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.4<\/b> The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.5<\/b> The system should trigger an alert or notification when an OOS\/OOT status is found, indicating a delay in processing and prompting a documented investigation to identify the root cause.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.147<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.100\" target=\"_blank\">21 CFR Part 606.100 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.100\" target=\"_blank\">21 CFR Part 820.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.9 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 11.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.6<\/b> The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1282\" target=\"_blank\">42 CFR Part 493.1282<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1289\" target=\"_blank\">42 CFR Part 493.1289<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.8 and 4.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point Principle 5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-4(1) and IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-2 and SI-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 5.0<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>16.7<\/b> The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-9-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.8<\/b> The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization\u2019s standard operating procedures.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>16.9<\/b> The system should provide a means for documenting and maintaining records related to the acquisition, disposition, euthanization, and welfare of animals involved in investigations (research), with the ability to include important metadata such as name and demographics of the acquirer, their USDA license or registration number, the USDA tag\/tattoo number of the animal, the animal's description, etc.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<\/div>\n<!-- \nNewPP limit report\nCached time: 20230516220835\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.197 seconds\nReal time usage: 0.225 seconds\nPreprocessor visited node count: 1055\/1000000\nPost\u2010expand include size: 286007\/2097152 bytes\nTemplate argument size: 24\/2097152 bytes\nHighest expansion depth: 7\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 61.787 1 -total\n 87.61% 54.129 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Maintaining_laboratory_workflow_and_operations\n 11.87% 7.337 1 Template:Reflist\n 8.87% 5.480 1 Template:LIMSpec\/Resource_management\n 8.40% 5.191 1 Template:LIMSpec\/Compliance_management\n 8.17% 5.045 1 Template:LIMSpec\/Document_management\n 7.83% 4.839 1 Template:LIMSpec\/Instrument_and_equipment_management\n 7.13% 4.405 1 Template:LIMSpec\/Investigation_and_quality_management\n 7.00% 4.326 1 Template:LIMSpec\/Inventory_management\n 6.70% 4.141 1 Template:LIMSpec\/Batch_and_lot_management\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14193-0!canonical and timestamp 20230516220836 and revision id 52018. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Maintaining_laboratory_workflow_and_operations\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Maintaining_laboratory_workflow_and_operations<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","ad52877e7e3ec7923c1362f4a06f6257_images":[],"ad52877e7e3ec7923c1362f4a06f6257_timestamp":1684275145,"5fd4fe4c2259365fa0cb3f7c8d94a926_type":"article","5fd4fe4c2259365fa0cb3f7c8d94a926_title":"A2. Primary laboratory workflow","5fd4fe4c2259365fa0cb3f7c8d94a926_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Primary_laboratory_workflow","5fd4fe4c2259365fa0cb3f7c8d94a926_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Primary laboratory workflowFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n\r\n\n\nA2. Primary laboratory workflow \nNote: These categories cover what ASTM E1578-18 considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.\n\n1. Sample and experiment registration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 1.1149\r\n\n42 CFR Part 493.1241\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 C-1-1\n\n\n1.1 The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\n\n\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.101\r\n\n21 CFR Part 226.80\r\n\n21 CFR Part 606.120 (b)\r\n\n21 CFR Part 606.121 (c\u2013i)\r\n\n21 CFR Part 606.140 (c)\r\n\n29 CFR Part 1910.1030 (g)\r\n\n29 CFR Part 1910.1096 (e1-6)\r\n\n42 CFR Part 493.1232\r\n\nABFT Accreditation Manual Sec. D\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1492-11 4.1.1.6\r\n\nASTM E1578-18 C-1-2\r\n\nCLSI QMS22 2.2.1.2\r\n\nEPA ERLN Laboratory Requirements 3.2.2\r\n\nEPA QA\/G-5 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 15\r\nOECD GLP Principles 6.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\nUSDA Sampling Procedures for PDP 6.4.1.2.6\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.2 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.\n\n\n45 CFR Part 162.410\r\nCJIS Security Policy 5.6.1\n\n1.3 The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\n\n\n42 CFR Part 493.1241\r\nASTM E1578-18 C-1-3\n\n1.4 The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\n\n\n\n7 CFR Part 91.19\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n40 CFR Part 262.18\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C2.1\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 C-1-4\r\n\nUSDA Sampling Procedures for PDP 6.4.1.1.3\n\n\n1.5 The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.\n\n\nASTM E1578-18 C-1-5\n\n1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.\n\n\nASTM E1578-18 C-1-6\n\n1.7 The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.\n\n\nASTM E1578-18 C-1-7\n\n1.8 The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.\n\n\n\n7 CFR Part 91.19\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 1.1149\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.170\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 312.57 (d)\r\n\n40 CFR Part 141.33\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1241\r\n\n42 CFR Part 493.1242\r\n\n42 CFR Part 493.1274 (f)\r\n\n42 CFR Part 493.1283\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133\r\n\nAAVLD Requirements for an AVMDL Sec. 5.7.1.2\r\n\nABFT Accreditation Manual Sec. D\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C2\r\n\nASTM E1578-18 C-1-8\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 6 and 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8\r\n\nEPA 815-R-05-004 Supplement 1\r\n\nEPA ERLN Laboratory Requirements 3.2\r\n\nEPA ERLN Laboratory Requirements 4.4.10\u201311\r\n\nEPA ERLN Laboratory Requirements 4.7.1\u20136\r\n\nEPA QA\/G-5 2.2.2 and 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nISO 15189:2012 5.7.2\r\n\nISO\/IEC 17025:2017 7.3.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 6.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13\r\n\nUSDA Sampling Procedures for PDP 5.1\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11 and 17.21\n\n\n1.9 The system shall be able to define the collection and sampling details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), sampling methods used, safety concerns, and retention period.\n\n\n\nASTM E1578-18 C-1-9\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.4\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 3.2.1\r\n\nEPA ERLN Laboratory Requirements 4.4.5\n\n\n1.10 The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\n\n\nASTM E1578-18 C-1-10\n\n1.11 The system should support the creation of user-definable default sample registration preferences and\/or input screens.\n\n\n\n21 CFR Part 1.1149\r\n\nASTM E1578-18 C-1-11\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2\n\n\n1.12 The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.107 (c)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 493.1241\r\n\n42 CFR Part 493.1274\r\n\n42 CFR Part 493.1283\r\n\nAAVLD Requirements for an AVMDL Sec. 5.8.2\r\n\nABFT Accreditation Manual D-3\r\n\nASTM E1578-18 C-1-12\r\n\nCAP Laboratory Accreditation Manual\r\n\nEPA ERLN Laboratory Requirements 3.2.2\r\n\nEPA ERLN Laboratory Requirements 4.1.11\r\n\nEPA ERLN Laboratory Requirements 4.4.10\r\n\nEPA QA\/G-5 2.2.3\r\n\nE.U. Commission Directive 2003\/94\/EC Article 15\r\n\nISO\/IEC 17025:2017 7.4.2\r\n\nOECD GLP Principles 6.2\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1.11\r\n\nUSDA Sampling Procedures for PDP 6.4.1.2.5\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2\r\n\nWHO Technical Report Series, #986, Annex 2, 17.11\n\n\n1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 58.107 (d)\r\n\n21 CFR Part 211.194\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 C-1-13\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 4.4.7\r\n\nEPA QA\/G-5 2.2.3\r\n\nOECD GLP Principles 6.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)\n\n\n1.14 The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.\n\n\n\n21 CFR Part 1.1149\r\n\nASTM E1578-18 C-1-14\r\n\nEPA ERLN Laboratory Requirements 4.4.6\n\n\n1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n\n\n\nACMG Technical Standards for Clinical Genetics Laboratories C3.3\r\n\nAAVLD Requirements for an AVMDL Sec. 5.8.3\r\n\nASTM E1492-11 4.1.1.5\r\n\nASTM E1492-11 4.1.6\r\n\nASTM E1492-11 4.3.3.2\r\n\nASTM E1578-18 C-1-15\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.3\r\n\nEPA ERLN Laboratory Requirements 4.4.13\r\n\nEPA ERLN Laboratory Requirements 4.11.8\r\n\nISO\/IEC 17025:2017 7.4.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137\r\n\nUSDA Sampling Procedures for PDP 6.4.1.1.9\r\n\nWADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1\n\n\n1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n\n\n\n21 CFR Part 1.1149\r\n\nA2LA C211 5.7\r\n\nASTM E1578-18 C-1-16\r\n\nEPA QA\/G-5 2.2.2 and 2.2.3\n\n\n1.17 The system should provide a means to document sample preparation activities for a given sample.\n\n\n\n7 CFR Part 331.11\r\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.11\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 1.1149\r\n\n21 CFR Part 1.1152 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1274\r\n\nA2LA C223 4.13\r\n\nA2LA C223 5.8\r\n\nABFT Accreditation Manual Sec. D-9\u201310\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1\r\n\nASTM E1492-11 (throughout)\r\n\nASTM E1578-18 C-1-17\r\n\nCLSI QMS22 2.2.3.5\r\n\nEPA 815-R-05-004 Chap. III, Sec. 12\r\n\nEPA 815-R-05-004 Appendix A\r\n\nEPA ERLN Laboratory Requirements 3.2.3\u20135\r\n\nEPA ERLN Laboratory Requirements 4.1.13\r\n\nEPA ERLN Laboratory Requirements 4.4.8\u20139\r\n\nEPA QA\/G-5 2.2.3\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3\r\n\nNIST 800-53, Rev. 5, AU-10(3)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)\r\n\nWADA International Standard for Laboratories (ISL) (throughout)\n\n\n1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n\n\n7 CFR Part 331.16\r\n9 CFR Part 121.16\r\n42 CFR Part 73.16\n\n1.19 In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.\n\n\nACMG Technical Standards for Clinical Genetics Laboratories G1.1\r\nAPHL 2019 LIS Project Management Guidebook\n\n1.20 The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.\n\n\n\n2. Sample management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 C-2-1\r\n\nEPA ERLN Laboratory Requirements 4.11.14\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2\n\n\n2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\n\n\nASTM E1578-18 C-2-2\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.\n\n\nASTM E1578-18 C-2-3\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\n\n\nASTM E1578-18 C-2-4\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.4 The system shall require the recording of a standard and reagent's first opening date.\n\n\nASTM E1578-18 C-2-5\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.5 The system shall allow only active standards and reagents to be shown as available for use.\n\n\nASTM E1578-18 C-2-6\r\nEPA ERLN Laboratory Requirements 4.11.14\n\n2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\n\n\nASTM E1578-18 C-2-7\n\n2.7 The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.\n\n\nASTM E1578-18 C-2-8\r\nEPA ERLN Laboratory Requirements 3.2\r\nISO\/IEC 17025:2017 7.4.2\n\n2.8 The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 211.84\r\n\n42 CFR Part 73.17\r\n\nASTM E1492-11 4.2.1\r\n\nASTM E1578-18 C-2-9\r\n\nCAP Laboratory Accreditation Manual\n\n\n2.9 The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\nA2LA C211 5.4\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1\r\nASTM E1578-18 C-2-10\n\n\n2.10 The system shall be able to link test methods and specifications to standards and reagents.\n\n\n\n21 CFR Part 1.1138\r\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1153 (c)\r\n\n21 CFR Part 111.315\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.84\r\n\n21 CFR Part 211.166\u20137\r\n\n21 CFR Part 211.194 (e)\r\n\n21 CFR Part 212.40 (c)\r\n\n21 CFR Part 212.61\r\n\n21 CFR Part 212.70 (e)\r\n\n21 CFR Part 225.58\r\n\n21 CFR Part 226.58\r\n\n21 CFR Part 606.65 (c)\r\n\n21 CFR Part 606.151\r\n\nA2LA C223 5.9\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C6.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C10\u201312\r\n\nCAP Laboratory Accreditation Manual\r\n\nASTM E1578-18 C-2-11\r\n\nEPA ERLN Laboratory Requirements 3.1.2.1\r\n\nEPA ERLN Laboratory Requirements 4.3.2\r\n\nEPA ERLN Laboratory Requirements 4.11.3.2\r\n\nEPA QA\/G-5 2.2.5\r\n\nISO\/IEC 17025:2017 7.7.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)\r\n\nUSDA Administrative Procedures for the PDP 8.5\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h\r\n\nWADA International Standard for Laboratories (ISL) 5.3.7\r\n\nWHO Technical Report Series, #961, Annex 13, 12.1\r\n\nWHO Technical Report Series, #986, Annex 2, 17.7\r\n\nWHO Technical Report Series, #986, Annex 2, 17.22\u201325\n\n\n2.11 The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n\n\n\n3. Core laboratory testing and experiments \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 111.315\r\n\n21 CFR Part 211.84 (d)\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1\r\n\nASTM E1578-18 C-3-1\r\n\nCLSI QMS22 2.2.2.1\r\n\nISO 15189:2012 5.3.2.7\r\n\nWADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\n\n\n\n21 CFR Part 211.84 (e)\r\n\n42 CFR Part 493.1252 (d)\r\n\nASTM E1578-18 C-3-2\r\n\nWADA International Standard for Laboratories (ISL) 5.2.7\n\n\n3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\n\n\n42 CFR Part 493.1252 (d)\r\nASTM E1578-18 C-3-3\n\n3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\n\n\nASTM E1578-18 C-3-4\n\n3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.\n\n\nASTM E1578-18 C-3-6\n\n3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\n\n\nASTM E1578-18 C-3-7\n\n3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\n\n\nASTM E1578-18 C-3-8\n\n3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\n\n\nASTM E1578-18 C-3-9\n\n3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\n\n\nASTM E1578-18 C-3-10\n\n3.9 The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\n\n\nAIHA-LAP Policies 2022 2A.7.8.2\r\nASTM E1578-18 C-3-11\n\n3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\n\n\nASTM E1578-18 C-3-12\n\n3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\n\n\n42 CFR Part 493.1241\r\nASTM E1578-18 C-3-13\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n3.12 The system should effectively alert users upon entry of out-of-specification test results.\n\n\n\n21 CFR Part 1.1150\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 1.1153 (c)\r\n\n21 CFR Part 106.100 (c\u2013f)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 111.325\r\n\n21 CFR Part 112.161\r\n\n21 CFR Part 114.100 (a)\r\n\n21 CFR Part 129.80 (g)\r\n\n21 CFR Part 211.194\r\n\n21 CFR Part 212.60 (g)\r\n\n21 CFR Part 507.202\r\n\n21 CFR Part 606.160\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G16.1\r\n\nA2LA C223 5.10\nASTM E1578-18 C-3-14\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.1\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.1.2\r\n\nCLSI QMS22 2.2.2.1\r\n\nEPA ERLN Laboratory Requirements 3.1.2.3\u20134\r\n\nEPA ERLN Laboratory Requirements 3.2\r\n\nEPA ERLN Laboratory Requirements 4.3.4\r\n\nEPA ERLN Laboratory Requirements 4.8.1\u20134\r\n\nEPA ERLN Laboratory Requirements 4.11.16\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nIFS Food 7, Part 2, 4.18.3\r\n\nIFS PACsecure 2, Part 2, 4.18.3\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.4.4.6\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6\r\n\nUSDA Data and Instrumentation for PDP 5.4.2\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\n\n\n3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\n\n\nWADA International Standard for Laboratories (ISL) 1.2\n\n3.14 The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\n\n\n\n4. Results review and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 493.1241\r\n\nASTM E1578-18 C-4-1\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.1.2\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.4.1\r\n\nISO 15189:2012 5.5.1.4\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n\n\n\nASTM E1578-18 C-4-2\r\n\nCLSI AUTO15 1.2\nEPA ERLN Laboratory Requirements 4.9.2\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.4.1\r\n\nISO 15189:2012 5.9.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\n\n\n4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\n\n\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 C-4-3\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nICH GCP 4.9.0 and 4.9.3\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n4.3 The system shall accurately maintain a full audit trail for modified results.\n\n\n\n21 CFR Part 1.1152 (c)\r\n\n21 CFR Part 111.110\r\n\n21 CFR Part 211.68 (b)\r\n\nA2LA C211 5.9.1\r\n\nA2LA C223 4.13\r\n\nABFT Accreditation Manual Sec. E-28\u201329\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G15.1\r\n\nAIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135\r\n\nASTM E1578-18 C-4-4\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.2.2\r\n\nEPA ERLN Laboratory Requirements 3.2.6\r\n\nEPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11\r\n\nEPA ERLN Laboratory Requirements 4.11.4\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\r\n\nIFS Food 7, Part 2, 5.6.4\r\n\nIFS PACsecure 2, Part 2, 5.6.4\r\n\nISO 15189:2012 5.7.1\r\n\nISO\/IEC 17025:2017 6.2.6\r\n\nISO\/IEC 17025:2017 7.7.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nNIST 800-53, Rev. 5, AU-10(3)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nUSDA Data and Instrumentation for PDP 10\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.1\r\n\nWHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1\n\n\n4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n\n\n\nASTM E1578-18 C-4-5\r\n\nBRC GSFS, Issue 8, 5.6.2.4\r\n\nBRC GSFS, Issue 8, 5.6.2.5\r\n\nEPA ERLN Laboratory Requirements 4.9.11\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\r\n\nIFS Food 7, Part 2, 5.6.4\r\n\nIFS PACsecure 2, Part 2, 5.6.4\r\n\nISO 15189:2012 5.9.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\n\n\n\nASTM E1578-18 C-4-6\r\n\nEPA QA\/G-5 2.2.10\r\n\nEPA QA\/G-5 2.4.1\r\n\nE.U. Annex 11-6\n\n\n4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\n\n\nCAP Laboratory Accreditation Manual\r\nCLSI AUTO15 4.0\r\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n4.7 The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n\n\n\n 5. Sample, experiment, and study approval and verification \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASTM E1578-18 C-5-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.2.3.5\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.9\u201310\r\n\nWADA International Standard for Laboratories (ISL) 5.3.12.1\n\n\n5.1 The system shall accurately record details of a sample or specimen's final disposition.\n\n\n\nAIHA-LAP Policies 2022 2A.7.7.2\r\n\nASTM E1578-18 C-5-2\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12\n\n\n5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\n\n\n21 CFR Part 211.160 (b)\r\nASTM E1578-18 C-5-3\r\nEPA 815-R-05-004 Chap. IV, Sec. 6.1\n\n5.3 The system should provide appropriate functions for specific sample statuses like \"approved\" and \"rejected,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\n\n\n\n6. Reporting \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 C-6-1\n\n6.1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\n\n\nEPA ERLN Laboratory Requirements 3.4\r\nEPA ERLN Laboratory Requirements 4.1.4\r\nEPA ERLN Laboratory Requirements 4.12\u201315\n\n6.2 The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\n\n\n\n42 CFR Part 493.1291 (g) and (h)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories F7.2\r\n\nASTM E1578-18 C-6-2\r\n\nCLSI QMS22 2.1.2.1\r\n\nEPA ERLN Laboratory Requirements 4.11.4\r\n\nEPA QA\/G-5 2.4.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n6.3 The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.\n\n\nABFT Accreditation Manual Sec. G-2\n\n6.4 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\n\n\n\n7 CFR Part 91.25\r\n\n21 CFR Part 1.1152 (d)\r\n\n40 CFR Part 141.33\r\n\n42 CFR Part 493.1291 (c\u2013e)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.2\u20135\r\n\nAIHA-LAP Policies 2022 2A.7.8.1\r\n\nABFT Accreditation Manual Sec. E-12 and -32\r\n\nASTM E1578-18 C-6-3\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8\r\n\nISO 15189:2012 4.5.2\r\n\nISO 15189:2012 5.8.3\r\n\nISO\/IEC 17025:2017 7.5.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nISO\/IEC 17025:2017 7.8.2.1\r\n\nISO\/IEC 17025:2017 7.8.3.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d\r\n\nWHO Technical Report Series, #986, Annex 2, 15.43\n\n\n6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.\n\n\n7 CFR Part 91.26\u201327\r\n21 CFR Part 1.1152 (d)\r\nASTM E1578-18 C-6-4\n\n6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n\n\n\nA2LA C211 5.10\r\n\nASTM E1578-18 C-6-5\r\n\nBRC GSFS, Issue 8, 5.6.1.2\r\n\nBRC GSFS, Issue 8, 9.3.5\r\n\nCLSI QMS22 2.2.3\r\n\nISO 15189:2012 5.8.1\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n\n\n\n7 CFR Part 331.5\r\n\n9 CFR Part 121.5\u20136\r\n\n21 CFR Part 1.1110\r\n\n21 CFR Part 1.1152 (a\u2013b)\r\n\n21 CFR Part 58.185\r\n\n21 CFR Part 312.64\r\n\n21 CFR Part 812.150\r\n\n40 CFR Part 141.31\r\n\n40 CFR Part 141.721\r\n\n40 CFR Part 370 Subpart C\r\n\n40 CFR Part 372 Subpart B\r\n\n40 CFR Part 704\r\n\n40 CFR Part 717 Subpart A\r\n\n40 CFR Part 720.40\r\n\n42 CFR Part 73.5\u20136\r\n\n42 CFR Part 493.43 (d)\r\n\nABFT Accreditation Manual Sec. E-7\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E8\r\n\nACMG Technical Standards for Clinical Genetics Laboratories G17.1\r\n\nASTM E1578-18 C-6-7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.3.1\r\n\nEPA ERLN Laboratory Requirements 4.12\u201315\r\n\nEPA QA\/G-5 2.3.2\r\n\nIFS Food 7, Part 4, 2.x\r\n\nIFS PACsecure 2, Part 4, 1.x\r\n\nNIST 800-53, Rev. 5, IR-6 and IR-6(1)\r\n\nOECD GLP Principles 9.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP (throughout)\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.4\n\n\n6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n\n\n\n7 CFR Part 91.28\r\n\n21 CFR Part 1.1154 (c)\r\n\n21 CFR Part 58 Sec. 58.185 (c)\r\n\nA2LA C211 5.10.9\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.9\u201310\r\n\nCLSI QMS22 2.2.3.4\r\n\nICH GCP 4.9.3\r\n\nISO\/IEC 17025:2017 7.8.8\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 9.1\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)\r\n\n\n\n6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n\n\n\nReferences \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Primary_laboratory_workflow\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Primary_laboratory_workflow<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:08.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed once.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","5fd4fe4c2259365fa0cb3f7c8d94a926_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Primary_laboratory_workflow rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Primary_laboratory_workflow skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Primary laboratory workflow<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<p><br \/>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"A2._Primary_laboratory_workflow\">A2. Primary laboratory workflow<\/span><\/h2>\n<p><b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> considers to be the core of your typical laboratory workflow, from sample\/specimen receipt and sampling procedures, to analysis, review, and reporting.<\/b>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"1._Sample_and_experiment_registration\">1. Sample and experiment registration<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.1<\/b> The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.101\" target=\"_blank\">21 CFR Part 211.101<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.80\" target=\"_blank\">21 CFR Part 226.80<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.120\" target=\"_blank\">21 CFR Part 606.120 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.121\" target=\"_blank\">21 CFR Part 606.121 (c\u2013i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.140\" target=\"_blank\">21 CFR Part 606.140 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096 (e1-6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1232\" target=\"_blank\">42 CFR Part 493.1232<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.2<\/b> The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.410\" target=\"_blank\">45 CFR Part 162.410<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.3<\/b> The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.4<\/b> The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.18\" target=\"_blank\">40 CFR Part 262.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.5<\/b> The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.6<\/b> The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.7<\/b> The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.8<\/b> The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.19\" target=\"_blank\">7 CFR Part 91.19<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.105 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.105\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.170\" target=\"_blank\">21 CFR Part 211.170<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1242\" target=\"_blank\">42 CFR Part 493.1242<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.7.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6 and 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=P1000PUE.txt\" target=\"_blank\">EPA 815-R-05-004 Supplement 1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10\u201311<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.7.1\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.9<\/b> The system shall be able to define the collection and sampling details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), sampling methods used, safety concerns, and retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.10<\/b> The system should allow for the addition of observations and descriptions to registered samples in the form of free text.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.11<\/b> The system should support the creation of user-definable default sample registration preferences and\/or input screens.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.12<\/b> The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual D-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.11<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.13<\/b> The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.107\" target=\"_blank\">21 CFR Part 58.107 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.14<\/b> The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.15<\/b> The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.1.3\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.4.1.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.16<\/b> The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.2 and 2.2.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.17<\/b> The system should provide a means to document sample preparation activities for a given sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1149<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1274\" target=\"_blank\">42 CFR Part 493.1274<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. D-9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-1-17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Appendix A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.3\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.4.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) (throughout)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.18<\/b> The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel\u2014including details such as unique identifier, name, location, date, and time\u2014while the sample is in the laboratory\u2019s possession.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.16\" target=\"_blank\">7 CFR Part 331.16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.16\" target=\"_blank\">9 CFR Part 121.16<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.16\" target=\"_blank\">42 CFR Part 73.16<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.19<\/b> In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.20<\/b> The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"2._Sample_management\">2. Sample management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.1<\/b> The system shall record and maintain the chain of custody for the laboratory's standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.2<\/b> The system shall record the current and historical storage location for the laboratory's standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.3<\/b> The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.4<\/b> The system shall require the recording of a standard and reagent's first opening date.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.5<\/b> The system shall allow only active standards and reagents to be shown as available for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.6<\/b> The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.7<\/b> The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>2.8<\/b> The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.9<\/b> The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-10<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.10<\/b> The system shall be able to link test methods and specifications to standards and reagents.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1138<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.166\" target=\"_blank\">21 CFR Part 211.166\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.40\" target=\"_blank\">21 CFR Part 212.40 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.61\" target=\"_blank\">21 CFR Part 212.61<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.70\" target=\"_blank\">21 CFR Part 212.70 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.65\" target=\"_blank\">21 CFR Part 606.65 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.151\" target=\"_blank\">21 CFR Part 606.151<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C6.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C10\u201312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-2-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 8.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13, 12.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.22\u201325<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.11<\/b> The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"3._Core_laboratory_testing_and_experiments\">3. Core laboratory testing and experiments<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.1<\/b> The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.84\" target=\"_blank\">21 CFR Part 211.84 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.2<\/b> The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1252\" target=\"_blank\">42 CFR Part 493.1252 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.3<\/b> The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.4<\/b> The system shall be able to check physical, control, and specification limits for an instrument sample.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.5<\/b> The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.6<\/b> The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.7<\/b> The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.8<\/b> The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.9<\/b> The system shall support, at a minimum, the floating point\/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.10<\/b> The system shall allow users to enter operators such as <, >, +, and - with numeric test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.11<\/b> The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.12<\/b> The system should effectively alert users upon entry of out-of-specification test results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1153 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (c\u2013f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.325<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.161<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.60\" target=\"_blank\">21 CFR Part 212.60 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G16.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.10<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-3-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.1.2.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.1\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section II.4.i<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 4.18.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 4.18.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.4.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 5.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>3.13<\/b> The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>3.14<\/b> The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"4._Results_review_and_verification\">4. Results review and verification<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1241\" target=\"_blank\">42 CFR Part 493.1241<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.5.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.1<\/b> The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 1.2<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.2<\/b> The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.0 and 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.3<\/b> The system shall accurately maintain a full audit trail for modified results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 4.13<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-28\u201329<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G15.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.2\u20133 and 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.2.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.4<\/b> The system shall provide one or more levels of review, as well as interpretation and documentation of results\u2014whether entered manually or via an automated process\u2014before release.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 5.6.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.5<\/b> The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-4-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-6<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>4.6<\/b> The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI AUTO15 4.0<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>4.7<\/b> The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span id=\"rdp-ebb-5._Sample,_experiment,_and_study_approval_and_verification\"><\/span><span class=\"mw-headline\" id=\"5._Sample.2C_experiment.2C_and_study_approval_and_verification\">5. Sample, experiment, and study approval and verification<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for PDP 5.9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.12.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>5.1<\/b> The system shall accurately record details of a sample or specimen's final disposition.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>5.2<\/b> The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-5-3<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>5.3<\/b> The system should provide appropriate functions for specific sample statuses like \"approved\" and \"rejected,\" including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"6._Reporting\">6. Reporting<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.1<\/b> The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.2<\/b> The system shall be able to export data in a computer-readable (importable into a relational database) format\u2014such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file\u2014as well as PDF format, for reporting purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (g) and (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories F7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.1.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.3<\/b> The system shall alert stakeholders in advance to cases when the analyzed sample may be out-of-specification or may not meet expected turnaround time requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. G-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.4<\/b> The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., \"less than X mg\/L\") when doing so would provide relevant information to the report recipient.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.25\" target=\"_blank\">7 CFR Part 91.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1291\" target=\"_blank\">42 CFR Part 493.1291 (c\u2013e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.2\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-12 and -32<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.43<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.5<\/b> The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.26\" target=\"_blank\">7 CFR Part 91.26\u201327<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>6.6<\/b> The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 5.6.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 9.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.7<\/b> The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, patient results, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.5\" target=\"_blank\">7 CFR Part 331.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.5\" target=\"_blank\">9 CFR Part 121.5\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (a\u2013b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58.185<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.64\" target=\"_blank\">21 CFR Part 312.64<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.150\" target=\"_blank\">21 CFR Part 812.150<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.31\" target=\"_blank\">40 CFR Part 141.31<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.721\" target=\"_blank\">40 CFR Part 141.721<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\/subpart-C\" target=\"_blank\">40 CFR Part 370 Subpart C<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\/subpart-B\" target=\"_blank\">40 CFR Part 372 Subpart B<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\/subpart-A\" target=\"_blank\">40 CFR Part 717 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.40\" target=\"_blank\">40 CFR Part 720.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.5\" target=\"_blank\">42 CFR Part 73.5\u20136<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.43\" target=\"_blank\">42 CFR Part 493.43 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories G17.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 C-6-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.12\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 4, 2.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 4, 1.x<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IR-6 and IR-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.3.8.4<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.8<\/b> The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, analytical worksheets, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.28\" target=\"_blank\">7 CFR Part 91.28<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.185\" target=\"_blank\">21 CFR Part 58 Sec. 58.185 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.10.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.10.9\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.8.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.10.9)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>6.9<\/b> The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<\/div>\n<!-- \nNewPP limit report\nCached time: 20230516220809\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.097 seconds\nReal time usage: 0.128 seconds\nPreprocessor visited node count: 516\/1000000\nPost\u2010expand include size: 156077\/2097152 bytes\nTemplate argument size: 24\/2097152 bytes\nHighest expansion depth: 7\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 60.816 1 -total\n 85.69% 52.112 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Primary_laboratory_workflow\n 15.18% 9.234 1 Template:LIMSpec\/Results_review_and_verification\n 13.97% 8.494 1 Template:Reflist\n 12.05% 7.329 1 Template:LIMSpec\/Sample_and_experiment_registration\n 11.56% 7.028 1 Template:LIMSpec\/Sample,_experiment,_and_study_approval_and_verification\n 10.11% 6.148 1 Template:LIMSpec\/Sample_management\n 9.28% 5.646 1 Template:LIMSpec\/Core_laboratory_testing_and_experiments\n 9.06% 5.508 1 Template:LIMSpec\/Reporting\n 6.52% 3.964 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14192-0!canonical and timestamp 20230516220811 and revision id 52017. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Primary_laboratory_workflow\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Primary_laboratory_workflow<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","5fd4fe4c2259365fa0cb3f7c8d94a926_images":[],"5fd4fe4c2259365fa0cb3f7c8d94a926_timestamp":1684275145,"00a9773130372b2ddd95ad56d5c39ac7_type":"article","00a9773130372b2ddd95ad56d5c39ac7_title":"A1. Introduction and methodology","00a9773130372b2ddd95ad56d5c39ac7_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Introduction_and_methodology","00a9773130372b2ddd95ad56d5c39ac7_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Introduction and methodologyFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 A1. Introduction and methodology \n\n1.1 Introduction \n1.2 Methodology \n\n\n2 References \n\n\n\nA1. Introduction and methodology \nIntroduction \nMerriam-Webster defines a \"specification\" as \"a detailed precise presentation of something or of a plan or proposal for something.\"[1] In other words, an existing or theoretical product, concept, or idea is presented in detail for a particular audience. In a broad sense, detailing the specifics about a project, concept, or idea to others is just common sense. This applies just as well to the world of software development, where a software requirements specification is essential for preventing the second most commonly cited reason for project failure: poor requirements management.[2] \nIn fact, the ISO\/IEC\/IEEE 29148:2018 standard (a conglomeration of what was formerly IEEE 830 and other standards) is in place to help specify \"the required processes implemented in the engineering activities that result in requirements for systems and software products\" and provides guidelines for how to apply those requirements.[3] The standard describes the characteristics that make up quality software requirement development, including aspects such as[4]:\n\ncorrectly describing system behavior;\neffectively removing ambiguity from the language used;\ncompletely covering the system behavior and features;\naccurately prioritizing and ranking the requirements; and\nunequivocally ensuring the requirements are testable, modifiable, and traceable.\nA requirement typically comes in the form of a statement that begins with \"the system\/user\/vendor shall\/should ...\" and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level) or specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered. An example of a functional software requirement could be \"the user shall be able to query either all of the initial set of databases or select a subset from it.\" This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state \"the system's query tool shall conform to the ABC 123-2014 standard.\" The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.[5]\nOver the years, a wide variety of companies, consultants, and researchers have compiled public and private software requirements specifications for laboratory informatics systems. These compiled lists of requirements for how a given laboratory informatics solution should be developed, delivered, and maintained have changed as technology and user demand have evolved. Often times, these requirements documents turn into a mix of \"wishlist\" requirements from potential and active clients, as well as regulation-mandated requirements. The wishlist items aren't necessarily ignored by developers, but they do in fact have to be prioritized as \"nice to have\" or \"essential to system operation,\" or something in between.[6][7][8] While this reasonable mix of requirements has served informatics software developers well[9], sometimes a fresh approach is required.\nWhat follows is an attempt to look less at the wishlists of laboratories and more directly at what requirements current regulatory schemes, industry standards, and organizational guidelines place on the ever-evolving array of laboratory informatics systems being developed today. What does the United States' 21 CFR Part 11 have to say about how your laboratory information management system (LIMS), laboratory information system (LIS), electronic laboratory notebook (ELN), and other systems operate? What does the European Union's Annex 11 dictate in those same regards? The following five chapters list those requirements, supported by one or more regulations, standards, and guidelines. The final chapter discusses how to best put this requirements specification to use.\n\nMethodology \nAt its core, this LIMSpec\u2014which has seen several iterations over the years\u2014is rooted in ASTM E1578-18 Standard Guide for Laboratory Informatics. The latest version was released in 2018, which includes an updated Laboratory Informatics Functional Requirements checklist in the appendix. That list of requirements \"covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide.\" It goes on to state that the checklist \"is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system,\" though it is certainly \"not meant to be exhaustive.\"\nThis LIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained. However, this should definitely be considered a work in progress, with more to be added with additional public and private comment on missing sources. \nThat said, this fourth revision (December 2022) taps into more than 130 resources, including the following:\n\n\n\n\n\n\n\nTable 1. Regulations, standards, guidance, and other documents guiding LIMSpec development. * indicates added, updated, or revised for December 2022 update.\n\n\nRegulation, Specification, or Guidance\n\nFamiliar Name and\/or Responsible Entity\n\n\n5 CFR Part 930.301\n\nOffice of Personnel Management > Civil Service Regulations > Programs for Specific Positions and Examinations (Miscellaneous) > Information Security Responsibilities for Employees who Manage or Use Federal Information Systems > Information systems security awareness training program\n\n\n7 CFR Part 91\n\nAgricultural Marketing Service (Standards, Inspections, Marketing Practices), Department of Agriculture > Commodity Laboratory Testing Programs > Services and General Information\n\n\n7 CFR Part 331\n\nAnimal and Plant Health Inspection Service, Department of Agriculture > Possession, Use, and Transfer of Select Agents and Toxins\n\n\n9 CFR Part 2\n\nAnimal and Plant Health Inspection Service, Department of Agriculture > Animal Welfare > Regulations\n\n\n9 CFR Part 121\n\nAnimal and Plant Health Inspection Service, Department of Agriculture > Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors > Possession, Use, and Transfer of Select Agents and Toxins\n\n\n10 CFR Part 20\n\nNuclear Regulatory Commission > Standards for Protection Against Radiation\n\n\n10 CFR Part 30\n\nNuclear Regulatory Commission > Rules of General Applicability to Domestic Licensing of Byproduct Material\n\n\n21 CFR Part 1*\n\nFood and Drug Administration, Department of Health and Human Services > General > General Enforcement Regulations\n\n\n21 CFR Part 7\n\nFood and Drug Administration, Department of Health and Human Services > General > Enforcement Policy\n\n\n21 CFR Part 11\n\nFood and Drug Administration, Department of Health and Human Services > General > Electronic Records; Electronic Signatures\n\n\n21 CFR Part 58\n\nFood and Drug Administration, Department of Health and Human Services > General > Good Laboratory Practice for Nonclinical Laboratory Studies\n\n\n21 CFR Part 106*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications\n\n\n21 CFR Part 110*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food\n\n\n21 CFR Part 111*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements\n\n\n21 CFR Part 112*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption\n\n\n21 CFR Part 114*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Acidified Foods\n\n\n21 CFR Part 117*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food\n\n\n21 CFR Part 120*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Hazard Analysis and Critical Control Point (HACCP) Systems\n\n\n21 CFR Part 123*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Fish and Fishery Products\n\n\n21 CFR Part 129*\n\nFood and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Processing and Bottling of Bottled Drinking Water\n\n\n21 CFR Part 211\n\nFood and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Finished Pharmaceuticals\n\n\n21 CFR Part 212\n\nFood and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Positron Emission Tomography Drugs\n\n\n21 CFR Part 225\n\nFood and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Medicated Feeds\n\n\n21 CFR Part 226\n\nFood and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Type A Medicated Articles\n\n\n21 CFR Part 312\n\nFood and Drug Administration, Department of Health and Human Services > Drugs for Human Use > Investigational New Drug Application\n\n\n21 CFR Part 507*\n\nFood and Drug Administration, Department of Health and Human Services > Animal Drugs, Feeds, and Related Products > Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals\n\n\n21 CFR Part 606\n\nFood and Drug Administration, Department of Health and Human Services > Biologics > Current Good Manufacturing Practice for Blood and Blood Components\n\n\n21 CFR Part 810\n\nFood and Drug Administration, Department of Health and Human Services > Medical Devices > Medical Device Recall Authority\n\n\n21 CFR Part 812\n\nFood and Drug Administration, Department of Health and Human Services > Medical Devices > Investigational Device Exemptions\n\n\n21 CFR Part 820\n\nFood and Drug Administration, Department of Health and Human Services > Medical Devices > Quality System Regulation\n\n\n29 CFR Part 1910.120\n\nOccupational Safety and Health Standards > Hazardous Materials > Hazardous waste operations and emergency response\n\n\n29 CFR Part 1910.134\n\nOccupational Safety and Health Standards > Personal Protective Equipment > Respiratory protection\n\n\n29 CFR Part 1910.1030\n\nOccupational Safety and Health Standards > Toxic and Hazardous Substances > Bloodborne pathogens\n\n\n29 CFR Part 1910.1096\n\nOccupational Safety and Health Standards > Toxic and Hazardous Substances > Ionizing radiation\n\n\n29 CFR Part 1910.1200\n\nOccupational Safety and Health Standards > Toxic and Hazardous Substances > Hazard communication\n\n\n29 CFR Part 1910.1450\n\nOccupational Safety and Health Standards > Toxic and Hazardous Substances > Occupational exposure to hazardous chemicals in laboratories\n\n\n40 CFR Part 3\n\nEnvironmental Protection Agency > General > Cross-media Electronic Reporting\n\n\n40 CFR Part 60\n\nEnvironmental Protection Agency > Air Programs > Standards of Performance for New Stationary Sources\n\n\n40 CFR Part 62\n\nEnvironmental Protection Agency > Air Programs > Approval and Promulgation of State Plans for Designated Facilities and Pollutants\n\n\n40 CFR Part 63\n\nEnvironmental Protection Agency > Air Programs > National Emission Standards for Hazardous Air Pollutants for Source Categories\n\n\n40 CFR Part 141\n\nEnvironmental Protection Agency > Water Programs > National Primary Drinking Water Regulations\n\n\n40 CFR Part 262\n\nEnvironmental Protection Agency > Solid Wastes > Standards Applicable to Generators of Hazardous Waste\n\n\n40 CFR Part 370\n\nEnvironmental Protection Agency > Superfund, Emergency Planning, and Community Right-to-know Programs > Hazardous Chemical Reporting: Community Right-to-know\n\n\n40 CFR Part 372\n\nEnvironmental Protection Agency > Superfund, Emergency Planning, and Community Right-to-know Programs > Toxic Chemical Release Reporting: Community Right-to-know\n\n\n40 CFR Part 704\n\nEnvironmental Protection Agency > Toxic Substances Control Act > Reporting and Recordkeeping Requirements\n\n\n40 CFR Part 717\n\nEnvironmental Protection Agency > Toxic Substances Control Act > Records and Reports of Allegations that Chemical Substances Cause Significant Adverse Reactions to Health or the Environment\n\n\n40 CFR Part 720\n\nEnvironmental Protection Agency > Toxic Substances Control Act > Premanufacture Notification\n\n\n42 CFR Part 73\n\nPublic Health Service, Department of Health and Human Services > Quarantine, Inspection, Licensing > Select Agents and Toxins\n\n\n42 CFR Part 93\n\nPublic Health Service, Department of Health and Human Services > Health Assessments and Health Effects Studies of Hazardous Substances Releases and Facilities > Public Health Service Policies on Research Misconduct\n\n\n42 CFR Part 493\n\nCenters for Medicare & Medicaid Services, Department of Health and Human Services > Standards and Certification > Laboratory Requirements\n\n\n45 CFR Part 160\n\nDepartment of Health and Human Services > Administrative Data Standards and Related Requirements > General Administrative Requirements\n\n\n45 CFR Part 162\n\nDepartment of Health and Human Services > Administrative Data Standards and Related Requirements > Administrative Requirements\n\n\n45 CFR Part 164\n\nDepartment of Health and Human Services > Administrative Data Standards and Related Requirements > Security and Privacy\n\n\n45 CFR Part 170\n\nDepartment of Health and Human Services > Health Information Technology > Health Information Technology Standards, Implementation Specifications, and Certification Criteria and Certification Programs for Health Information Technology\n\n\n61 FR 38806*\n\nFood Safety and Inspection Service, Department of Agriculture > Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems\n\n\nA2LA C211, Specific Checklist, Combined ISO\/IEC 17025 and Veterinary Laboratory Accreditation Program\n\nAmerican Association for Laboratory Accreditation\n\n\nA2LA C223, Specific Checklist, Forensic Examination Accreditation Program-Testing\n\nAmerican Association for Laboratory Accreditation\n\n\nAAFCO QA\/QC Guidelines for Feed Laboratories\n\nAssociation of American Feed Control Officials\n\n\nAAVLD Requirements for an AVMDL\n\nAmerican Association of Veterinary Laboratory Diagnosticians\n\n\nABFT Accreditation Manual\n\nAmerican Board of Forensic Toxicology\n\n\nACMG Technical Standards for Clinical Genetics Laboratories\n\nAmerican College of Medical Genetics and Genomics\n\n\nAIHA-LAP Policies 2022\n\nAmerican Industrial Hygiene Association Laboratory Accreditation Programs\n\n\nAPHL 2019 LIS Project Management Guidebook\n\nAssociation of Public Health Laboratories\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories\n\nAmerican Society of Crime Laboratory Directors\/Laboratory Accreditation Board; note that ASCLD\/LAB merged with ANAB (ANSI National Accreditation Board) in 2016, and their requirements for Forensic Service Provider Accreditation are not made public. As such, this serves as a proxy for ANAB.\n\n\nASTM E1188-11\n\nASTM E1188-11(2017) Standard Practice for Collection and Preservation of Information and Physical Items by a Technical Investigator\n\n\nASTM E1459-13\n\nASTM E1459-13(2018) Standard Guide for Physical Evidence Labeling and Related Documentation\n\n\nASTM E1492-11\n\nASTM E1492-11(2017) Standard Practice for Receiving, Documenting, Storing, and Retrieving Evidence in a Forensic Science Laboratory\n\n\nASTM E1578-18\n\nASTM E1578-18 Standard Guide for Laboratory Informatics\n\n\nBRC GSFS, Issue 8*\n\nBRC Global Standards' Global Standard for Food Safety, Issue 8\n\n\nCAP Laboratory Accreditation Manual\n\nCollege of American Pathologists\n\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL)\n\nU.S. Centers for Disease Control and Prevention\n\n\nCDC PHIN Messaging System\n\nU.S. Centers for Disease Control and Prevention\n\n\nCJIS Security Policy\n\nFederal Bureau of Investigation, Criminal Justice Information Services\n\n\nCLSI AUTO15\n\nClinical and Laboratory Standards Institute\n\n\nCLSI AUTO16\n\nClinical and Laboratory Standards Institute\n\n\nCLSI QMS22\n\nClinical and Laboratory Standards Institute\n\n\nCodex Alimentarius CXC 1-1969*\n\nFood and Agriculture Organization of the United Nations' Codex Alimentarius CXC 1-1969 General Principles of Good Hygiene\n\n\nCodex Alimentarius CXS 193-1995*\n\nFood and Agriculture Organization of the United Nations' Codex Alimentarius CXS 193-1995 General Standard for Contaminants and Toxins in Food and Feed\n\n\nCodex Alimentarius CXS 234-1999*\n\nFood and Agriculture Organization of the United Nations' Codex Alimentarius CXS 234-1999 Recommended Methods of Analysis and Sampling\n\n\nDoD General Data Validation Guidelines\n\nU.S. Department of Defense\n\n\nEMA Guidance on good manufacturing practice and good distribution practice\n\nE.U. European Medicines Agency\n\n\nEPA 815-R-05-004 + supplements\n\nU.S. Environmental Protection Agency\n\n\nEPA ERLN Laboratory Requirements v1.6\n\nU.S. Environmental Protection Agency, Environmental Response Laboratory Network\n\n\nEPA Metadata Technical Specification\n\nU.S. Environmental Protection Agency\n\n\nEPA QA\/G-5\n\nU.S. Environmental Protection Agency Guidance for Quality Assurance Project Plans\n\n\nEPA SEDD Specification and Data Element Dictionary v5.2\n\nU.S. Environmental Protection Agency Staged Electronic Data Deliverable\n\n\nE.U. Annex 11\n\nEuropean Union, European Commission\n\n\nE.U. Commission Directive 2003\/94\/EC\n\nEuropean Union, European Commission\n\n\nE.U. Commission Reg. No. 852\/2004*\n\nEuropean Union, European Commission\n\n\nE.U. Commission Reg. No. 2073\/2005*\n\nEuropean Union, European Commission\n\n\nFDA Office of Regulatory Affairs Data Exchange (ORA DX) Program\n\nU.S. Food and Drug Administration\n\n\nFDA Hazard Analysis Critical Control Point (HACCP)\n\nU.S. Food and Drug Administration\n\n\nGFSI Benchmarking Rqmts., v2020.1*\n\nGlobal Food Safety Initiative Benchmarking Requirements Version 2020.1\n\n\nICAR 15 Data Exchange\n\nInternational Committee for Animal Recording\n\n\nICH GCP\n\nInternational Council for Harmonisation Good Clinical Practice\n\n\nIFS Food 7*\n\nInternational Featured Standards' Food 7 Standard\n\n\nIFS PACsecure 2*\n\nInternational Featured Standards' PACsecure 2 Standard\n\n\nISO 15189:2012\n\nISO 15189:2012 Medical laboratories \u2014 Requirements for quality and competence\n\n\nISO\/IEC 17025:2017\n\nISO\/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories\n\n\nISO\/TS 22002-1:2009*\n\nISO\/TS 22002-1:2009 Prerequisite programmes on food safety \u2014 Part 1: Food manufacturing\n\n\nISO\/TS 22002-4:2013*\n\nISO\/TS 22002-4:2013 Prerequisite programmes on food safety \u2014 Part 4: Food packaging manufacturing\n\n\nISO\/TS 22002-6:2016*\n\nISO\/TS 22002-6:2016 Prerequisite programmes on food safety \u2014 Part 6: Feed and animal food production\n\n\nNAHLN HL7 Messaging Quick User Guide\n\nNational Animal Health Laboratory Network\n\n\nNAHLN Information Technology System\n\nNational Animal Health Laboratory Network\n\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\nNew York State Department of Health Clinical Laboratory Evaluation Program\n\n\nNYSDOH ELAP Medical Marijuana Microbiology Guidance\n\nNew York State Department of Health Environmental Laboratory Approval Program\n\n\nNIST 800-53, Rev. 5\n\nNational Institute of Standards and Technology\n\n\nOECD GLP Principles\n\nOrganisation for Economic Co-operation and Development Good Laboratory Practice\n\n\nONC United States Core Data for Interoperability (USCDI)\n\nOffice of the National Coordinator for Health Information Technology\n\n\nOSHA 1910.1020\n\nOccupational Safety and Health Administration 1910.1020 - Access to employee exposure and medical records\n\n\nOSHA 1910.1200\n\nOccupational Safety and Health Administration 1910.1200 - Hazard Communication\n\n\nOSHA 1910.1450\n\nOccupational Safety and Health Administration 1910.1450 - Occupational exposure to hazardous chemicals in laboratories\n\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\n\nPartnership for Food Protection\n\n\nSafe Food for Canadians Regulations SOR\/2018-108*\n\nGovernment of Canada, Governor General of Canada\n\n\nSQF FSC 9, Food Manufacturing*\n\nFMI, The Food Industry Association, SQF Institute's Food Safety Code: Manufacture of Food Packaging, Ninth Edition\n\n\nSQF FSC 9, Pet Food Manufacturing*\n\nFMI, The Food Industry Association, SQF Institute's Food Safety Code: Pet Food Manufacturing, Ninth Edition\n\n\nSQF FSC 9, Manufacture of Food Packaging*\n\nFMI, The Food Industry Association, SQF Institute's Food Safety Code: Manufacture of Food Packaging, Ninth Edition\n\n\nTNI EL-V1-2016-Rev.2.1\n\nThe NELAC Institute Management and Technical Requirements for Laboratories Performing Environmental Analysis, Volume 1\n\n\nUSDA Administrative Procedures for the Pesticide Data Program (PDP)\n\nU.S. Department of Agriculture\n\n\nUSDA Data and Instrumentation for Pesticide Data Program\n\nU.S. Department of Agriculture\n\n\nUSDA Hemp Production Program Laboratory Testing Guidelines\n\nU.S. Department of Agriculture\n\n\nUSDA Laboratory Approval Service (LAS) Laboratory Approval Program (LAP) Policies and Procedures\n\nU.S. Department of Agriculture\n\n\nUSDA Sample Processing and Analysis Procedures for Pesticide Data Program\n\nU.S. Department of Agriculture\n\n\nUSDA Sampling Procedures for Pesticide Data Program\n\nU.S. Department of Agriculture\n\n\nVeNom Coding Group terminology\n\nVeterinary Nomenclature\n\n\nVTSL terminology\n\nVeterinary Terminology Services Laboratory at Virginia-Maryland College of Veterinary Medicine\n\n\nVICH GL53\n\nVeterinary International Conference on Harmonization GL53 Electronic Exchange of Documents: Electronic File Format\n\n\nWADA International Standard for Laboratories (ISL)\n\nWorld Anti-Doping Agency\n\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI)\n\nWorld Anti-Doping Agency\n\n\nWHO Technical Report Series, #961, Annex 13\n\nWorld Health Organization TRS, #961, Annex 13 Guidelines for preparing a laboratory information file\n\n\nWHO Technical Report Series, #986, Annex 2\n\nWorld Health Organization TRS, #986, Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles\n\n\nWHO Technical Report Series, #996, Annex 5\n\nWorld Health Organization TRS, #996, Annex 5 Guidance on good data and record management practices\n\n\n\nEach requirement statement has at least one linked regulation, standard, or guidance item. In some cases, the standards covered are proprietary. In those cases, the standard was either purchased for review or heavily researched using supporting documentation, and the link goes to the acquisition page for the standard. In other cases, some sources have been intentionally omitted. For example, the AOAC International Official Methods of Analysis and Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals are both proprietary and more or less prohibitively expensive. In other cases, such as with the U.S. Food Emergency Response Network and Laboratory Response Network, they simply don't make their standardized procedures open to the public and thus can't be included.\n\nReferences \n\n\n\u2191 \"specification\". Merriam-Webster. Merriam-Webster, Inc. https:\/\/www.merriam-webster.com\/dictionary\/specification . Retrieved 07 December 2022 .   \n \n\n\u2191 Bieg, D.P. (August 2014). \"Introduction\" (PDF). Requirements Management: A Core Competency for Project and Program Success. Project Management Institute. p. 3. https:\/\/www.pmi.org\/-\/media\/pmi\/documents\/public\/pdf\/learning\/thought-leadership\/pulse\/requirements-management.pdf . Retrieved 07 December 2022 .   \n \n\n\u2191 \"ISO\/IEC\/IEEE 29148:2018\". International Organization for Standardization. November 2018. https:\/\/www.iso.org\/standard\/72089.html . Retrieved 07 December 2022 .   \n \n\n\u2191 Seibert, P. (28 July 2011). \"How do you write software requirements? What are software requirements? What is a software requirement?\". HubTechInsider. https:\/\/hubtechinsider.wordpress.com\/2011\/07\/28\/how-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 Memon, A. (Spring 2010). \"Software Requirements: Descriptions and specifications of a system\" (PDF). University of Maryland. https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf . Retrieved 07 December 2022 .   \n \n\n\u2191 Aasem, M.; Ramzan, M.; Jaffar, A. (2010). \"Analysis and optimization of software requirements prioritization techniques\". Proceedings from the 2010 International Conference on Information and Emerging Technologies: 1\u20136. doi:10.1109\/ICIET.2010.5625687.   \n \n\n\u2191 Hirsch, J. (22 November 2013). \"10 Steps To Successful Requirements Gathering\". Phase2 Technology, LLC. https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering . Retrieved 07 December 2022 .   \n \n\n\u2191 Burris, E. (2007). \"Requirements Specification\". CS451R, University of Missouri\u2013Kansas City. University of Missouri\u2013Kansas City. Archived from the original on 24 July 2019. https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 Hofmann, H.F.; Lehner, F. (2001). \"Requirements engineering as a success factor in software projects\". IEEE Software 18 (4): 58\u201366. doi:10.1109\/MS.2001.936219.   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Introduction_and_methodology\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Introduction_and_methodology<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:07.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed once.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","00a9773130372b2ddd95ad56d5c39ac7_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Introduction_and_methodology rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Introduction_and_methodology skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Introduction and methodology<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h2><span class=\"mw-headline\" id=\"A1._Introduction_and_methodology\">A1. Introduction and methodology<\/span><\/h2>\n<h3><span class=\"mw-headline\" id=\"Introduction\">Introduction<\/span><\/h3>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Systems_Requirement_Analysis.jpg\" class=\"image wiki-link\" data-key=\"cdbc7c51db09035738b016eb74416252\"><img alt=\"Systems Requirement Analysis.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/9\/9b\/Systems_Requirement_Analysis.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>Merriam-Webster defines a \"specification\" as \"a detailed precise presentation of something or of a plan or proposal for something.\"<sup id=\"rdp-ebb-cite_ref-MWSpec_1-0\" class=\"reference\"><a href=\"#cite_note-MWSpec-1\">[1]<\/a><\/sup> In other words, an existing or theoretical product, concept, or idea is presented in detail for a particular audience. In a broad sense, detailing the specifics about a project, concept, or idea to others is just common sense. This applies just as well to the world of software development, where a software requirements specification is essential for preventing the second most commonly cited reason for project failure: poor requirements management.<sup id=\"rdp-ebb-cite_ref-BiegRequire14_2-0\" class=\"reference\"><a href=\"#cite_note-BiegRequire14-2\">[2]<\/a><\/sup> \n<\/p><p>In fact, the ISO\/IEC\/IEEE 29148:2018 standard (a conglomeration of what was formerly IEEE 830 and other standards) is in place to help specify \"the required processes implemented in the engineering activities that result in requirements for systems and software products\" and provides guidelines for how to apply those requirements.<sup id=\"rdp-ebb-cite_ref-ISO29148_3-0\" class=\"reference\"><a href=\"#cite_note-ISO29148-3\">[3]<\/a><\/sup> The standard describes the characteristics that make up quality software requirement development, including aspects such as<sup id=\"rdp-ebb-cite_ref-SeibertHowDoYou11_4-0\" class=\"reference\"><a href=\"#cite_note-SeibertHowDoYou11-4\">[4]<\/a><\/sup>:\n<\/p>\n<ul><li>correctly describing system behavior;<\/li>\n<li>effectively removing ambiguity from the language used;<\/li>\n<li>completely covering the system behavior and features;<\/li>\n<li>accurately prioritizing and ranking the requirements; and<\/li>\n<li>unequivocally ensuring the requirements are testable, modifiable, and traceable.<\/li><\/ul>\n<p>A requirement typically comes in the form of a statement that begins with \"the system\/user\/vendor shall\/should ...\" and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level) or specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered. An example of a functional software requirement could be \"the user shall be able to query either all of the initial set of databases or select a subset from it.\" This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state \"the system's query tool shall conform to the ABC 123-2014 standard.\" The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.<sup id=\"rdp-ebb-cite_ref-MemonSoftware10_5-0\" class=\"reference\"><a href=\"#cite_note-MemonSoftware10-5\">[5]<\/a><\/sup>\n<\/p><p>Over the years, a wide variety of companies, consultants, and researchers have compiled public and private software requirements specifications for <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> systems. These compiled lists of requirements for how a given laboratory informatics solution should be developed, delivered, and maintained have changed as technology and user demand have evolved. Often times, these requirements documents turn into a mix of \"wishlist\" requirements from potential and active clients, as well as regulation-mandated requirements. The wishlist items aren't necessarily ignored by developers, but they do in fact have to be prioritized as \"nice to have\" or \"essential to system operation,\" or something in between.<sup id=\"rdp-ebb-cite_ref-AasemAnalysis10_6-0\" class=\"reference\"><a href=\"#cite_note-AasemAnalysis10-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Hirsch10Steps13_7-0\" class=\"reference\"><a href=\"#cite_note-Hirsch10Steps13-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BurrissSoftware07_8-0\" class=\"reference\"><a href=\"#cite_note-BurrissSoftware07-8\">[8]<\/a><\/sup> While this reasonable mix of requirements has served informatics software developers well<sup id=\"rdp-ebb-cite_ref-HofmannRequire01_9-0\" class=\"reference\"><a href=\"#cite_note-HofmannRequire01-9\">[9]<\/a><\/sup>, sometimes a fresh approach is required.\n<\/p><p>What follows is an attempt to look less at the wishlists of laboratories and more directly at what requirements current regulatory schemes, industry standards, and organizational guidelines place on the ever-evolving array of laboratory informatics systems being developed today. What does the United States' <a href=\"https:\/\/www.limswiki.org\/index.php\/21_CFR_Part_11\" title=\"21 CFR Part 11\" class=\"wiki-link\" data-key=\"0ec495c20a8f17894bd0c1388eda8e7a\">21 CFR Part 11<\/a> have to say about how your <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS), <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\" title=\"Laboratory information system\" class=\"wiki-link\" data-key=\"37add65b4d1c678b382a7d4817a9cf64\">laboratory information system<\/a> (LIS), <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_laboratory_notebook\" title=\"Electronic laboratory notebook\" class=\"wiki-link\" data-key=\"a9fbbd5e0807980106763fab31f1e72f\">electronic laboratory notebook<\/a> (ELN), and other systems operate? What does the European Union's Annex 11 dictate in those same regards? The following five chapters list those requirements, supported by one or more regulations, standards, and guidelines. The final chapter discusses how to best put this requirements specification to use.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Methodology\">Methodology<\/span><\/h3>\n<p>At its core, this LIMSpec\u2014which has seen several iterations over the years\u2014is rooted in <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> <i>Standard Guide for Laboratory Informatics<\/i>. The latest version was released in 2018, which includes an updated Laboratory Informatics Functional Requirements checklist in the appendix. That list of requirements \"covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide.\" It goes on to state that the checklist \"is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system,\" though it is certainly \"not meant to be exhaustive.\"\n<\/p><p>This LIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained. However, this should definitely be considered a work in progress, with more to be added with additional public and private comment on missing sources. \n<\/p><p>That said, this fourth revision (December 2022) taps into more than 130 resources, including the following:\n<\/p>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<td colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\"><b>Table 1.<\/b> Regulations, standards, guidance, and other documents guiding LIMSpec development. <sup>*<\/sup> indicates added, updated, or revised for December 2022 update.\n<\/td><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Familiar Name and\/or Responsible Entity\n<\/th><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Office of Personnel Management > Civil Service Regulations > Programs for Specific Positions and Examinations (Miscellaneous) > Information Security Responsibilities for Employees who Manage or Use Federal Information Systems > Information systems security awareness training program\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-91\" target=\"_blank\">7 CFR Part 91<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Agricultural Marketing Service (Standards, Inspections, Marketing Practices), Department of Agriculture > Commodity Laboratory Testing Programs > Services and General Information\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/part-331\" target=\"_blank\">7 CFR Part 331<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Animal and Plant Health Inspection Service, Department of Agriculture > Possession, Use, and Transfer of Select Agents and Toxins\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-2\" target=\"_blank\">9 CFR Part 2<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Animal and Plant Health Inspection Service, Department of Agriculture > Animal Welfare > Regulations\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/part-121\" target=\"_blank\">9 CFR Part 121<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Animal and Plant Health Inspection Service, Department of Agriculture > Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors > Possession, Use, and Transfer of Select Agents and Toxins\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-20\" target=\"_blank\">10 CFR Part 20<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Nuclear Regulatory Commission > Standards for Protection Against Radiation\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/part-30\" target=\"_blank\">10 CFR Part 30<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Nuclear Regulatory Commission > Rules of General Applicability to Domestic Licensing of Byproduct Material\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > General > General Enforcement Regulations\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-7\" target=\"_blank\">21 CFR Part 7<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > General > Enforcement Policy\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-11\" target=\"_blank\">21 CFR Part 11<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > General > Electronic Records; Electronic Signatures\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-58\" target=\"_blank\">21 CFR Part 58<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > General > Good Laboratory Practice for Nonclinical Laboratory Studies\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-110\" target=\"_blank\">21 CFR Part 110<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-111\" target=\"_blank\">21 CFR Part 111<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Acidified Foods\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Hazard Analysis and Critical Control Point (HACCP) Systems\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Fish and Fishery Products\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Food for Human Consumption > Processing and Bottling of Bottled Drinking Water\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-211\" target=\"_blank\">21 CFR Part 211<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Finished Pharmaceuticals\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-212\" target=\"_blank\">21 CFR Part 212<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Positron Emission Tomography Drugs\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-225\" target=\"_blank\">21 CFR Part 225<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Medicated Feeds\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-226\" target=\"_blank\">21 CFR Part 226<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Drugs: General > Current Good Manufacturing Practice for Type A Medicated Articles\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-312\" target=\"_blank\">21 CFR Part 312<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Drugs for Human Use > Investigational New Drug Application\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Animal Drugs, Feeds, and Related Products > Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-606\" target=\"_blank\">21 CFR Part 606<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Biologics > Current Good Manufacturing Practice for Blood and Blood Components\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-810\" target=\"_blank\">21 CFR Part 810<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Medical Devices > Medical Device Recall Authority\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-812\" target=\"_blank\">21 CFR Part 812<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Medical Devices > Investigational Device Exemptions\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-820\" target=\"_blank\">21 CFR Part 820<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Drug Administration, Department of Health and Human Services > Medical Devices > Quality System Regulation\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Standards > Hazardous Materials > Hazardous waste operations and emergency response\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.134\" target=\"_blank\">29 CFR Part 1910.134<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Standards > Personal Protective Equipment > Respiratory protection\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Standards > Toxic and Hazardous Substances > Bloodborne pathogens\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Standards > Toxic and Hazardous Substances > Ionizing radiation\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Standards > Toxic and Hazardous Substances > Hazard communication\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Standards > Toxic and Hazardous Substances > Occupational exposure to hazardous chemicals in laboratories\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-3\" target=\"_blank\">40 CFR Part 3<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > General > Cross-media Electronic Reporting\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-60\" target=\"_blank\">40 CFR Part 60<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Air Programs > Standards of Performance for New Stationary Sources\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-62\" target=\"_blank\">40 CFR Part 62<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Air Programs > Approval and Promulgation of State Plans for Designated Facilities and Pollutants\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-63\" target=\"_blank\">40 CFR Part 63<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Air Programs > National Emission Standards for Hazardous Air Pollutants for Source Categories\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-141\" target=\"_blank\">40 CFR Part 141<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Water Programs > National Primary Drinking Water Regulations\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-262\" target=\"_blank\">40 CFR Part 262<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Solid Wastes > Standards Applicable to Generators of Hazardous Waste\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-370\" target=\"_blank\">40 CFR Part 370<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Superfund, Emergency Planning, and Community Right-to-know Programs > Hazardous Chemical Reporting: Community Right-to-know\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-372\" target=\"_blank\">40 CFR Part 372<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Superfund, Emergency Planning, and Community Right-to-know Programs > Toxic Chemical Release Reporting: Community Right-to-know\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\" target=\"_blank\">40 CFR Part 704<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Toxic Substances Control Act > Reporting and Recordkeeping Requirements\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-717\" target=\"_blank\">40 CFR Part 717<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Toxic Substances Control Act > Records and Reports of Allegations that Chemical Substances Cause Significant Adverse Reactions to Health or the Environment\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-720\" target=\"_blank\">40 CFR Part 720<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Environmental Protection Agency > Toxic Substances Control Act > Premanufacture Notification\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-73\" target=\"_blank\">42 CFR Part 73<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Public Health Service, Department of Health and Human Services > Quarantine, Inspection, Licensing > Select Agents and Toxins\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-93\" target=\"_blank\">42 CFR Part 93<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Public Health Service, Department of Health and Human Services > Health Assessments and Health Effects Studies of Hazardous Substances Releases and Facilities > Public Health Service Policies on Research Misconduct\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/part-493\" target=\"_blank\">42 CFR Part 493<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Centers for Medicare & Medicaid Services, Department of Health and Human Services > Standards and Certification > Laboratory Requirements\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-160\" target=\"_blank\">45 CFR Part 160<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Department of Health and Human Services > Administrative Data Standards and Related Requirements > General Administrative Requirements\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-162\" target=\"_blank\">45 CFR Part 162<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Department of Health and Human Services > Administrative Data Standards and Related Requirements > Administrative Requirements\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-164\" target=\"_blank\">45 CFR Part 164<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Department of Health and Human Services > Administrative Data Standards and Related Requirements > Security and Privacy\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/part-170\" target=\"_blank\">45 CFR Part 170<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Department of Health and Human Services > Health Information Technology > Health Information Technology Standards, Implementation Specifications, and Certification Criteria and Certification Programs for Health Information Technology\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food Safety and Inspection Service, Department of Agriculture > Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211, Specific Checklist, Combined ISO\/IEC 17025 and Veterinary Laboratory Accreditation Program<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">American Association for Laboratory Accreditation\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223, Specific Checklist, Forensic Examination Accreditation Program-Testing<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">American Association for Laboratory Accreditation\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Association of American Feed Control Officials\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">American Association of Veterinary Laboratory Diagnosticians\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">American Board of Forensic Toxicology\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">American College of Medical Genetics and Genomics\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2022<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">American Industrial Hygiene Association Laboratory Accreditation Programs\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Association of Public Health Laboratories\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">American Society of Crime Laboratory Directors\/Laboratory Accreditation Board; note that ASCLD\/LAB merged with ANAB (ANSI National Accreditation Board) in 2016, and their requirements for Forensic Service Provider Accreditation are not made public. As such, this serves as a proxy for ANAB.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1188-11r17.html\" target=\"_blank\">ASTM E1188-11<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ASTM E1188-11(2017) <i>Standard Practice for Collection and Preservation of Information and Physical Items by a Technical Investigator<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1459-13r18.html\" target=\"_blank\">ASTM E1459-13<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ASTM E1459-13(2018) <i>Standard Guide for Physical Evidence Labeling and Related Documentation<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ASTM E1492-11(2017) <i>Standard Practice for Receiving, Documenting, Storing, and Retrieving Evidence in a Forensic Science Laboratory<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ASTM E1578-18 <i>Standard Guide for Laboratory Informatics<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">BRC Global Standards' Global Standard for Food Safety, Issue 8\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">College of American Pathologists\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL)<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Centers for Disease Control and Prevention\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/phin\/tools\/phinms\/index.html\" target=\"_blank\">CDC PHIN Messaging System<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Centers for Disease Control and Prevention\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Federal Bureau of Investigation, Criminal Justice Information Services\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/automation-and-informatics\/documents\/auto15\/\" target=\"_blank\">CLSI AUTO15<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Clinical and Laboratory Standards Institute\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/automation-and-informatics\/documents\/auto16\/\" target=\"_blank\">CLSI AUTO16<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Clinical and Laboratory Standards Institute\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Clinical and Laboratory Standards Institute\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Agriculture Organization of the United Nations' Codex Alimentarius CXC 1-1969 <i>General Principles of Good Hygiene<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf\" target=\"_blank\">Codex Alimentarius CXS 193-1995<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Agriculture Organization of the United Nations' Codex Alimentarius CXS 193-1995 <i>General Standard for Contaminants and Toxins in Food and Feed<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B234-1999%252FCXS_234e.pdf\" target=\"_blank\">Codex Alimentarius CXS 234-1999<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Food and Agriculture Organization of the United Nations' Codex Alimentarius CXS 234-1999 <i>Recommended Methods of Analysis and Sampling<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/denix.osd.mil\/edqw\/documents\/documents\/gen-data-validation-rev1\/\" target=\"_blank\">DoD General Data Validation Guidelines<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Department of Defense\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on good manufacturing practice and good distribution practice<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">E.U. European Medicines Agency\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/dwlabcert\/laboratory-certification-manual-drinking-water\" target=\"_blank\">EPA 815-R-05-004 + supplements<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Environmental Protection Agency\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/emergency-response\/environmental-response-laboratory-network-erln-laboratory-requirements\" target=\"_blank\">EPA ERLN Laboratory Requirements v1.6<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Environmental Protection Agency, Environmental Response Laboratory Network\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/geospatial\/epa-metadata-technical-specification\" target=\"_blank\">EPA Metadata Technical Specification<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Environmental Protection Agency\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Environmental Protection Agency Guidance for Quality Assurance Project Plans\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi\/P100WP4J.PDF?Dockey=P100WP4J.PDF\" target=\"_blank\">EPA SEDD Specification and Data Element Dictionary v5.2<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Environmental Protection Agency Staged Electronic Data Deliverable\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">European Union, European Commission\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">European Union, European Commission\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">European Union, European Commission\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02005R2073-20200308\" target=\"_blank\">E.U. Commission Reg. No. 2073\/2005<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">European Union, European Commission\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/orapartners.fda.gov\/cs\/groups\/public\/documents\/document\/b2hh\/bmri\/~edisp\/rpohandbook.pdf\" target=\"_blank\">FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Food and Drug Administration\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/hazard-analysis-critical-control-point-haccp\/haccp-principles-application-guidelines\" target=\"_blank\">FDA Hazard Analysis Critical Control Point (HACCP)<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Food and Drug Administration\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Global Food Safety Initiative Benchmarking Requirements Version 2020.1\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icar.org\/Guidelines\/15-Data-Exchange.pdf\" target=\"_blank\">ICAR 15 Data Exchange<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">International Committee for Animal Recording\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">International Council for Harmonisation Good Clinical Practice\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">International Featured Standards' Food 7 Standard\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">International Featured Standards' PACsecure 2 Standard\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ISO 15189:2012 <i>Medical laboratories \u2014 Requirements for quality and competence<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ISO\/IEC 17025:2017 <i>General requirements for the competence of testing and calibration laboratories<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">ISO\/TS 22002-1:2009<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ISO\/TS 22002-1:2009 <i>Prerequisite programmes on food safety \u2014 Part 1: Food manufacturing<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">ISO\/TS 22002-4:2013<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ISO\/TS 22002-4:2013 <i>Prerequisite programmes on food safety \u2014 Part 4: Food packaging manufacturing<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">ISO\/TS 22002-6:2016<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ISO\/TS 22002-6:2016 <i>Prerequisite programmes on food safety \u2014 Part 6: Feed and animal food production<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/animal_health\/nahln\/downloads\/MessagingQuickGuide.pdf\" target=\"_blank\">NAHLN HL7 Messaging Quick User Guide<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">National Animal Health Laboratory Network\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20170509221853\/https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/lab-info-services\/nahln\/ct_nahln_it\" target=\"_blank\">NAHLN Information Technology System<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">National Animal Health Laboratory Network\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">New York State Department of Health Clinical Laboratory Evaluation Program\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">NYSDOH ELAP Medical Marijuana Microbiology Guidance<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">New York State Department of Health Environmental Laboratory Approval Program\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">National Institute of Standards and Technology\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Organisation for Economic Co-operation and Development Good Laboratory Practice\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthit.gov\/isa\/united-states-core-data-interoperability-uscdi\" target=\"_blank\">ONC United States Core Data for Interoperability (USCDI)<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Office of the National Coordinator for Health Information Technology\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Administration 1910.1020 - <i>Access to employee exposure and medical records<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1200<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Administration 1910.1200 - <i>Hazard Communication<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Occupational Safety and Health Administration 1910.1450 - <i>Occupational exposure to hazardous chemicals in laboratories<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Partnership for Food Protection\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Government of Canada, Governor General of Canada\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">FMI, The Food Industry Association, SQF Institute's Food Safety Code: Manufacture of Food Packaging, Ninth Edition\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">FMI, The Food Industry Association, SQF Institute's Food Safety Code: Pet Food Manufacturing, Ninth Edition\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging<\/a><sup>*<\/sup>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">FMI, The Food Industry Association, SQF Institute's Food Safety Code: Manufacture of Food Packaging, Ninth Edition\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">The NELAC Institute <i>Management and Technical Requirements for Laboratories Performing Environmental Analysis<\/i>, Volume 1\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the Pesticide Data Program (PDP)<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Department of Agriculture\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for Pesticide Data Program<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Department of Agriculture\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Department of Agriculture\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA Laboratory Approval Service (LAS) Laboratory Approval Program (LAP) Policies and Procedures<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Department of Agriculture\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sample Processing and Analysis Procedures for Pesticide Data Program<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Department of Agriculture\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for Pesticide Data Program<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Department of Agriculture\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/venomcoding.org\/\" target=\"_blank\">VeNom Coding Group terminology<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Veterinary Nomenclature\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vtsl.vetmed.vt.edu\/\" target=\"_blank\">VTSL terminology<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Veterinary Terminology Services Laboratory at Virginia-Maryland College of Veterinary Medicine\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vichsec.org\/en\/guidelines\/general\" target=\"_blank\">VICH GL53<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Veterinary International Conference on Harmonization GL53 <i>Electronic Exchange of Documents: Electronic File Format<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL)<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">World Anti-Doping Agency\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI)<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">World Anti-Doping Agency\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #961, Annex 13<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">World Health Organization TRS, #961, Annex 13 <i>Guidelines for preparing a laboratory information file<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/pqweb\/medicines\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">World Health Organization TRS, #986, Annex 2 <i>WHO good manufacturing practices for pharmaceutical products: main principles<\/i>\n<\/td><\/tr>\n<tr>\n<td style=\"padding:10px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">World Health Organization TRS, #996, Annex 5 <i>Guidance on good data and record management practices<\/i>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<p>Each requirement statement has at least one linked regulation, standard, or guidance item. In some cases, the standards covered are proprietary. In those cases, the standard was either purchased for review or heavily researched using supporting documentation, and the link goes to the acquisition page for the standard. In other cases, some sources have been intentionally omitted. For example, the AOAC International <i>Official Methods of Analysis<\/i> and <i>Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals<\/i> are both proprietary and more or less prohibitively expensive. In other cases, such as with the U.S. Food Emergency Response Network and Laboratory Response Network, they simply don't make their standardized procedures open to the public and thus can't be included.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-MWSpec-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MWSpec_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.merriam-webster.com\/dictionary\/specification\" target=\"_blank\">\"specification\"<\/a>. <i>Merriam-Webster<\/i>. 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(2010). \"Analysis and optimization of software requirements prioritization techniques\". <i>Proceedings from the 2010 International Conference on Information and Emerging Technologies<\/i>: 1\u20136. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1109%2FICIET.2010.5625687\" target=\"_blank\">10.1109\/ICIET.2010.5625687<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Analysis+and+optimization+of+software+requirements+prioritization+techniques&rft.jtitle=Proceedings+from+the+2010+International+Conference+on+Information+and+Emerging+Technologies&rft.aulast=Aasem%2C+M.%3B+Ramzan%2C+M.%3B+Jaffar%2C+A.&rft.au=Aasem%2C+M.%3B+Ramzan%2C+M.%3B+Jaffar%2C+A.&rft.date=2010&rft.pages=1%E2%80%936&rft_id=info:doi\/10.1109%2FICIET.2010.5625687&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Hirsch10Steps13-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Hirsch10Steps13_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Hirsch, J. (22 November 2013). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering\" target=\"_blank\">\"10 Steps To Successful Requirements Gathering\"<\/a>. Phase2 Technology, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering\" target=\"_blank\">https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=10+Steps+To+Successful+Requirements+Gathering&rft.atitle=&rft.aulast=Hirsch%2C+J.&rft.au=Hirsch%2C+J.&rft.date=22+November+2013&rft.pub=Phase2+Technology%2C+LLC&rft_id=https%3A%2F%2Fwww.phase2technology.com%2Fblog%2Fsuccessful-requirements-gathering&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BurrissSoftware07-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BurrissSoftware07_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Burris, E. (2007). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">\"Requirements Specification\"<\/a>. <i>CS451R, University of Missouri\u2013Kansas City<\/i>. University of Missouri\u2013Kansas City. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">the original<\/a> on 24 July 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Requirements+Specification&rft.atitle=CS451R%2C+University+of+Missouri%E2%80%93Kansas+City&rft.aulast=Burris%2C+E.&rft.au=Burris%2C+E.&rft.date=2007&rft.pub=University+of+Missouri%E2%80%93Kansas+City&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20190724173601%2Fhttp%3A%2F%2Fsce2.umkc.edu%2FBIT%2Fburrise%2Fpl%2Frequirements%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HofmannRequire01-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HofmannRequire01_9-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Hofmann, H.F.; Lehner, F. (2001). \"Requirements engineering as a success factor in software projects\". <i>IEEE Software<\/i> <b>18<\/b> (4): 58\u201366. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1109%2FMS.2001.936219\" target=\"_blank\">10.1109\/MS.2001.936219<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Requirements+engineering+as+a+success+factor+in+software+projects&rft.jtitle=IEEE+Software&rft.aulast=Hofmann%2C+H.F.%3B+Lehner%2C+F.&rft.au=Hofmann%2C+H.F.%3B+Lehner%2C+F.&rft.date=2001&rft.volume=18&rft.issue=4&rft.pages=58%E2%80%9366&rft_id=info:doi\/10.1109%2FMS.2001.936219&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230516220749\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.451 seconds\nReal time usage: 0.750 seconds\nPreprocessor visited node count: 6296\/1000000\nPost\u2010expand include size: 137893\/2097152 bytes\nTemplate argument size: 17053\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 14712\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 130.600 1 -total\n 84.79% 110.733 1 Template:Reflist\n 62.86% 82.099 9 Template:Citation\/core\n 51.01% 66.625 7 Template:Cite_web\n 22.08% 28.830 2 Template:Cite_journal\n 15.13% 19.765 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Introduction_and_methodology\n 10.16% 13.264 6 Template:Date\n 9.86% 12.876 1 Template:LIMSpec\/Introduction_and_methodology\n 8.93% 11.657 2 Template:Citation\/identifier\n 4.78% 6.239 14 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14191-0!canonical and timestamp 20230516220750 and revision id 52016. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Introduction_and_methodology\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Introduction_and_methodology<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","00a9773130372b2ddd95ad56d5c39ac7_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/9\/9b\/Systems_Requirement_Analysis.jpg"],"00a9773130372b2ddd95ad56d5c39ac7_timestamp":1684275145,"1dd67f6027a9dc8694a017571370655a_type":"article","1dd67f6027a9dc8694a017571370655a_title":"6.1 Closing remarks","1dd67f6027a9dc8694a017571370655a_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Closing_remarks","1dd67f6027a9dc8694a017571370655a_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Closing remarksFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 6. Closing remarks \n2 Citation information for this chapter \n\n\n\n6. Closing remarks \nThe breadth of manufacturing-related industries can at times be breathtaking. From materials, metals, and machinery to food, textiles, and chemicals, most of modern society finds an intersection with their current life and a manufacturer. The Teflon on your frying pan, the steel in your car, and the Rayon in your clothing are all products of manufacturing, and many a laboratory back those manufacturers' efforts. This wasn't always the case, however, as history has shown. It wasn't until the mid- to late nineteenth century that manufacturing moved beyond the humble solo or cooperative laboratory making a handful of chemicals or pharmaceuticals (as with the apothecary of yore). The rise of the industrial research lab in the twentieth century saw manufacturing industries take off pre- and post-war, with labs acting as companions helping to ensure higher-quality recipes, as well as safer, more reliable, higher-quality products. Today, we see labs helping manufacturers achieve these goals through their roles in research and development (R&D), pre-manufacturing and manufacturing, and post-manufacturing regulatory and security operations. All of these roles inevitably highlight the demand for improved safety and quality in manufacturing facilities.\nOf course, safety and quality aren't stand-alone concepts that function in a vacuum. Demand for safety and quality influence the creation and use of standards, as do regulations that demand manufacturers focus more on that safety and quality in their workflows and outputs. Peering into the world of manufacturing standards and regulations, we find a complicated and extensive collection of recommendations and rules almost always driven by some knowledgeable consensus body both national and international. Given the numerous manufacturing-related industries, standards and regulations are numerous and often unique to the industry. This requires significant data, information, and workflow management to both ensure quality and meet regulatory guidelines. Here enters various laboratory and business informatics solutions to help give manufacturers more control over their operations, make new insights, and be as competitive as possible in an increasingly competitive manufacturing environment.\nChoosing an informatics solution like a laboratory information management system (LIMS) is no simple task, however. There are numerous considerations to make not only of the greater manufacturing industries but also the developers of applications for such industries. Increasingly important are interfaces among systems such as LIMS, manufacturing execution systems (MES), enterprise resource planning systems (ERP), product life cycle management systems (PLM), measurement instruments, and more. Some vendors even offer specialized platforms like \"materials informatics platforms\" and \"applied sciences platforms\" for manufacturers, mudding the waters further. Taking into account the wide variance in software approaches to manufacturer challenges, it's no simple task to ensure your manufacturing-related lab has what it needs to best succeed. \nThis guide has sought to help such labs better decide on their LIMS or other informatics solution. Aside from addressing all the above, this guide has also provided practical advice towards LIMS acquisition while highlighting the features broadly required by manufacturing-based labs to better do their work. Considerations concering cybersecurity, implementation, maintenance and warranty, and more have been addressed. Additional resources for finding LIMS vendors and consultants have been provided, as have sources of conferences and trade shows in various manufacturing-related industries. Additionally LIMSpec, a specification for manufacturing-related labs, is also addressed, both in passing and, at the end, in full form. Of course, a LIMS specification isn't complete without some dialogue about how best to put it to use, and Chapter 5 has addressed that. Happy LIMS hunting and acquisition!\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 6. Closing remarks\nTitle: LIMS Selection Guide for Manufacturing Quality Control\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: May 2023\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Closing_remarks\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Closing_remarks<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:07.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 3 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","1dd67f6027a9dc8694a017571370655a_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Closing_remarks rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Closing_remarks skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Closing remarks<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<div class=\"nonumtoc\">\n<\/div>\n<h2><span class=\"mw-headline\" id=\"6._Closing_remarks\">6. Closing remarks<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:KSC-20180411-PH_CSH01_0022.jpg\" class=\"image wiki-link\" data-key=\"c1cad9bf071ab248d854ab24784e4d5c\"><img alt=\"KSC-20180411-PH CSH01 0022.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/3\/33\/KSC-20180411-PH_CSH01_0022.jpg\" decoding=\"async\" width=\"350\" height=\"233\" \/><\/a><\/div><p>The breadth of manufacturing-related industries can at times be breathtaking. From materials, metals, and machinery to food, textiles, and chemicals, most of modern society finds an intersection with their current life and a manufacturer. The Teflon on your frying pan, the steel in your car, and the Rayon in your clothing are all products of manufacturing, and many a <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> back those manufacturers' efforts. This wasn't always the case, however, as history has shown. It wasn't until the mid- to late nineteenth century that manufacturing moved beyond the humble solo or cooperative laboratory making a handful of chemicals or pharmaceuticals (as with the apothecary of yore). The rise of the industrial research lab in the twentieth century saw manufacturing industries take off pre- and post-war, with labs acting as companions helping to ensure higher-quality recipes, as well as safer, more reliable, higher-quality products. Today, we see labs helping manufacturers achieve these goals through their roles in research and development (R&D), pre-manufacturing and manufacturing, and post-manufacturing regulatory and security operations. All of these roles inevitably highlight the demand for improved safety and <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_(business)\" title=\"Quality (business)\" class=\"wiki-link\" data-key=\"c4ac43430d1c3a3a15d1255257aaea37\">quality<\/a> in manufacturing facilities.\n<\/p><p>Of course, safety and quality aren't stand-alone concepts that function in a vacuum. Demand for safety and quality influence the creation and use of standards, as do regulations that demand manufacturers focus more on that safety and quality in their workflows and outputs. Peering into the world of manufacturing standards and regulations, we find a complicated and extensive collection of recommendations and rules almost always driven by some knowledgeable consensus body both national and international. Given the numerous manufacturing-related industries, standards and regulations are numerous and often unique to the industry. This requires significant data, information, and workflow management to both ensure quality and meet <a href=\"https:\/\/www.limswiki.org\/index.php\/Regulatory_compliance\" title=\"Regulatory compliance\" class=\"wiki-link\" data-key=\"7dbc9be278a8efda25a4b592ee6ef0ca\">regulatory guidelines<\/a>. Here enters various <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory<\/a> and business informatics solutions to help give manufacturers more control over their operations, make new insights, and be as competitive as possible in an increasingly competitive manufacturing environment.\n<\/p><p>Choosing an informatics solution like a <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS) is no simple task, however. There are numerous considerations to make not only of the greater manufacturing industries but also the developers of applications for such industries. Increasingly important are interfaces among systems such as LIMS, <a href=\"https:\/\/www.limswiki.org\/index.php\/Manufacturing_execution_system\" title=\"Manufacturing execution system\" class=\"wiki-link\" data-key=\"02e93282eda3e4708b1789cb47519917\">manufacturing execution systems<\/a> (MES), <a href=\"https:\/\/www.limswiki.org\/index.php\/Enterprise_resource_planning\" title=\"Enterprise resource planning\" class=\"wiki-link\" data-key=\"07be791b94a208f794e38224f0c0950b\">enterprise resource planning<\/a> systems (ERP), product life cycle management systems (PLM), measurement instruments, and more. Some vendors even offer specialized platforms like \"materials informatics platforms\" and \"applied sciences platforms\" for manufacturers, mudding the waters further. Taking into account the wide variance in software approaches to manufacturer challenges, it's no simple task to ensure your manufacturing-related lab has what it needs to best succeed. \n<\/p><p>This guide has sought to help such labs better decide on their LIMS or other informatics solution. Aside from addressing all the above, this guide has also provided practical advice towards LIMS acquisition while highlighting the features broadly required by manufacturing-based labs to better do their work. Considerations concering <a href=\"https:\/\/www.limswiki.org\/index.php\/Cybersecurity\" class=\"mw-redirect wiki-link\" title=\"Cybersecurity\" data-key=\"ba653dc2a1384e5f9f6ac9dc1a740109\">cybersecurity<\/a>, implementation, maintenance and warranty, and more have been addressed. Additional resources for finding LIMS vendors and consultants have been provided, as have sources of conferences and trade shows in various manufacturing-related industries. Additionally LIMSpec, a specification for manufacturing-related labs, is also addressed, both in passing and, at the end, in full form. Of course, a LIMS specification isn't complete without some dialogue about how best to put it to use, and Chapter 5 has addressed that. Happy LIMS hunting and acquisition!\n<\/p><p><br \/>\n<\/p>\n<div align=\"center\">-----Go to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Introduction_and_methodology\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Introduction and methodology\" class=\"wiki-link\" data-key=\"00a9773130372b2ddd95ad56d5c39ac7\">the next chapter<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: 6. Closing remarks\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for Manufacturing Quality Control<\/i>\n<\/p><p><b>Edition<\/b>: First Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: May 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230516221038\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.040 seconds\nReal time usage: 0.052 seconds\nPreprocessor visited node count: 13\/1000000\nPost\u2010expand include size: 4243\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 3\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 8.654 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Closing_remarks\n100.00% 8.654 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14190-0!canonical and timestamp 20230516221038 and revision id 52015. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Closing_remarks\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Closing_remarks<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","1dd67f6027a9dc8694a017571370655a_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/3\/33\/KSC-20180411-PH_CSH01_0022.jpg"],"1dd67f6027a9dc8694a017571370655a_timestamp":1684275144,"46a8688154033c3e5f25ef709d80d41e_type":"article","46a8688154033c3e5f25ef709d80d41e_title":"5.4 Finalize the requirements specification and choose a vendor","46a8688154033c3e5f25ef709d80d41e_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor","46a8688154033c3e5f25ef709d80d41e_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Taking the next step\/Finalize the requirements specification and choose a vendorFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n5.4 Finalize the requirements specification and choose a vendor \nNow that the demonstrations have been conducted and more questions asked, you should be close to finalizing your requirement specifications with one ore more vendors. In fact, you may have taken LIMSpec, chosen a few critical requirements from it, added them to a few unique requirements of your own, and included them as part of an RFI or question and answer session with vendors. You then likely took those responses and added them to your wider overall specification (e.g., LIMSpec), along with your own notes and observations from interacting with the vendor. This may have been repeated for several vendors and their offerings. \nAt this point, you're likely ready to either have those vendors complete the rest of the responses for their corresponding URS, or you may even be ready to narrow down your vendor selection. This all likely depends on what the initial fact finding revealed. How well did the vendors respond to your laboratory's unique set of needs? Were there critical areas that one vendor could address with their off-the-shelf solution but another vendor would have to address with custom coding? Did any of the vendors meet your budget expectations? Have you followed up on any references and customer experiences the vendors provided to you? \nIt may be that several vendors are appealing at this point, meaning it's time to have them respond to the rest of the URS. This makes not only for good due diligence, to better ensure most requirements can be met, but also a reviewable option for any \"tie-breaker\" you have between vendors. In reality, this tie-breaker scenario would rarely come up; more often, some other aspect of the software, company, or pricing will be a stronger limiter. However, you still want to get all those vendor responses, even if you've early on filtered your options down to one vendor.\nUltimately, your specification document may look similar to the LIMSpec, or it may have a slightly different format. Many prospective buyers will develop a requirement specification in Microsoft Excel, but that has a few minor disadvantages. Regardless of format, you'll want to give plenty of space for vendors to submit a response to each requirement. For your convenience, a Microsoft Word version of Appendix 1's LIMSpec for manufacturing labs is also included as part of this guide (see A8. LIMSpec in Microsoft Word format). That document is editable, giving end users and vendors the flexibility to remove information and enlarge columns. \nAdditionally, remember that often is the case that after the URS is completed and final questions asked, no single vendor can meet all your needs. Be ready for this possibility, whether it be a functionality requirement or a budget issue. Know ahead of time where your laboratory is willing to be flexible, and how much flex you have. After all of your lab's preparation, and with a little luck, you've found a vendor that fits the bill, even if a few minor compromises had to be made along the way.\n\nReferences \n\n\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 5. Taking the next step\nTitle: LIMS Selection Guide for Manufacturing Quality Control\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: May 2023\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:06.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","46a8688154033c3e5f25ef709d80d41e_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Taking_the_next_step_Finalize_the_requirements_specification_and_choose_a_vendor rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Taking_the_next_step_Finalize_the_requirements_specification_and_choose_a_vendor skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Taking the next step\/Finalize the requirements specification and choose a vendor<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"5.4_Finalize_the_requirements_specification_and_choose_a_vendor\">5.4 Finalize the requirements specification and choose a vendor<\/span><\/h3>\n<p>Now that the demonstrations have been conducted and more questions asked, you should be close to finalizing your requirement specifications with one ore more vendors. In fact, you may have taken LIMSpec, chosen a few critical requirements from it, added them to a few unique requirements of your own, and included them as part of an RFI or question and answer session with vendors. You then likely took those responses and added them to your wider overall specification (e.g., LIMSpec), along with your own notes and observations from interacting with the vendor. This may have been repeated for several vendors and their offerings. \n<\/p><p>At this point, you're likely ready to either have those vendors complete the rest of the responses for their corresponding URS, or you may even be ready to narrow down your vendor selection. This all likely depends on what the initial fact finding revealed. How well did the vendors respond to your laboratory's unique set of needs? Were there critical areas that one vendor could address with their off-the-shelf solution but another vendor would have to address with custom coding? Did any of the vendors meet your budget expectations? Have you followed up on any references and customer experiences the vendors provided to you? \n<\/p><p>It may be that several vendors are appealing at this point, meaning it's time to have them respond to the rest of the URS. This makes not only for good due diligence, to better ensure most requirements can be met, but also a reviewable option for any \"tie-breaker\" you have between vendors. In reality, this tie-breaker scenario would rarely come up; more often, some other aspect of the software, company, or pricing will be a stronger limiter. However, you still want to get all those vendor responses, even if you've early on filtered your options down to one vendor.\n<\/p><p>Ultimately, your specification document may look similar to the LIMSpec, or it may have a slightly different format. Many prospective buyers will develop a requirement specification in Microsoft Excel, but that has a few minor disadvantages. Regardless of format, you'll want to give plenty of space for vendors to submit a response to each requirement. For your convenience, a Microsoft Word version of Appendix 1's LIMSpec for manufacturing labs is also included as part of this guide (see A8. LIMSpec in Microsoft Word format). That document is editable, giving end users and vendors the flexibility to remove information and enlarge columns. \n<\/p><p>Additionally, remember that often is the case that after the URS is completed and final questions asked, no single vendor can meet all your needs. Be ready for this possibility, whether it be a functionality requirement or a budget issue. Know ahead of time where your laboratory is willing to be flexible, and how much flex you have. After all of your lab's preparation, and with a little luck, you've found a vendor that fits the bill, even if a few minor compromises had to be made along the way.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<\/div>\n<p><br \/>\n<\/p>\n<div align=\"center\">-----Go to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Closing_remarks\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Closing remarks\" class=\"wiki-link\" data-key=\"1dd67f6027a9dc8694a017571370655a\">the next chapter<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: 5. Taking the next step\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for Manufacturing Quality Control<\/i>\n<\/p><p><b>Edition<\/b>: First Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: May 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230516221224\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.015 seconds\nReal time usage: 0.021 seconds\nPreprocessor visited node count: 57\/1000000\nPost\u2010expand include size: 3584\/2097152 bytes\nTemplate argument size: 24\/2097152 bytes\nHighest expansion depth: 7\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 14.417 1 -total\n 60.71% 8.753 1 Template:Reflist\n 38.22% 5.510 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor\n 27.11% 3.909 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14189-0!canonical and timestamp 20230516221224 and revision id 52013. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","46a8688154033c3e5f25ef709d80d41e_images":[],"46a8688154033c3e5f25ef709d80d41e_timestamp":1684275144,"dc2dde21cc8a46ea3112996c30b06df7_type":"article","dc2dde21cc8a46ea3112996c30b06df7_title":"5.3 Respond to or open dialogue with vendors","dc2dde21cc8a46ea3112996c30b06df7_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors","dc2dde21cc8a46ea3112996c30b06df7_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Taking the next step\/Respond to or open dialogue with vendorsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n5.3 Respond to or open dialogue with vendors \nIf you went the route of the RFI, you hopefully received more than a few well-crafted responses. Your RFI presumably included a small but critical set of requirements that needed to be addressed, and the vendors who responded dutifully addressed those critical requirements. Even if you didn't send out an RFI, you at least did your own research about some of the big players in the laboratory informatics space, and you may have even opened an initial dialogue with a few of them. If all has gone well, you're now at the point where you've narrowed down the pool of vendors but still have a basket of them to continue dialogue with. (If you're not comfortably at this point after an RFI or engagements with multiple vendors, you may need to either reconsider the effectiveness of your RFI or engagements or enlist help from a knowledgeable and experienced consultant to help steer you back on-course.)\nAs dialogue continues with vendors, you'll have several points to address:\n1. What do I want their laboratory information management system (LIMS) to do for me?\n2. How does their solution fit into our previously discussed budget?\nRegarding question one, you've already laid some of the groundwork for that with the help of your handful of critical requirements (and the associated research that went into developing them). Outside of those critical requirements, a laboratory informatics solution should also provide clearly definable benefits to how you operate your manufacturing laboratory. These expected benefits should tie in with your overall business mission and goals. Using a LIMS as an example, here are a few of the benefits a well-developed LIMS can provide to practically any laboratory. Whenever you go through the discovery process with a vendor, you'll be asking how their system provides these and other benefits through its functionality. A quality LIMS can provide[1][2]:\n\nincreased accuracy: the minimization or elimination of transcription and other errors;\nstreamlined processes: ensuring each process step in a protocol\/method is completed in the proper order, with all requirements met, updating sample statuses automatically;\nautomation: integration with instruments, allowing for automatic uploading of samples and returning of results;\nregulatory and standards compliance: functionality that aids with compliance, including reporting results to state and local authorities;\ndata security: role-based, configurable, secure access to data, processes, reporting, etc.;\nflexible reporting: reporting tools that allows for the design and generation of certificates of authority and other reports to lab- and regulation-based specs;\ninstant data retrieval: query tools for finding data instantly according to any criteria (date range, test, product type, etc.); and\nconfigurability and cost-effectiveness: a user-configurable system (as opposed to hard-coded, requiring development for any modifications) that is flexible enough to adapt to rapid changes in test volume and type over time, without breaking the bank.\nAs for the second question, budgeting is always a tricky topic, both internally and when discussing it with vendors. We already mentioned in the previous section that addressing the acquisition and long-term maintenance budget of your solution(s) must be addressed as part of your lab's business considerations. (And we already mentioned some cost considerations in 3.1.6; this discussion will add a few more points.) The fact that laboratory informatics systems like the LIMS come in all kinds of price ranges makes it difficult to judge if a given system, as priced, is appropriate for your lab and its budget. There are some basic cost realities associated with LIMS acquisition[3][4], which will help you understand where the vendor price comes from, and how it figures into your lab's budget (though some of these concepts may also apply to other informatics systems).\n\n1. Vendor pricing is generally based on how many will be using the system. This can be measured in concurrent users (how many will be using the system at any one time) or named users (the number of total users who will ever use the system, by name). Additionally, laboratory informatics vendors increasingly offer the option of a cloud-hosted subscription, which of course has the advantage of not requiring your own IT department, and allowing labs to defray cost over time, with little or no actual license fee. Think about your usage strategy and choose the pricing format that makes the most sense for you.\n2. Most costs are related to the work involved with installing, configuring, and migrating data to the system. Try to choose a solution that has what you need out of the box, as much as possible. The more customized or unique options you ask for up-front, the more it tends to cost, as extra items are a function of the time it takes developers to add them.\n3. \"User-configurable\" beats \"vendor-configurable\" on cost-effectiveness. Some vendors offer a free or low-cost option, but don't be fooled. They are in business to make money, and they are counting on the fact that you'll need to pay them to make things work, add necessary functionality, and provide support and training. If you can find a vendor who offers a genuinely user-configurable system, and whose manuals and other support materials are clearly helpful and available so that you can adjust things the way you want, when you want, then that will go a long way toward budget efficiency and longevity.\n4. Additional interfaces and reporting requirements cost money. If necessary, consider phasing in any additional instrument and software interfaces over time, as revenue eases cash flow. You can go live with your system operations more quickly, entering results manually until you can afford to interface your instruments one-by-one. This goes for reports as well; a simple reporting module that meets regulatory requirements will do. You can make your reports and other exportable documents more attractive later.\nIdeally, your budget has room for roughly $40- to $80,000 minimum (including setup, training, interfaces, etc.) for a quality, full-featured professional LIMS or LIS, with $300 to $900 per month (depending on number of users) for ongoing subscriptions. At around five concurrent users, the economics start to favor purchasing perpetual licenses rather than paying for a subscription. Purchased licenses will also entail ongoing annual or monthly costs as well (e.g., maintenance, support, warranty for updates etc.) Subscriptions (if available) are generally aimed at smaller labs. If you will be growing and scaling up, it may be a great way to get started, but make sure you have the option to switch to perpetual licenses later. \nWith much of this information in hand, you're likely ready to move on to finalizing the requirements specification and choosing a vendor, but not before you've sat through a few highly useful demonstrations.\n\n5.3.1 The value of demonstrations \nA demonstration of laboratory informatics solution is an integral part of making your final decisions. The demo offers a unique and valuable opportunity to see in-person how data and information is added, edited, deleted, tracked, and protected within the context of the application; you can ask about how a function works and see it right then and there. Equally, it is an excellent time to compare notes with the vendor, particularly in regard to the critical requirement that were addressed in your RFI (or through direct communication with the vendor). You can ask the vendor in real-time to answer questions about how a specific task is achieved, and the vendor can ask you about your lab's system and workflow requirements and how you best envision them being implemented in the system (e.g., does this interface seem intuitive?).\nA demonstration is typically performed online, which is useful for a couple of reasons, COVID-19 notwithstanding. First, it means you can schedule and reschedule at your convenience, with little in the way of logistics to arrange. Second, the demonstration session is likely to be recorded (verify this), so everyone is clear on what was promised and what wasn't, how processes were shown to work, etc. Additionally, you can later review parts you may have missed, forgotten, or not quite understood, and you can share it with others, who then also get a look at the proposed system in action.\nBe careful about falling for the temptation of presenting a full URS or other specification document to the vendor during the demonstration. You'll want to wait until after participating in several software demonstrations to consider presenting your full specification document to the vendor, and that's assuming that you've grown enamored with their solution. By waiting to finalize your lab's requirements specification until after the demos, a common error is avoided: too often labs think the first thing they must do is create a requirements list, then sit back and let the informatics vendors tell them how they meet it. Remember that even though most labs thoroughly understand their processes, they likely don't have as strong a grasp on the informatics portion of their processes and workflows. Participating in a demo before finalizing your list of specified requirements\u2014or having only a minimal yet flexible requirements list during the demo\u2014is a great way to later crosscheck the software features you have seen demonstrated to your lab's processes and any initial requirements specification you've made.[5] After all, how can you effectively require specific manufacturing-related functions of your laboratory informatics software if you don't fully know what such an industry-specific system is capable of? After the demonstrations, you may end up adding several requirements to your final specifications document, which you later pass on to your potential vendors of choice for final confirmation.\n\nReferences \n\n\n\u2191 McLelland, A. (1998). \"What is a LIMS - a laboratory toy, or a critical IT component?\" (PDF). Royal Society of Chemistry. p. 1. Archived from the original on 04 October 2013. https:\/\/web.archive.org\/web\/20131004232754\/http:\/\/www.rsc.org\/pdf\/andiv\/tech.pdf . Retrieved 07 December 2022 .   \n \n\n\u2191 Joyce, J.R. (2010). \"Industry Insights: Examining the Risks, Benefits and Trade-offs of Today\u2019s LIMS\". Scientific Computing (January\/February 2010): 15\u201323.   \n \n\n\u2191 Rosenberg, H.J. (28 March 2017). \"How Much Does a LIMS Cost? Licensing and Beyond\". SlideShare. https:\/\/www.slideshare.net\/CSolsInc\/how-much-does-a-lims-cost-licensing-and-beyond-pittcon-2017-tech-talk . Retrieved 07 December 2022 .   \n \n\n\u2191 \"Saving Costs with LIMS\". CSols, Inc. 25 October 2018. https:\/\/www.csolsinc.com\/blog\/saving-costs-with-lims\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 Hammer, S. (27 June 2019). \"How to Get the Most Value from an ERP Software Demo\". The Takeoff. https:\/\/www.striven.com\/blog\/erp-software-demo . Retrieved 07 December 2022 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:02.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed once.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","dc2dde21cc8a46ea3112996c30b06df7_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Taking_the_next_step_Respond_to_or_open_dialogue_with_vendors rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Taking_the_next_step_Respond_to_or_open_dialogue_with_vendors skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Taking the next step\/Respond to or open dialogue with vendors<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"5.3_Respond_to_or_open_dialogue_with_vendors\">5.3 Respond to or open dialogue with vendors<\/span><\/h3>\n<p>If you went the route of the RFI, you hopefully received more than a few well-crafted responses. Your RFI presumably included a small but critical set of requirements that needed to be addressed, and the vendors who responded dutifully addressed those critical requirements. Even if you didn't send out an RFI, you at least did your own research about some of the big players in the laboratory informatics space, and you may have even opened an initial dialogue with a few of them. If all has gone well, you're now at the point where you've narrowed down the pool of vendors but still have a basket of them to continue dialogue with. (If you're not comfortably at this point after an RFI or engagements with multiple vendors, you may need to either reconsider the effectiveness of your RFI or engagements or enlist help from a knowledgeable and experienced consultant to help steer you back on-course.)\n<\/p><p>As dialogue continues with vendors, you'll have several points to address:\n<\/p><p>1. What do I want their <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS) to do for me?\n<\/p><p>2. How does their solution fit into our previously discussed budget?\n<\/p><p>Regarding question one, you've already laid some of the groundwork for that with the help of your handful of critical requirements (and the associated research that went into developing them). Outside of those critical requirements, a laboratory informatics solution should also provide clearly definable benefits to how you operate your manufacturing laboratory. These expected benefits should tie in with your overall business mission and goals. Using a LIMS as an example, here are a few of the benefits a well-developed LIMS can provide to practically any laboratory. Whenever you go through the discovery process with a vendor, you'll be asking how their system provides these and other benefits through its functionality. A quality LIMS can provide<sup id=\"rdp-ebb-cite_ref-McLelland98_1-0\" class=\"reference\"><a href=\"#cite_note-McLelland98-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SciCompRisksBens_2-0\" class=\"reference\"><a href=\"#cite_note-SciCompRisksBens-2\">[2]<\/a><\/sup>:\n<\/p>\n<ul><li>increased accuracy: the minimization or elimination of transcription and other errors;<\/li>\n<li>streamlined processes: ensuring each process step in a protocol\/method is completed in the proper order, with all requirements met, updating sample statuses automatically;<\/li>\n<li>automation: integration with instruments, allowing for automatic uploading of samples and returning of results;<\/li>\n<li>regulatory and standards compliance: functionality that aids with compliance, including reporting results to state and local authorities;<\/li>\n<li>data security: role-based, configurable, secure access to data, processes, reporting, etc.;<\/li>\n<li>flexible reporting: reporting tools that allows for the design and generation of certificates of authority and other reports to lab- and regulation-based specs;<\/li>\n<li>instant data retrieval: query tools for finding data instantly according to any criteria (date range, test, product type, etc.); and<\/li>\n<li>configurability and cost-effectiveness: a user-configurable system (as opposed to hard-coded, requiring development for any modifications) that is flexible enough to adapt to rapid changes in test volume and type over time, without breaking the bank.<\/li><\/ul>\n<p>As for the second question, budgeting is always a tricky topic, both internally and when discussing it with vendors. We already mentioned in the previous section that addressing the acquisition and long-term maintenance budget of your solution(s) must be addressed as part of your lab's business considerations. (And we already mentioned some cost considerations in 3.1.6; this discussion will add a few more points.) The fact that laboratory informatics systems like the LIMS come in all kinds of price ranges makes it difficult to judge if a given system, as priced, is appropriate for your lab and its budget. There are some basic cost realities associated with LIMS acquisition<sup id=\"rdp-ebb-cite_ref-CSolsHowMuch17_3-0\" class=\"reference\"><a href=\"#cite_note-CSolsHowMuch17-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CSolsSaving18_4-0\" class=\"reference\"><a href=\"#cite_note-CSolsSaving18-4\">[4]<\/a><\/sup>, which will help you understand where the vendor price comes from, and how it figures into your lab's budget (though some of these concepts may also apply to other informatics systems).\n<\/p>\n<dl><dd>1. Vendor pricing is generally based on how many will be using the system. This can be measured in concurrent users (how many will be using the system at any one time) or named users (the number of total users who will ever use the system, by name). Additionally, laboratory informatics vendors increasingly offer the option of a <a href=\"https:\/\/www.limswiki.org\/index.php\/Cloud_computing\" title=\"Cloud computing\" class=\"wiki-link\" data-key=\"fcfe5882eaa018d920cedb88398b604f\">cloud-hosted<\/a> subscription, which of course has the advantage of not requiring your own IT department, and allowing labs to defray cost over time, with little or no actual license fee. Think about your usage strategy and choose the pricing format that makes the most sense for you.<\/dd><\/dl>\n<dl><dd>2. Most costs are related to the work involved with installing, configuring, and migrating data to the system. Try to choose a solution that has what you need out of the box, as much as possible. The more customized or unique options you ask for up-front, the more it tends to cost, as extra items are a function of the time it takes developers to add them.<\/dd><\/dl>\n<dl><dd>3. \"User-configurable\" beats \"vendor-configurable\" on cost-effectiveness. Some vendors offer a free or low-cost option, but don't be fooled. They are in business to make money, and they are counting on the fact that you'll need to pay them to make things work, add necessary functionality, and provide support and training. If you can find a vendor who offers a genuinely user-configurable system, and whose manuals and other support materials are clearly helpful and available so that you can adjust things the way you want, when you want, then that will go a long way toward budget efficiency and longevity.<\/dd><\/dl>\n<dl><dd>4. Additional interfaces and reporting requirements cost money. If necessary, consider phasing in any additional instrument and software interfaces over time, as revenue eases cash flow. You can go live with your system operations more quickly, entering results manually until you can afford to interface your instruments one-by-one. This goes for reports as well; a simple reporting module that meets regulatory requirements will do. You can make your reports and other exportable documents more attractive later.<\/dd><\/dl>\n<p>Ideally, your budget has room for roughly $40- to $80,000 minimum (including setup, training, interfaces, etc.) for a quality, full-featured professional LIMS or LIS, with $300 to $900 per month (depending on number of users) for ongoing subscriptions. At around five concurrent users, the economics start to favor purchasing perpetual licenses rather than paying for a subscription. Purchased licenses will also entail ongoing annual or monthly costs as well (e.g., maintenance, support, warranty for updates etc.) Subscriptions (if available) are generally aimed at smaller labs. If you will be growing and scaling up, it may be a great way to get started, but make sure you have the option to switch to perpetual licenses later. \n<\/p><p>With much of this information in hand, you're likely ready to move on to finalizing the requirements specification and choosing a vendor, but not before you've sat through a few highly useful demonstrations.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"5.3.1_The_value_of_demonstrations\">5.3.1 The value of demonstrations<\/span><\/h4>\n<div class=\"floatleft\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:ForUM_demo_(2659615090).jpg\" class=\"image wiki-link\" data-key=\"6d24fe10a7ea5ad2ee42e7e70cca00b6\"><img alt=\"ForUM demo (2659615090).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/55\/ForUM_demo_%282659615090%29.jpg\" decoding=\"async\" width=\"360\" height=\"270\" \/><\/a><\/div><p>A demonstration of laboratory informatics solution is an integral part of making your final decisions. The demo offers a unique and valuable opportunity to see in-person how data and information is added, edited, deleted, tracked, and protected within the context of the application; you can ask about how a function works and see it right then and there. Equally, it is an excellent time to compare notes with the vendor, particularly in regard to the critical requirement that were addressed in your RFI (or through direct communication with the vendor). You can ask the vendor in real-time to answer questions about how a specific task is achieved, and the vendor can ask you about your lab's system and workflow requirements and how you best envision them being implemented in the system (e.g., does this interface seem intuitive?).\n<\/p><p>A demonstration is typically performed online, which is useful for a couple of reasons, COVID-19 notwithstanding. First, it means you can schedule and reschedule at your convenience, with little in the way of logistics to arrange. Second, the demonstration session is likely to be recorded (verify this), so everyone is clear on what was promised and what wasn't, how processes were shown to work, etc. Additionally, you can later review parts you may have missed, forgotten, or not quite understood, and you can share it with others, who then also get a look at the proposed system in action.\n<\/p><p>Be careful about falling for the temptation of presenting a full URS or other specification document to the vendor during the demonstration. You'll want to wait until after participating in several software demonstrations to consider presenting your full specification document to the vendor, and that's assuming that you've grown enamored with their solution. By waiting to finalize your lab's requirements specification until after the demos, a common error is avoided: too often labs think the first thing they must do is create a requirements list, then sit back and let the informatics vendors tell them how they meet it. Remember that even though most labs thoroughly understand their processes, they likely don't have as strong a grasp on the informatics portion of their processes and workflows. Participating in a demo before finalizing your list of specified requirements\u2014or having only a minimal yet flexible requirements list during the demo\u2014is a great way to later crosscheck the software features you have seen demonstrated to your lab's processes and any initial requirements specification you've made.<sup id=\"rdp-ebb-cite_ref-HammerHowTo19_5-0\" class=\"reference\"><a href=\"#cite_note-HammerHowTo19-5\">[5]<\/a><\/sup> After all, how can you effectively require specific manufacturing-related functions of your laboratory informatics software if you don't fully know what such an industry-specific system is capable of? After the demonstrations, you may end up adding several requirements to your final specifications document, which you later pass on to your potential vendors of choice for final confirmation.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-McLelland98-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-McLelland98_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">McLelland, A. (1998). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20131004232754\/http:\/\/www.rsc.org\/pdf\/andiv\/tech.pdf\" target=\"_blank\">\"What is a LIMS - a laboratory toy, or a critical IT component?\"<\/a> (PDF). Royal Society of Chemistry. p. 1. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.rsc.org\/pdf\/andiv\/tech.pdf\" target=\"_blank\">the original<\/a> on 04 October 2013<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20131004232754\/http:\/\/www.rsc.org\/pdf\/andiv\/tech.pdf\" target=\"_blank\">https:\/\/web.archive.org\/web\/20131004232754\/http:\/\/www.rsc.org\/pdf\/andiv\/tech.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=What+is+a+LIMS+-+a+laboratory+toy%2C+or+a+critical+IT+component%3F&rft.atitle=&rft.aulast=McLelland%2C+A.&rft.au=McLelland%2C+A.&rft.date=1998&rft.pages=p.+1&rft.pub=Royal+Society+of+Chemistry&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20131004232754%2Fhttp%3A%2F%2Fwww.rsc.org%2Fpdf%2Fandiv%2Ftech.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SciCompRisksBens-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SciCompRisksBens_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Joyce, J.R. (2010). \"Industry Insights: Examining the Risks, Benefits and Trade-offs of Today\u2019s LIMS\". <i>Scientific Computing<\/i> (January\/February 2010): 15\u201323.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Industry+Insights%3A+Examining+the+Risks%2C+Benefits+and+Trade-offs+of+Today%E2%80%99s+LIMS&rft.jtitle=Scientific+Computing&rft.aulast=Joyce%2C+J.R.&rft.au=Joyce%2C+J.R.&rft.date=2010&rft.issue=January%2FFebruary+2010&rft.pages=15%E2%80%9323&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CSolsHowMuch17-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CSolsHowMuch17_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Rosenberg, H.J. (28 March 2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.slideshare.net\/CSolsInc\/how-much-does-a-lims-cost-licensing-and-beyond-pittcon-2017-tech-talk\" target=\"_blank\">\"How Much Does a LIMS Cost? Licensing and Beyond\"<\/a>. <i>SlideShare<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.slideshare.net\/CSolsInc\/how-much-does-a-lims-cost-licensing-and-beyond-pittcon-2017-tech-talk\" target=\"_blank\">https:\/\/www.slideshare.net\/CSolsInc\/how-much-does-a-lims-cost-licensing-and-beyond-pittcon-2017-tech-talk<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+Much+Does+a+LIMS+Cost%3F+Licensing+and+Beyond&rft.atitle=SlideShare&rft.aulast=Rosenberg%2C+H.J.&rft.au=Rosenberg%2C+H.J.&rft.date=28+March+2017&rft_id=https%3A%2F%2Fwww.slideshare.net%2FCSolsInc%2Fhow-much-does-a-lims-cost-licensing-and-beyond-pittcon-2017-tech-talk&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CSolsSaving18-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CSolsSaving18_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.csolsinc.com\/blog\/saving-costs-with-lims\/\" target=\"_blank\">\"Saving Costs with LIMS\"<\/a>. CSols, Inc. 25 October 2018<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.csolsinc.com\/blog\/saving-costs-with-lims\/\" target=\"_blank\">https:\/\/www.csolsinc.com\/blog\/saving-costs-with-lims\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Saving+Costs+with+LIMS&rft.atitle=&rft.date=25+October+2018&rft.pub=CSols%2C+Inc&rft_id=https%3A%2F%2Fwww.csolsinc.com%2Fblog%2Fsaving-costs-with-lims%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HammerHowTo19-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HammerHowTo19_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Hammer, S. (27 June 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.striven.com\/blog\/erp-software-demo\" target=\"_blank\">\"How to Get the Most Value from an ERP Software Demo\"<\/a>. <i>The Takeoff<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.striven.com\/blog\/erp-software-demo\" target=\"_blank\">https:\/\/www.striven.com\/blog\/erp-software-demo<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+to+Get+the+Most+Value+from+an+ERP+Software+Demo&rft.atitle=The+Takeoff&rft.aulast=Hammer%2C+S.&rft.au=Hammer%2C+S.&rft.date=27+June+2019&rft_id=https%3A%2F%2Fwww.striven.com%2Fblog%2Ferp-software-demo&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230516220233\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.083 seconds\nReal time usage: 0.098 seconds\nPreprocessor visited node count: 3539\/1000000\nPost\u2010expand include size: 32041\/2097152 bytes\nTemplate argument size: 8276\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 7364\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 79.887 1 -total\n 86.10% 68.783 1 Template:Reflist\n 58.24% 46.528 4 Template:Cite_web\n 56.68% 45.279 5 Template:Citation\/core\n 14.12% 11.282 4 Template:Date\n 13.79% 11.015 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\n 12.45% 9.948 1 Template:Cite_journal\n 5.69% 4.547 8 Template:Citation\/make_link\n 3.54% 2.825 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14188-0!canonical and timestamp 20230516220234 and revision id 52012. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","dc2dde21cc8a46ea3112996c30b06df7_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/55\/ForUM_demo_%282659615090%29.jpg"],"dc2dde21cc8a46ea3112996c30b06df7_timestamp":1684275144,"33d82d5dd5f85fea7ef356a3cc2dbbf0_type":"article","33d82d5dd5f85fea7ef356a3cc2dbbf0_title":"5.2 Issue some of the specification as part of a request for information (RFI)","33d82d5dd5f85fea7ef356a3cc2dbbf0_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)","33d82d5dd5f85fea7ef356a3cc2dbbf0_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Taking the next step\/Issue some of the specification as part of a request for information (RFI)From LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n 5.2 Issue some of the specification as part of a request for information (RFI) \nIn some cases\u2014particularly if your organization is of significant size\u2014it may make sense to issue a formal RFI or request for proposal (RFP) and have laboratory informatics vendors approach your lab with how they can meet its needs. The RFI and RFP are traditional means towards soliciting bidding interest in an organization's project, containing the organization's specific requirements and vital questions that the bidder should be able to effectively answer. However, even if your organization chooses to skip the RFI or RFP process and do most of the investigative work of researching and approaching informatics vendors, turning to a key set of questions typically found in an RFI is extremely valuable towards your fact finding.\nAn RFI is an ideal means for learning more about a potential solution and how it can solve your problems, or for when you're not even sure how to solve your problem yet. However, the RFI should not be unduly long and tedious to complete for prospective vendors; it should be concise, direct, and honest. This means not only presenting a clear and humble vision of your own organization and its goals, but also asking just the right amount of questions to allow potential vendors to demonstrate their expertise and provide a clearer picture of who they are. Some take a technical approach to an RFI, using dense language and complicated spreadsheets for fact finding. However, as previously noted, you will want to limit the specified requirements in your RFI to those carefully chosen because they matter to you and your lab the most.[1] \nRemember, an RFI is not meant to answer all of your questions. The RFI is meant as a means to help narrow down your search to a few quality candidates while learning more about each other.[1] Once the pool of potential software vendors is narrowed down, and you then participate in their demonstrations, you then can broadly add more requirements to the original collection of critical requirements from the RFI to ensure those providers meet all or most of your needs. That said, be cognizant that there may be no vendor that can meet each and every need of your lab. Your lab will have to make important decisions about which requirements are non-negotiable and which are more flexible. The vendors you engage with may be able to provide realistic advice in this regard, based upon your lab's requirements and their past experience with labs. As such, those vendors with real-world experience meeting the needs of manufacturing laboratories may have a strong leg up on other vendors.\nAgain, Appendix 1 of this guide includes a comprehensive specifications document called LIMSpec, from which you can draw the requirements that are most critical to be addressed in an RFI. If you have zero experience developing an RFI, you may want to first seek out various example RFIs on the internet, as well as some basic advice articles on the topic. Some websites may provide templates to examine for further details. Broadly speaking, if you're conducting a full RFI or RFP, you're going to lead with the standard components of an RFI or RFP, including:\n\na table of contents;\nan honest introduction and overview of your organization, its goals and problems, and the services sought to solve them;\ndetails on how the RFI or RFP evaluation process will be conducted;\nbasis for award (if an RFP);\nthe calendar schedule (including times) for related events;\nhow to submit the document and any related questions about it, including response format; and\nyour organization's background, business requirements, and current technical environment.\nBeing honest about your organization, its informatics requirements, and its current technical environment upfront in the RFI or RFP will also ensure that the time spent on the process is optimized for all involved parties. Before submitting any RFI, your lab will want to conduct thorough internal research ensuring everyone understands what the current technology and processes are, and how you all want to shape that with the introduction or updating of laboratory informatics systems. (If your lab has limited to no experience with adding automation and informatics elements to a laboratory, you may want to read through laboratory informatics veteran Joe Liscouski's The Application of Informatics to Scientific Work: Laboratory Informatics for Newbies for further insight.) You'll also want to answer critical questions such as \"who will be responsible for maintaining the solution and its security?\" and \"how will our processes and procedures change with the introduction or updating of informatics systems?\". These and other questions make up your business considerations, which should also address the:\n\nacquisition and long-term maintenance budget;\ndiversity of laboratory services offered now and into the future;\nlevel of in-house knowledge and experience with informatics systems and automation;\nlevel of in-house, executive buy-in of informatics adoption; and\nneed for additional vendor pre-planning.\nOne other note: make it clear in any issued RFI that it's strictly a request for information and not a guarantee to issue a contract with any respondent.\n\nReferences \n\n\n\u2191 1.0 1.1 Holmes, T.. \"It's a Match: How to Run a Good RFI, RFP, or RFQ and Find the Right Partner\". AllCloud Blog. https:\/\/allcloud.io\/blog\/its-a-match-how-to-run-a-good-rfi-rfp-or-rfq-and-find-the-right-partner\/ . Retrieved 07 December 2022 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:02.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","33d82d5dd5f85fea7ef356a3cc2dbbf0_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Taking_the_next_step_Issue_some_of_the_specification_as_part_of_a_request_for_information_RFI rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Taking_the_next_step_Issue_some_of_the_specification_as_part_of_a_request_for_information_RFI skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Taking the next step\/Issue some of the specification as part of a request for information (RFI)<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<h3><span id=\"rdp-ebb-5.2_Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\"><\/span><span class=\"mw-headline\" id=\"5.2_Issue_some_of_the_specification_as_part_of_a_request_for_information_.28RFI.29\">5.2 Issue some of the specification as part of a request for information (RFI)<\/span><\/h3>\n<p>In some cases\u2014particularly if your organization is of significant size\u2014it may make sense to issue a formal RFI or request for proposal (RFP) and have laboratory informatics vendors approach your lab with how they can meet its needs. The RFI and RFP are traditional means towards soliciting bidding interest in an organization's project, containing the organization's specific requirements and vital questions that the bidder should be able to effectively answer. However, even if your organization chooses to skip the RFI or RFP process and do most of the investigative work of researching and approaching informatics vendors, turning to a key set of questions typically found in an RFI is extremely valuable towards your fact finding.\n<\/p><p>An RFI is an ideal means for learning more about a potential solution and how it can solve your problems, or for when you're not even sure how to solve your problem yet. However, the RFI should not be unduly long and tedious to complete for prospective vendors; it should be concise, direct, and honest. This means not only presenting a clear and humble vision of your own organization and its goals, but also asking just the right amount of questions to allow potential vendors to demonstrate their expertise and provide a clearer picture of who they are. Some take a technical approach to an RFI, using dense language and complicated spreadsheets for fact finding. However, as previously noted, you will want to limit the specified requirements in your RFI to those carefully chosen because they matter to you and your lab the most.<sup id=\"rdp-ebb-cite_ref-HolmesItsAMatch_1-0\" class=\"reference\"><a href=\"#cite_note-HolmesItsAMatch-1\">[1]<\/a><\/sup> \n<\/p><p>Remember, an RFI is not meant to answer all of your questions. The RFI is meant as a means to help narrow down your search to a few quality candidates while learning more about each other.<sup id=\"rdp-ebb-cite_ref-HolmesItsAMatch_1-1\" class=\"reference\"><a href=\"#cite_note-HolmesItsAMatch-1\">[1]<\/a><\/sup> Once the pool of potential software vendors is narrowed down, and you then participate in their demonstrations, you then can broadly add more requirements to the original collection of critical requirements from the RFI to ensure those providers meet all or most of your needs. That said, be cognizant that there may be no vendor that can meet each and every need of your lab. Your lab will have to make important decisions about which requirements are non-negotiable and which are more flexible. The vendors you engage with may be able to provide realistic advice in this regard, based upon your lab's requirements and their past experience with labs. As such, those vendors with real-world experience meeting the needs of manufacturing laboratories may have a strong leg up on other vendors.\n<\/p><p>Again, Appendix 1 of this guide includes a comprehensive specifications document called LIMSpec, from which you can draw the requirements that are most critical to be addressed in an RFI. If you have zero experience developing an RFI, you may want to first seek out various example RFIs on the internet, as well as some basic advice articles on the topic. Some websites may provide templates to examine for further details. Broadly speaking, if you're conducting a full RFI or RFP, you're going to lead with the standard components of an RFI or RFP, including:\n<\/p>\n<ul><li>a table of contents;<\/li>\n<li>an honest introduction and overview of your organization, its goals and problems, and the services sought to solve them;<\/li>\n<li>details on how the RFI or RFP evaluation process will be conducted;<\/li>\n<li>basis for award (if an RFP);<\/li>\n<li>the calendar schedule (including times) for related events;<\/li>\n<li>how to submit the document and any related questions about it, including response format; and<\/li>\n<li>your organization's background, business requirements, and current technical environment.<\/li><\/ul>\n<p>Being honest about your organization, its informatics requirements, and its current technical environment upfront in the RFI or RFP will also ensure that the time spent on the process is optimized for all involved parties. Before submitting any RFI, your lab will want to conduct thorough internal research ensuring everyone understands what the current technology and processes are, and how you all want to shape that with the introduction or updating of laboratory informatics systems. (If your lab has limited to no experience with adding automation and informatics elements to a laboratory, you may want to read through laboratory informatics veteran Joe Liscouski's <a href=\"https:\/\/www.limswiki.org\/index.php\/LII:The_Application_of_Informatics_to_Scientific_Work:_Laboratory_Informatics_for_Newbies\" title=\"LII:The Application of Informatics to Scientific Work: Laboratory Informatics for Newbies\" class=\"wiki-link\" data-key=\"d8b467af534a70312a21f63b61be26cd\"><i>The Application of Informatics to Scientific Work: Laboratory Informatics for Newbies<\/i><\/a> for further insight.) You'll also want to answer critical questions such as \"who will be responsible for maintaining the solution and its security?\" and \"how will our processes and procedures change with the introduction or updating of informatics systems?\". These and other questions make up your business considerations, which should also address the:\n<\/p>\n<ul><li>acquisition and long-term maintenance budget;<\/li>\n<li>diversity of laboratory services offered now and into the future;<\/li>\n<li>level of in-house knowledge and experience with informatics systems and automation;<\/li>\n<li>level of in-house, executive buy-in of informatics adoption; and<\/li>\n<li>need for additional vendor pre-planning.<\/li><\/ul>\n<p>One other note: make it clear in any issued RFI that it's strictly a request for information and not a guarantee to issue a contract with any respondent.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-HolmesItsAMatch-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HolmesItsAMatch_1-0\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-HolmesItsAMatch_1-1\">1.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Holmes, T.. <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/allcloud.io\/blog\/its-a-match-how-to-run-a-good-rfi-rfp-or-rfq-and-find-the-right-partner\/\" target=\"_blank\">\"It's a Match: How to Run a Good RFI, RFP, or RFQ and Find the Right Partner\"<\/a>. <i>AllCloud Blog<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/allcloud.io\/blog\/its-a-match-how-to-run-a-good-rfi-rfp-or-rfq-and-find-the-right-partner\/\" target=\"_blank\">https:\/\/allcloud.io\/blog\/its-a-match-how-to-run-a-good-rfi-rfp-or-rfq-and-find-the-right-partner\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=It%27s+a+Match%3A+How+to+Run+a+Good+RFI%2C+RFP%2C+or+RFQ+and+Find+the+Right+Partner&rft.atitle=AllCloud+Blog&rft.aulast=Holmes%2C+T.&rft.au=Holmes%2C+T.&rft_id=https%3A%2F%2Fallcloud.io%2Fblog%2Fits-a-match-how-to-run-a-good-rfi-rfp-or-rfq-and-find-the-right-partner%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230516220216\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.077 seconds\nReal time usage: 0.099 seconds\nPreprocessor visited node count: 677\/1000000\nPost\u2010expand include size: 11017\/2097152 bytes\nTemplate argument size: 2165\/2097152 bytes\nHighest expansion depth: 14\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 1936\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 87.989 1 -total\n 75.19% 66.160 1 Template:Reflist\n 55.22% 48.585 1 Template:Cite_web\n 45.95% 40.434 1 Template:Citation\/core\n 24.61% 21.654 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\n 9.68% 8.514 2 Template:Citation\/make_link\n 6.44% 5.666 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14187-0!canonical and timestamp 20230516220218 and revision id 52011. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","33d82d5dd5f85fea7ef356a3cc2dbbf0_images":[],"33d82d5dd5f85fea7ef356a3cc2dbbf0_timestamp":1684275144,"de02f90651071c032712ced29a801111_type":"article","de02f90651071c032712ced29a801111_title":"5.1 Conduct initial research into a specification document tailored to your lab's needs","de02f90651071c032712ced29a801111_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs","de02f90651071c032712ced29a801111_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Taking the next step\/Conduct initial research into a specification document tailored to your lab's needsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n5. Taking the next step \nIn section 3.4 of this guide, we briefly discussed how a user requirements specification (URS) fits into the process of purchasing laboratory informatics solutions for your manufacturing-focused laboratory. The URS has been viewed as a means for the purchaser to ensure their needs are satisfied by the functionality of the software. Traditionally, this has turned into a \"wish list\" for the purchaser, which while somewhat practical still lacks in its finesse. One common problem with this wishlist approach is the risk of \"requirements creep,\" where more functionality than is truly necessary is desired, inevitably leading to a state where no vendor can meet all the wishlisted requirements. This makes selecting a solution even more difficult, particularly without significant prioritization skills.[1][2][3]\nNoting the potential problems with this wishlist approach, LIMSpec\u2014a specification document for laboratory informatics solutions\u2014took a new approach and turned to standards and regulations that drive laboratories of all types, as well as the data they manage. LIMSpec was rebuilt based on ASTM E1578-18 Standard Guide for Laboratory Informatics, as well as dozens of other standards and regulations, while still leaving room for a software buyer to add their own custom requirements for their industry or lab. \nThe rest of this chapter examines the research, documentation, and acquisition process that manufacturing labs needing laboratory informatics solutions will want to go through, with an emphasis on the utility of a sound requirements specification. While LIMSpec is offered as a solid starting point, you don't strictly need to use LIMSpec to conduct this process; the information in this chapter can largely be applied with or without LIMSpec itself.\n\r\n\n\n 5.1 Conduct initial research into a specification document tailored to your lab's needs \nA specification is \"a detailed precise presentation of something or of a plan or proposal for something.\"[4] This concept of a specification as a presentation is critical to the laboratory seeking to find laboratory informatics software that fulfills their needs; they \"present\" their use case with the help of a requirements specification, and the vendor \"presents\" their ability (or inability) to comply through documentation and demonstration (more on that later). However, even the most seasoned of presenters at conferences and the like still require quality preparation before the presentation. This is where initial specification research comes into play for the lab.\nYour lab's requirements specification document will eventually be a critical component for effectively selecting a laboratory informatics solution. There are numerous ways to approach the overall development of such a document. But why re-invent the wheel when others have already gone down that road? Sure, you could search for examples of such documents on the internet and customize them to your needs, or you and your team could brainstorm how a laboratory informatics solution should help your lab accomplish its goals. LIMSpec makes for one of the more thorough starting points to use, though you could also use other structured documents that have been developed by others. For the purposes of this guide, we'll look at LIMSpec.\nThe version of LIMSpec included in Appendix 1 of this guide is a slightly tweaked version of the original LIMSpec 2022 document, omitting a few of the specialty laboratory functions that aren't applicable to manufacturing laboratories. You'll note that it's divided into five distinct sections, with numerous subsections in each:\n\nPrimary Laboratory Workflow\n1. Sample and experiment registration\n2. Sample management\n3. Core laboratory testing and experiments\n4. Results review and verification\n5. Sample, experiment, and study approval and verification\n6. Reporting\nMaintaining Laboratory Workflow and Operations\n7. Document and records management\n8. Resource management\n9. Compliance management\n10. Instrument and equipment management\n11. Batch and lot management\n12. Scheduled event management\n13. Instrument data capture and control\n14. Standard and reagent management\n15. Inventory management\n16. Investigation and quality management\nSpecialty Laboratory Functions (minus non-relevant industries)\n17. Production management\n18. Statistical trending and control charts\n19. Agriculture and food data management\n24. Scientific data management\nTechnology and Performance Improvements\n26. Instrument data systems functions\n27. Systems integration\n28. Laboratory scheduling and capacity planning\n29. Lean laboratory and continuous improvement\n30. Artificial intelligence and smart systems\nSecurity and Integrity of Systems and Operations\n31. Data integrity\n32. Configuration management\n33. System validation and commission\n34. System administration\n35. Cybersecurity\n36. Information privacy\nThese sections and subsections should be able to address most any requirement you have for your system. Of course, if something isn't covered by LIMSpec, you can always add additional requirements. \nDuring the initial research towards your URS, you won't have to include every requirement for when you approach potential vendors. Most vendors appreciate a more inviting approach that doesn't overwhelm, at least initially. You will want to go with a limited yet practical set of requirements carefully chosen because they matter to you and your laboratory the most. In fact, you'll want to wait until after participating in several software demonstrations before even considering your URS to be complete. (More on that in 5.3.1.) This naturally leads us to a discussion about the RFI process.\n\nReferences \n\n\n\u2191 Aasem, M.; Ramzan, M.; Jaffar, A. (2010). \"Analysis and optimization of software requirements prioritization techniques\". Proceedings from the 2010 International Conference on Information and Emerging Technologies: 1\u20136. doi:10.1109\/ICIET.2010.5625687.   \n \n\n\u2191 Hirsch, J. (22 November 2013). \"10 Steps To Successful Requirements Gathering\". Phase2 Technology, LLC. https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering . Retrieved 07 December 2022 .   \n \n\n\u2191 Burris, E. (2007). \"Requirements Specification\". CS451R, University of Missouri\u2013Kansas City. University of Missouri\u2013Kansas City. Archived from the original on 25 September 2019. https:\/\/web.archive.org\/web\/20190925003040\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 \"specification\". Merriam-Webster. Merriam-Webster, Inc. https:\/\/www.merriam-webster.com\/dictionary\/specification . Retrieved 07 December 2022 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:01.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed once.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","de02f90651071c032712ced29a801111_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Taking_the_next_step_Conduct_initial_research_into_a_specification_document_tailored_to_your_lab_s_needs rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Taking_the_next_step_Conduct_initial_research_into_a_specification_document_tailored_to_your_lab_s_needs skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Taking the next step\/Conduct initial research into a specification document tailored to your lab's needs<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"5._Taking_the_next_step\">5. Taking the next step<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Specification_leading_to_Design_Documents.jpg\" class=\"image wiki-link\" data-key=\"722f3b0827301fee01cb9f3569f953a4\"><img alt=\"Specification leading to Design Documents.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/3\/3c\/Specification_leading_to_Design_Documents.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>In section 3.4 of this guide, we briefly discussed how a user requirements specification (URS) fits into the process of purchasing <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> solutions for your manufacturing-focused <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a>. The URS has been viewed as a means for the purchaser to ensure their needs are satisfied by the functionality of the software. Traditionally, this has turned into a \"wish list\" for the purchaser, which while somewhat practical still lacks in its finesse. One common problem with this wishlist approach is the risk of \"requirements creep,\" where more functionality than is truly necessary is desired, inevitably leading to a state where no vendor can meet all the wishlisted requirements. This makes selecting a solution even more difficult, particularly without significant prioritization skills.<sup id=\"rdp-ebb-cite_ref-AasemAnalysis10_1-0\" class=\"reference\"><a href=\"#cite_note-AasemAnalysis10-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Hirsch10Steps13_2-0\" class=\"reference\"><a href=\"#cite_note-Hirsch10Steps13-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BurrissSoftware07_3-0\" class=\"reference\"><a href=\"#cite_note-BurrissSoftware07-3\">[3]<\/a><\/sup>\n<\/p><p>Noting the potential problems with this wishlist approach, <a href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec_2022_R2\" title=\"LII:LIMSpec 2022 R2\" class=\"wiki-link\" data-key=\"fcfd093af650d866ae1ed9ed8bbc08f9\">LIMSpec<\/a>\u2014a specification document for laboratory informatics solutions\u2014took a new approach and turned to standards and regulations that drive laboratories of all types, as well as the data they manage. LIMSpec was rebuilt based on <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> <i>Standard Guide for Laboratory Informatics<\/i>, as well as dozens of other standards and regulations, while still leaving room for a software buyer to add their own custom requirements for their industry or lab. \n<\/p><p>The rest of this chapter examines the research, documentation, and acquisition process that manufacturing labs needing laboratory informatics solutions will want to go through, with an emphasis on the utility of a sound requirements specification. While LIMSpec is offered as a solid starting point, you don't strictly need to use LIMSpec to conduct this process; the information in this chapter can largely be applied with or without LIMSpec itself.\n<\/p><p><br \/>\n<\/p>\n<h3><span id=\"rdp-ebb-5.1_Conduct_initial_research_into_a_specification_document_tailored_to_your_lab's_needs\"><\/span><span class=\"mw-headline\" id=\"5.1_Conduct_initial_research_into_a_specification_document_tailored_to_your_lab.27s_needs\">5.1 Conduct initial research into a specification document tailored to your lab's needs<\/span><\/h3>\n<p>A specification is \"a detailed precise presentation of something or of a plan or proposal for something.\"<sup id=\"rdp-ebb-cite_ref-MWSpec_4-0\" class=\"reference\"><a href=\"#cite_note-MWSpec-4\">[4]<\/a><\/sup> This concept of a specification as a presentation is critical to the laboratory seeking to find laboratory informatics software that fulfills their needs; they \"present\" their use case with the help of a requirements specification, and the vendor \"presents\" their ability (or inability) to comply through documentation and demonstration (more on that later). However, even the most seasoned of presenters at conferences and the like still require quality preparation before the presentation. This is where initial specification research comes into play for the lab.\n<\/p><p>Your lab's requirements specification document will eventually be a critical component for effectively selecting a laboratory informatics solution. There are numerous ways to approach the overall development of such a document. But why re-invent the wheel when others have already gone down that road? Sure, you could search for examples of such documents on the internet and customize them to your needs, or you and your team could brainstorm how a laboratory informatics solution should help your lab accomplish its goals. LIMSpec makes for one of the more thorough starting points to use, though you could also use other structured documents that have been developed by others. For the purposes of this guide, we'll look at LIMSpec.\n<\/p><p>The version of LIMSpec included in Appendix 1 of this guide is a slightly tweaked version of the original <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMSpec_2022_R2\" title=\"Book:LIMSpec 2022 R2\" class=\"wiki-link\" data-key=\"df2e12ebefc2379e95f3f1956aac4400\">LIMSpec 2022<\/a> document, omitting a few of the specialty laboratory functions that aren't applicable to manufacturing laboratories. You'll note that it's divided into five distinct sections, with numerous subsections in each:\n<\/p>\n<ul><li>Primary Laboratory Workflow\n<ul><li>1. Sample and experiment registration<\/li>\n<li>2. Sample management<\/li>\n<li>3. Core laboratory testing and experiments<\/li>\n<li>4. Results review and verification<\/li>\n<li>5. Sample, experiment, and study approval and verification<\/li>\n<li>6. Reporting<\/li><\/ul><\/li>\n<li>Maintaining Laboratory Workflow and Operations\n<ul><li>7. Document and records management<\/li>\n<li>8. Resource management<\/li>\n<li>9. Compliance management<\/li>\n<li>10. Instrument and equipment management<\/li>\n<li>11. Batch and lot management<\/li>\n<li>12. Scheduled event management<\/li>\n<li>13. Instrument data capture and control<\/li>\n<li>14. Standard and reagent management<\/li>\n<li>15. Inventory management<\/li>\n<li>16. Investigation and quality management<\/li><\/ul><\/li>\n<li>Specialty Laboratory Functions (minus non-relevant industries)\n<ul><li>17. Production management<\/li>\n<li>18. Statistical trending and control charts<\/li>\n<li>19. Agriculture and food data management<\/li>\n<li>24. Scientific data management<\/li><\/ul><\/li>\n<li>Technology and Performance Improvements\n<ul><li>26. Instrument data systems functions<\/li>\n<li>27. Systems integration<\/li>\n<li>28. Laboratory scheduling and capacity planning<\/li>\n<li>29. Lean laboratory and continuous improvement<\/li>\n<li>30. Artificial intelligence and smart systems<\/li><\/ul><\/li>\n<li>Security and Integrity of Systems and Operations\n<ul><li>31. Data integrity<\/li>\n<li>32. Configuration management<\/li>\n<li>33. System validation and commission<\/li>\n<li>34. System administration<\/li>\n<li>35. Cybersecurity<\/li>\n<li>36. Information privacy<\/li><\/ul><\/li><\/ul>\n<p>These sections and subsections should be able to address most any requirement you have for your system. Of course, if something isn't covered by LIMSpec, you can always add additional requirements. \n<\/p><p>During the initial research towards your URS, you won't have to include every requirement for when you approach potential vendors. Most vendors appreciate a more inviting approach that doesn't overwhelm, at least initially. You will want to go with a limited yet practical set of requirements carefully chosen because they matter to you and your laboratory the most. In fact, you'll want to wait until after participating in several software demonstrations before even considering your URS to be complete. (More on that in 5.3.1.) This naturally leads us to a discussion about the RFI process.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-AasemAnalysis10-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AasemAnalysis10_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Aasem, M.; Ramzan, M.; Jaffar, A. (2010). \"Analysis and optimization of software requirements prioritization techniques\". <i>Proceedings from the 2010 International Conference on Information and Emerging Technologies<\/i>: 1\u20136. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1109%2FICIET.2010.5625687\" target=\"_blank\">10.1109\/ICIET.2010.5625687<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Analysis+and+optimization+of+software+requirements+prioritization+techniques&rft.jtitle=Proceedings+from+the+2010+International+Conference+on+Information+and+Emerging+Technologies&rft.aulast=Aasem%2C+M.%3B+Ramzan%2C+M.%3B+Jaffar%2C+A.&rft.au=Aasem%2C+M.%3B+Ramzan%2C+M.%3B+Jaffar%2C+A.&rft.date=2010&rft.pages=1%E2%80%936&rft_id=info:doi\/10.1109%2FICIET.2010.5625687&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Hirsch10Steps13-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Hirsch10Steps13_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Hirsch, J. (22 November 2013). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering\" target=\"_blank\">\"10 Steps To Successful Requirements Gathering\"<\/a>. Phase2 Technology, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering\" target=\"_blank\">https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=10+Steps+To+Successful+Requirements+Gathering&rft.atitle=&rft.aulast=Hirsch%2C+J.&rft.au=Hirsch%2C+J.&rft.date=22+November+2013&rft.pub=Phase2+Technology%2C+LLC&rft_id=https%3A%2F%2Fwww.phase2technology.com%2Fblog%2Fsuccessful-requirements-gathering&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BurrissSoftware07-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BurrissSoftware07_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Burris, E. (2007). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20190925003040\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">\"Requirements Specification\"<\/a>. <i>CS451R, University of Missouri\u2013Kansas City<\/i>. University of Missouri\u2013Kansas City. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">the original<\/a> on 25 September 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20190925003040\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20190925003040\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Requirements+Specification&rft.atitle=CS451R%2C+University+of+Missouri%E2%80%93Kansas+City&rft.aulast=Burris%2C+E.&rft.au=Burris%2C+E.&rft.date=2007&rft.pub=University+of+Missouri%E2%80%93Kansas+City&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20190925003040%2Fhttp%3A%2F%2Fsce2.umkc.edu%2FBIT%2Fburrise%2Fpl%2Frequirements%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MWSpec-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MWSpec_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.merriam-webster.com\/dictionary\/specification\" target=\"_blank\">\"specification\"<\/a>. <i>Merriam-Webster<\/i>. Merriam-Webster, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.merriam-webster.com\/dictionary\/specification\" target=\"_blank\">https:\/\/www.merriam-webster.com\/dictionary\/specification<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=specification&rft.atitle=Merriam-Webster&rft.pub=Merriam-Webster%2C+Inc&rft_id=https%3A%2F%2Fwww.merriam-webster.com%2Fdictionary%2Fspecification&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230516220153\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.178 seconds\nReal time usage: 0.248 seconds\nPreprocessor visited node count: 2784\/1000000\nPost\u2010expand include size: 25821\/2097152 bytes\nTemplate argument size: 7717\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 6613\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 210.755 1 -total\n 85.27% 179.720 1 Template:Reflist\n 55.64% 117.254 4 Template:Citation\/core\n 37.99% 80.064 1 Template:Cite_journal\n 29.62% 62.436 3 Template:Cite_web\n 14.63% 30.827 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab's_needs\n 14.08% 29.680 1 Template:Citation\/identifier\n 9.02% 19.009 2 Template:Date\n 6.67% 14.063 7 Template:Citation\/make_link\n 5.68% 11.962 1 Template:Only_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14186-0!canonical and timestamp 20230516220158 and revision id 52010. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","de02f90651071c032712ced29a801111_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/3\/3c\/Specification_leading_to_Design_Documents.jpg"],"de02f90651071c032712ced29a801111_timestamp":1684275144,"d3a97a2b2c8dcf637dcbc673e170382d_type":"article","d3a97a2b2c8dcf637dcbc673e170382d_title":"4.4 LIMSpec","d3a97a2b2c8dcf637dcbc673e170382d_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec","d3a97a2b2c8dcf637dcbc673e170382d_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Resources for selecting and implementing informatics solutions\/LIMSpecFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n4.4 LIMSpec \nLIMSpec is an ever-evolving set of software user requirements specifications for laboratory informatics systems. The specification has grown significantly from its humble origins over a decade ago. Earlier versions of LIMSpec focused on a mix of both regulatory requirements and clients' \"wishlist\" features for a given system. The wishlist items haven't necessarily been ignored by developers, but they do in fact have to be prioritized by the potential buyer as \"nice to have\" or \"essential to system operation,\" or something in between.[1][2][3] This latest version is different, focusing strictly on a regulatory-, standards-, and guidance-based approach to building a specification document for laboratory informatics systems. \nAt its core, LIMSpec is rooted in ASTM E1578-18 Standard Guide for Laboratory Informatics. With the latest version released in 2018, the standard includes an updated Laboratory Informatics Functional Requirements checklist, which \"covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide.\" It goes on to state that the checklist \"is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system,\" though it is certainly \"not meant to be exhaustive.\"\nLIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained. However, the LIMSpec should also definitely be considered a continual work in progress, with more to be added as new pertinent regulations, standards, and guidance are discovered.\nIf you've never worked with a user requirements specification document, the concept remains relatively simple to grasp. Merriam-Webster defines a \"specification\" as \"a detailed precise presentation of something or of a plan or proposal for something.\"[4] Within this organized \"plan or proposal\" are requirements. A requirement typically comes in the form of a statement that begins with \"the system\/user\/vendor shall\/should ...\" and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level), or it may be specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered. \nAn example of a functional software requirement could be \"the user shall be able to query either all of the initial set of databases or select a subset from it.\" This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state \"the system's query tool shall conform to the ABC 123-2014 standard.\" The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.[5]\nThe next chapter discusses the user requirements specification, using LIMSpec as an example. You'll learn how to shape such a specification to your laboratory's needs, how to issue the specification as a request for information (RFI), and how to get the most out of it when getting decision-related information from vendors. Additionally, in Appendix 1, you'll find a blank version of LIMSpec for practical use.\n\nReferences \n\n\n\u2191 Aasem, M.; Ramzan, M.; Jaffar, A. (2010). \"Analysis and optimization of software requirements prioritization techniques\". Proceedings from the 2010 International Conference on Information and Emerging Technologies: 1\u20136. doi:10.1109\/ICIET.2010.5625687.   \n \n\n\u2191 Hirsch, J. (22 November 2013). \"10 Steps To Successful Requirements Gathering\". Phase2 Technology, LLC. https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering . Retrieved 07 December 2022 .   \n \n\n\u2191 Burris, E. (2007). \"Requirements Specification\". CS451R, University of Missouri\u2013Kansas City. University of Missouri\u2013Kansas City. Archived from the original on 24 July 2019. https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 \"specification\". Merriam-Webster. Merriam-Webster, Inc. https:\/\/www.merriam-webster.com\/dictionary\/specification . Retrieved 07 December 2022 .   \n \n\n\u2191 Memon, A. (Spring 2010). \"Software Requirements: Descriptions and specifications of a system\" (PDF). University of Maryland. https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf . Retrieved 07 December 2022 .   \n \n\n\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 4. Resources for selecting and implementing informatics solutions\nTitle: LIMS Selection Guide for Manufacturing Quality Control\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: May 2023\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:01.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 3 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","d3a97a2b2c8dcf637dcbc673e170382d_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Resources_for_selecting_and_implementing_informatics_solutions_LIMSpec rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Resources_for_selecting_and_implementing_informatics_solutions_LIMSpec skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Resources for selecting and implementing informatics solutions\/LIMSpec<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"4.4_LIMSpec\">4.4 LIMSpec<\/span><\/h3>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:LIMSpec.png\" class=\"image wiki-link\" data-key=\"458080cdb6c7fba72b986707492b5a98\"><img alt=\"LIMSpec.png\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/9\/97\/LIMSpec.png\" decoding=\"async\" width=\"240\" height=\"105\" \/><\/a><\/div><p><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMSpec_2022_R2\" title=\"Book:LIMSpec 2022 R2\" class=\"wiki-link\" data-key=\"df2e12ebefc2379e95f3f1956aac4400\">LIMSpec<\/a> is an ever-evolving set of software user requirements specifications for laboratory informatics systems. The specification has grown significantly from its humble origins over a decade ago. Earlier versions of LIMSpec focused on a mix of both regulatory requirements and clients' \"wishlist\" features for a given system. The wishlist items haven't necessarily been ignored by developers, but they do in fact have to be prioritized by the potential buyer as \"nice to have\" or \"essential to system operation,\" or something in between.<sup id=\"rdp-ebb-cite_ref-AasemAnalysis10_1-0\" class=\"reference\"><a href=\"#cite_note-AasemAnalysis10-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Hirsch10Steps13_2-0\" class=\"reference\"><a href=\"#cite_note-Hirsch10Steps13-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BurrissSoftware07_3-0\" class=\"reference\"><a href=\"#cite_note-BurrissSoftware07-3\">[3]<\/a><\/sup> This latest version is different, focusing strictly on a regulatory-, standards-, and guidance-based approach to building a specification document for laboratory informatics systems. \n<\/p><p>At its core, LIMSpec is rooted in <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> <i>Standard Guide for Laboratory Informatics<\/i>. With the latest version released in 2018, the standard includes an updated Laboratory Informatics Functional Requirements checklist, which \"covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide.\" It goes on to state that the checklist \"is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system,\" though it is certainly \"not meant to be exhaustive.\"\n<\/p><p>LIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained. However, the LIMSpec should also definitely be considered a continual work in progress, with more to be added as new pertinent regulations, standards, and guidance are discovered.\n<\/p><p>If you've never worked with a user requirements specification document, the concept remains relatively simple to grasp. Merriam-Webster defines a \"specification\" as \"a detailed precise presentation of something or of a plan or proposal for something.\"<sup id=\"rdp-ebb-cite_ref-MWSpec_4-0\" class=\"reference\"><a href=\"#cite_note-MWSpec-4\">[4]<\/a><\/sup> Within this organized \"plan or proposal\" are requirements. A requirement typically comes in the form of a statement that begins with \"the system\/user\/vendor shall\/should ...\" and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level), or it may be specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered. \n<\/p><p>An example of a functional software requirement could be \"the user shall be able to query either all of the initial set of databases or select a subset from it.\" This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state \"the system's query tool shall conform to the ABC 123-2014 standard.\" The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.<sup id=\"rdp-ebb-cite_ref-MemonSoftware10_5-0\" class=\"reference\"><a href=\"#cite_note-MemonSoftware10-5\">[5]<\/a><\/sup>\n<\/p><p>The next chapter discusses the user requirements specification, using LIMSpec as an example. You'll learn how to shape such a specification to your laboratory's needs, how to issue the specification as a request for information (RFI), and how to get the most out of it when getting decision-related information from vendors. Additionally, in Appendix 1, you'll find a blank version of LIMSpec for practical use.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-AasemAnalysis10-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AasemAnalysis10_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Aasem, M.; Ramzan, M.; Jaffar, A. (2010). \"Analysis and optimization of software requirements prioritization techniques\". <i>Proceedings from the 2010 International Conference on Information and Emerging Technologies<\/i>: 1\u20136. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1109%2FICIET.2010.5625687\" target=\"_blank\">10.1109\/ICIET.2010.5625687<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Analysis+and+optimization+of+software+requirements+prioritization+techniques&rft.jtitle=Proceedings+from+the+2010+International+Conference+on+Information+and+Emerging+Technologies&rft.aulast=Aasem%2C+M.%3B+Ramzan%2C+M.%3B+Jaffar%2C+A.&rft.au=Aasem%2C+M.%3B+Ramzan%2C+M.%3B+Jaffar%2C+A.&rft.date=2010&rft.pages=1%E2%80%936&rft_id=info:doi\/10.1109%2FICIET.2010.5625687&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Hirsch10Steps13-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Hirsch10Steps13_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Hirsch, J. (22 November 2013). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering\" target=\"_blank\">\"10 Steps To Successful Requirements Gathering\"<\/a>. Phase2 Technology, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering\" target=\"_blank\">https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=10+Steps+To+Successful+Requirements+Gathering&rft.atitle=&rft.aulast=Hirsch%2C+J.&rft.au=Hirsch%2C+J.&rft.date=22+November+2013&rft.pub=Phase2+Technology%2C+LLC&rft_id=https%3A%2F%2Fwww.phase2technology.com%2Fblog%2Fsuccessful-requirements-gathering&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BurrissSoftware07-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BurrissSoftware07_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Burris, E. (2007). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">\"Requirements Specification\"<\/a>. <i>CS451R, University of Missouri\u2013Kansas City<\/i>. University of Missouri\u2013Kansas City. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">the original<\/a> on 24 July 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Requirements+Specification&rft.atitle=CS451R%2C+University+of+Missouri%E2%80%93Kansas+City&rft.aulast=Burris%2C+E.&rft.au=Burris%2C+E.&rft.date=2007&rft.pub=University+of+Missouri%E2%80%93Kansas+City&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20190724173601%2Fhttp%3A%2F%2Fsce2.umkc.edu%2FBIT%2Fburrise%2Fpl%2Frequirements%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MWSpec-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MWSpec_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.merriam-webster.com\/dictionary\/specification\" target=\"_blank\">\"specification\"<\/a>. <i>Merriam-Webster<\/i>. Merriam-Webster, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.merriam-webster.com\/dictionary\/specification\" target=\"_blank\">https:\/\/www.merriam-webster.com\/dictionary\/specification<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=specification&rft.atitle=Merriam-Webster&rft.pub=Merriam-Webster%2C+Inc&rft_id=https%3A%2F%2Fwww.merriam-webster.com%2Fdictionary%2Fspecification&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MemonSoftware10-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MemonSoftware10_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Memon, A. (Spring 2010). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf\" target=\"_blank\">\"Software Requirements: Descriptions and specifications of a system\"<\/a> (PDF). University of Maryland<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf\" target=\"_blank\">https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Requirements%3A+Descriptions+and+specifications+of+a+system&rft.atitle=&rft.aulast=Memon%2C+A.&rft.au=Memon%2C+A.&rft.date=Spring+2010&rft.pub=University+of+Maryland&rft_id=https%3A%2F%2Fwww.cs.umd.edu%2F%7Eatif%2FTeaching%2FSpring2010%2FSlides%2F3.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<p><br \/>\n<\/p>\n<div align=\"center\">-----Go to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Taking the next step\/Conduct initial research into a specification document tailored to your lab's needs\" class=\"wiki-link\" data-key=\"de02f90651071c032712ced29a801111\">the next chapter<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: 4. Resources for selecting and implementing informatics solutions\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for Manufacturing Quality Control<\/i>\n<\/p><p><b>Edition<\/b>: First Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: May 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230516220246\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.119 seconds\nReal time usage: 0.141 seconds\nPreprocessor visited node count: 3457\/1000000\nPost\u2010expand include size: 27748\/2097152 bytes\nTemplate argument size: 9236\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 7961\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 118.324 1 -total\n 92.36% 109.290 1 Template:Reflist\n 64.56% 76.387 5 Template:Citation\/core\n 43.50% 51.471 4 Template:Cite_web\n 34.93% 41.332 1 Template:Cite_journal\n 11.23% 13.288 1 Template:Citation\/identifier\n 9.90% 11.719 3 Template:Date\n 7.54% 8.927 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\n 5.70% 6.739 8 Template:Citation\/make_link\n 3.45% 4.083 2 Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14185-0!canonical and timestamp 20230516220245 and revision id 52009. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","d3a97a2b2c8dcf637dcbc673e170382d_images":["https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/9\/97\/LIMSpec.png"],"d3a97a2b2c8dcf637dcbc673e170382d_timestamp":1684275144,"c2e5e2da2eacd71ffb3abe004274bac4_type":"article","c2e5e2da2eacd71ffb3abe004274bac4_title":"4.3 Professional","c2e5e2da2eacd71ffb3abe004274bac4_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/Professional","c2e5e2da2eacd71ffb3abe004274bac4_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Resources for selecting and implementing informatics solutions\/ProfessionalFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 4.3 Professional \n\n1.1 4.3.1 Trade organizations \n1.2 4.3.2 Conferences and trade shows \n\n\n2 References \n\n\n\n4.3 Professional \n4.3.1 Trade organizations \nManufacturing organizations number in the hundreds, with far too many to list here. However, the IQS Manufacturer Directory and its list of manufacturing associations makes for a thorough reference and starting point to all types of manufacturing (at IQSdirectory dot com). Secondarily, specialized listings can also be found. For example, the U.S. Food and Drug Administration (FDA) has its own compendium of cosmetic trade and professional associations. A few examples of broad manufacturing-based trade organizations include the Manufacturing Institute (MI) and the National Association of Manufacturers (NAM).\n\n4.3.2 Conferences and trade shows \nLike trade organizations, conferences and trade shows abound for the various manufacturing-related industries. There are far too many to list here, but representative examples include:\n\nAdvanced Textiles Expo (textiles)\nAIRTEC (aviation)\nFabtech (metals)\nGeneris American Manufacturing Summit (American manufacturing)\nIFT FIRST (food and beverage)\nInternational Conference on Advanced Manufacturing (advanced manufacturing)\nInternational Conference on Metal Material Processes and Manufacturing (metals)\nIPC Apex Expo (electronic circuits)\nOhio State Materials & Manufacturing Conference (materials and manufacturing)\nPromat (manufacturing, distribution, and supply chain)\nSAMPE Conference and Exhibition (materials)\nWestec (aerospace, medical, automotive, and industrial machinery)\nReferences \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/Professional\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/Professional<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 21:58.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 3 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","c2e5e2da2eacd71ffb3abe004274bac4_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Resources_for_selecting_and_implementing_informatics_solutions_Professional rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Resources_for_selecting_and_implementing_informatics_solutions_Professional skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Resources for selecting and implementing informatics solutions\/Professional<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h3><span class=\"mw-headline\" id=\"4.3_Professional\">4.3 Professional<\/span><\/h3>\n<h4><span class=\"mw-headline\" id=\"4.3.1_Trade_organizations\">4.3.1 Trade organizations<\/span><\/h4>\n<p>Manufacturing organizations number in the hundreds, with far too many to list here. However, the IQS Manufacturer Directory and its list of manufacturing associations makes for a thorough reference and starting point to all types of manufacturing (at IQSdirectory dot com). Secondarily, specialized listings can also be found. For example, the U.S. Food and Drug Administration (FDA) has its own compendium of <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/cosmetics\/resources-industry-cosmetics\/cosmetic-trade-and-professional-associations\" target=\"_blank\">cosmetic trade and professional associations<\/a>. A few examples of broad manufacturing-based trade organizations include the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.themanufacturinginstitute.org\/\" target=\"_blank\">Manufacturing Institute (MI)<\/a> and the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nam.org\/\" target=\"_blank\">National Association of Manufacturers (NAM)<\/a>.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"4.3.2_Conferences_and_trade_shows\">4.3.2 Conferences and trade shows<\/span><\/h4>\n<p>Like trade organizations, conferences and trade shows abound for the various manufacturing-related industries. There are far too many to list here, but representative examples include:\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/advancedtextilesexpo.com\/\" target=\"_blank\">Advanced Textiles Expo<\/a> (textiles)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/airtec.aero\/\" target=\"_blank\">AIRTEC<\/a> (aviation)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fabtechexpo.com\/\" target=\"_blank\">Fabtech<\/a> (metals)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/manusummit.com\/\" target=\"_blank\">Generis American Manufacturing Summit<\/a> (American manufacturing)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iftevent.org\/\" target=\"_blank\">IFT FIRST<\/a> (food and beverage)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/amcoe.org\/event\/icam2023\/\" target=\"_blank\">International Conference on Advanced Manufacturing<\/a> (advanced manufacturing)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icmmpm.org\/\" target=\"_blank\">International Conference on Metal Material Processes and Manufacturing<\/a> (metals)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ipcapexexpo.org\/\" target=\"_blank\">IPC Apex Expo<\/a> (electronic circuits)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/imr.osu.edu\/ohio-state-materials-and-manufacturing-conference\/\" target=\"_blank\">Ohio State Materials & Manufacturing Conference<\/a> (materials and manufacturing)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.promatshow.com\/\" target=\"_blank\">Promat<\/a> (manufacturing, distribution, and supply chain)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sampeamerica.org\/\" target=\"_blank\">SAMPE Conference and Exhibition<\/a> (materials)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.westeconline.com\/\" target=\"_blank\">Westec<\/a> (aerospace, medical, automotive, and industrial machinery)<\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<\/div>\n<!-- \nNewPP limit report\nCached time: 20230516215818\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.016 seconds\nReal time usage: 0.024 seconds\nPreprocessor visited node count: 52\/1000000\nPost\u2010expand include size: 2671\/2097152 bytes\nTemplate argument size: 24\/2097152 bytes\nHighest expansion depth: 7\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 16.124 1 -total\n 57.19% 9.221 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/Professional\n 41.89% 6.755 1 Template:Reflist\n 17.58% 2.835 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14184-0!canonical and timestamp 20230516215821 and revision id 52006. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/Professional\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/Professional<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","c2e5e2da2eacd71ffb3abe004274bac4_images":[],"c2e5e2da2eacd71ffb3abe004274bac4_timestamp":1684275144,"f591d51de7768697caa251a97523982a_type":"article","f591d51de7768697caa251a97523982a_title":"4.2 Consultants","f591d51de7768697caa251a97523982a_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/Consultants","f591d51de7768697caa251a97523982a_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Resources for selecting and implementing informatics solutions\/ConsultantsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n4.2 Consultants \nThese consultancies seem to focus primarily on helping others plan, choose, and implement an informatics system for the laboratory, though they may offer other services to laboratories, such as computer system validation (CSV), project management, and workflow development. (The location represents the entity's headquarters.)\n\n\n\n\nVendor\n\nHeadquarters\n\nKey services\n\nServices page\n\n\nA Byte of Advice, Inc.\n\nFairfield, IL, U.S.\n\n\"We provide project management, system development, code modification, support and training\";\r\nexperience with LabVantage and PerkinElmer products\n\nServices page\n\n \n\n\nA2LA Workplace Training\n\nFrederick, MD, U.S.\n\nLIMS, quality management systems, regulatory compliance assessments, process and risk management, etc.\n\nServices page\n\n \n\n\nABB Ltd.\n\nZurich, Switzerland\n\nProvides an expansive set of services.\n\nServices page\n\n\n\n\nAccenture PLC\n\nDublin, Ireland\n\nLaboratory informatics, LIMS, LIS, ELN, data analytics, managed services, etc.\n\nServices page\n\n \n\n\nAKKA Technologies Group\n\nBrussels, Belgium\n\nInformation technology, engineering, clinical data management, regulatory affairs and compliance, etc.\n\nServices page\n\n \n\n\nAstrix, Inc.\n\nRed Bank, NJ, U.S.\n\n\"Astrix\u2019s core competency is to assist organizations in the development and implementation of data\r\nmanagement strategies to enhance the collection, processing, analysis and reporting of scientific data.\"\n\nServices page\n\n\n\n\nAvellana Learning Oy\n\nVantaa, Finland\n\nLIMS, LIS, and ELN implementation; open-source software implementation; software validation; quality control\n\nServices page\n\n\n\n\nBC Solutions, LLC\n\nPhoenix, AZ, U.S.\n\nLIS implementation, interface testing and validation, project management and consulting,\r\ndata conversion\/migration\n\nServices page\n\n\n\n\nBGASoft, Inc. dba LIMS ABC\n\nFort Lauderdale, FL, U.S.\n\nBusiness analysis, lab process improvement, enterprise and cloud architecture, LIMS implementation, etc.\n\nServices page\n\n\n\n\nBika Lab Systems (Pty) Ltd.\n\nWestern Cape, South Africa\n\nLIMS requirement analysis, design, customization, configuration, and testing; training; project management, etc.\n\nServices page\n\n\n\n\nBottom Line Consulting, LLC\n\nEndwell, NY, U.S.\n\nLabware products, user requirements specifications, vendor selection, project management\n\nServices page\n\n\n\n\nBrevitas Consulting, Inc.\n\nSacramento, CA, U.S.\n\nLabware products, LIMS implementation; project management; quality assurance, etc.\n\nServices page\n\n\n\n\nC4 Database Management, Inc.\n\nPort Orchard, WA, U.S.\n\nLIS administration, LIS integrity, data integrity, database installation and migration\n\nServices page\n\n \n\n\nChemtech Servicos de Engenharia e Software Ltda.\n\nRio de Janeiro, Brazil\n\nManufacturing execution systems, SCADA, automation, cyber security, etc.\n\nServices page\n\n\n\n\nClarity Compliance Solutions Limited\n\nChepstow, Wales\n\nLIMS, system validation, data integrity, process mapping, vendor selection, etc.\n\nServices page\n\n\n\n\nClarkston Consulting\n\nDurham, NC, U.S.\n\nLIMS, data integrity, process mapping, vendor selection, quality management, project management etc.\n\nServices page\n\n \n\n\nClevr\n\nNewstead, QLD, Australia\n\nLaboratory process and technology consultations, custom LIMS development\n\nServices page\n\n\n\n\nClinical Lab Consulting, LLC\n\nDublin, OH, U.S.\n\nProvides a wide range of services \"to all types of clinical laboratories including governmental, academia,\r\nhospital, reference and physician office laboratories.\"\n\nServices page\n\n\n\n\nClinical Laboratory Consultants dba Medical Source\n\nMarietta, GA, U.S.\n\n\"Medical Source offers experience, guidance, and unmatched expertise in the physician office and\r\nindependent reference laboratory.\"\n\nServices page\n\n\n\n\nCosine Consultants Ltd.\n\nStrovolos, Cyprus\n\nSoftware customization, data management system consulting, Fission LIMS, etc.\n\nServices page\n\n\n\n\nCSols, Inc.\n\nNewark, DE, U.S.\n\nLaboratory informatics strategic services, ELN and LIMS implementation, computer system validation, and\r\nlaboratory vendor-specific technologies\n\nServices page\n\n \n\n\nDigital Lab Consulting Ltd.\n\nLondon, U.K.\n\nLIMS, LIS, and ELN implementation; computer system validation; business case development;\r\nrequirements definition; project management; vendor selection; etc.\n\nServices page\n\n\n\n\ne-Science Solutions Ltd\n\nWhittington, U.K.\n\nInformation technology, business case development, requirements definition, vendor selection, etc.\n\nServices page\n\n\n\n\nEM2 Solutions, Inc. dba Labtopia\n\nHouston, TX, U.S.\n\nLaboratory informatics strategic services, LIMS implementation, computer system validation,\r\nquality management systems, training, and staffing\n\nServices page\n\n\n\n\nEquixTech\n\nMadrid, Spain\n\nLIMS selection, implementation, and change management; manufacturing execution systems;\r\nautomation; industrial internet of things\n\nServices page\n\n \n\n\nFructeam SARL\n\nParis, France\n\neLearning tools, clinical trial management systems, LIMS, ELN, SDMS, SAP\n\nServices page\n\n\n\n\nHPFM, Inc.\n\nPacifica, CA, U.S.\n\nLIMS selection, implementation, and change management; computer system validation; quality\r\nmanagement systems, etc.\n\nServices page\n\n\n\n\niConnect Consulting, Inc.\n\nSan Francisco, CA, U.S.\n\nLIMS implementation and validation; computer system validation; HL7 electronic communication, training\n\nServices page\n\n\n\n\nIMCOR GmbH\n\nFilderstadt, Germany\n\nLIMS selection and implementation, computer system validation, business process analysis and optimization\n\nServices page\n\n\n\n\nInfoWiz\n\nAnyang, Gyeonggi, South Korea\n\nLIMS, LES, ELN, SDMS, and quality management system selection and implementation; system integration\n\nServices page\n\n\n\n\nKainos Healthcare Solutions, LLC\n\nRichmond, VA, U.S.\n\nLaboratory informatics, LIMS, LIS, EHR, EMR, quality control, procurement and implementation,\r\ncustom development; they also offer a laboratory quality management solution, eQCo\n\nServices page\n\n\n\n\nKalleid, Inc.\n\nCambridge, MA, U.S.\n\n\"We work across the value chain in R&D, clinical and quality areas to deliver support services for software\r\nimplementations in highly complex, multi-site organizations.\"\n\nServices page\n\n \n\n\nLab Insights, LLC\n\nCarlsbad, CA, U.S.\n\nLaboratory informatics, computer system validation, vendor assessment, HIPAA audits and training,\r\nquality assurance, process improvement, etc.\n\nServices page\n\n \n\n\nLabMetrics, LLC\n\nIshpeming, MI, U.S.\n\nLaboratory informatics, automation, instrumentation, compliance and auditing, quality assurance, etc.\n\nServices page\n\n\n\n\nLaboratory Advisory Bureau, LLC\n\nMcAllen, TX, U.S.\n\nClinical laboratory informatics, LIS, quality assurance, compliance and auditing, workflow management, etc.\n\nServices page\n\n\n\n\nLaboratory Systems Consulting\n\nCelbridge, Ireland\n\nLaboratory and scientific informatics, 21 CFR Part 11, project management, etc.\n\nServices page\n\n\n\n\nLIMS4U\n\nBedworth, England\n\nLaboratory informatics, LIMS\n\nServices page\n\n\n\n\nLIMSCON\n\nVienna, Austria\n\nLaboratory informatics, LIMS, ELN, CDMS, document management, training, project management,\r\ncomputer system validation, etc.\n\nServices page\n\n\n\n\nLUFC LabConsultants\n\nMierlo, The Netherlands\n\nLaboratory informatics, LIMS, ELN, CDMS, SDMS, vendor selection, computer system validation,\r\nworkflows, project management, lab management, etc.\n\nServices page\n\n\n\n\nNichols Management Group Ltd.\n\nYork Harbor, ME, U.S.\n\nClinical laboratory informatics, system assessment, implementation, and integration;\r\nproject management; workflow management, etc.\n\nServices page\n\n\n\n\nNNIT A\/S\n\nS\u00f8borg, Denmark\n\nLaboratory informatics; system assessment, implementation, and integration;\r\nsystem validation; project management; workflow management; etc.\n\nServices page\n\n \n\n\nNous Labautomation Support\n\nMariaheide, Netherlands\n\nLaboratory process, automation, and regulation assistance; project management;\r\nLIMS, ELN, CDS, and document management system implementation\n\nServices page\n\n\n\n\nNXG Group, Inc.\n\nChennai, India\n\nLaboratory informatics, LIMS, testing and validation, system integration management,\r\nbusiness consulting, etc.\n\nServices page\n\n\n\n\nOrbis Labsystems Ltd.\n\nDublin, Ireland\n\nLaboratory informatics, LIMS, quality assurance, system integration management, automation, etc.\n\nServices page\n\n\n\n\nOSTHUS GmbH\n\nAachen, Germany\n\nLaboratory informatics, LIMS, system integration management, business consulting, etc.\n\nServices page\n\n \n\n\nprime4services GmbH\n\nKarlsruhe, Germany\n\nLIMS, project management, vendor selection, quality management and validation, etc.\n\nServices page\n\n\n\n\nPQE Group\n\nFlorence, Italy\n\nLaboratory informatics, LIMS, laboratory instrument management, method validation, project management, etc.\n\nServices page\n\n \n\n\nRC Inspection Group\n\nRotterdam, Netherlands\n\nLaboratory informatics, LIMS, data analysis, automation, etc.\n\nServices page\n\n \n\n\nRevereIT, LLC\n\nSterling, VA, U.S.\n\nLIMS, system integration management, system validation, method development and validation,\r\ndata migration, vendor selection, etc.\n\nServices page\n\n\n\n\nSagit Solutions Ltd.\n\nWan Chai, Hong Kong\n\nLIMS, implementation management, cloud management, vendor selection, etc.\n\nServices page\n\n \n\n\nScimcon Limited\n\nNewmarket, Suffolk, U.K.\n\nLaboratory informatics, LIMS, ELN, CDS, SDMS, instrument management, project management\n\nServices page\n\n\n\n\nSemaphore Solutions, Inc.\n\nVictoria, B.C., Canada\n\nLaboratory informatics, LIMS, BaseSpace Clarity LIMS, workflow development, genomics\n\nServices page\n\n\n\n\nSequence, Inc.\n\nMorrisville, NC, U.S.\n\nLaboratory informatics, LIMS, ELN, CDS, SDMS, data architecture analysis, data analytics\n\nServices page\n\n\n\n\nShaw Informatics Ltd.\n\nHorsham, West Sussex, U.K.\n\nLaboratory informatics, LIMS, LES, ELN, process mapping, requirements analysis, project management,\r\nvendor selection, deployment strategy, knowledge management solutions, training\n\nServices page\n\n\n\n\nSilver Lining Informatics, LLC\n\nBrooklyn, NY, U.S.\n\nLaboratory informatics, LIMS, LES, ELN, Labware products, STARLIMS products, LabVantage products,\r\nworkflow development, reporting, project management, training\n\nServices page\n\n \n\n\nSolution4Labs Sp. z o.o.\n\nBia\u0142ystok, Poland\n\nLaboratory informatics, LIMS, ELN, custom development, Thermo Scientific products,\r\nAgaram Technologies products, etc.\n\nServices page\n\n\n\n\nSoftNLabs SpA\n\nCroix, France\n\nLaboratory informatics, LIMS, ELN, LES, SDMS, ERP, CRM, project management, software validation\n\nServices page\n\n \n\n\nTechsol Corporation\n\nPrinceton, NJ, U.S.\n\nLIMS, QMS, MES, regulatory affairs, clinical development, software validation, analytics, etc.\n\nServices page\n\n\n\n\nValidation Systems, Inc.\n\nPalo Alto, CA, U.S.\n\nLaboratory informatics, microbiological and chemistry services, quality management systems,\r\ncomputer system validation, etc.\n\nServices page\n\n\n\n\nVerista\n\nFishers, IN, U.S.\n\nLaboratory informatics, LIMS, ELN, CDS, laboratory compliance assessments, computer system validation,\r\nproject management, etc.\n\nServices page\n\n \n\n\nwega Informatik AG\n\nBasel, Switzerland\n\nLIMS, data management systems design and implementation, clinical trial management systems,\r\nand electronic data capture for life and chemical sciences\n\nServices page\n\n\n\nReferences \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/Consultants\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/Consultants<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 21:58.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 3 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","f591d51de7768697caa251a97523982a_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Resources_for_selecting_and_implementing_informatics_solutions_Consultants rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Resources_for_selecting_and_implementing_informatics_solutions_Consultants skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Resources for selecting and implementing informatics solutions\/Consultants<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"4.2_Consultants\">4.2 Consultants<\/span><\/h3>\n<p>These consultancies seem to focus primarily on helping others plan, choose, and implement an informatics system for the laboratory, though they may offer other services to laboratories, such as computer system validation (CSV), project management, and workflow development. (The location represents the entity's headquarters.)\n<\/p>\n<div style=\"text-align: left;\">\n<table id=\"rdp-ebb-LIMSvendor\" border=\"1\" cellpadding=\"5\" cellspacing=\"0\" align=\"center\" style=\"\">\n<tbody><tr>\n<th>Vendor\n<\/th>\n<th>Headquarters\n<\/th>\n<th>Key services\n<\/th>\n<th>Services page\n<\/th><\/tr>\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.888byteinc.com\/html\/html.html\" target=\"_blank\">A Byte of Advice, Inc.<\/a>\n<\/td>\n<td>Fairfield, IL, U.S.\n<\/td>\n<td>\"We provide project management, system development, code modification, support and training\";<br \/>experience with <a href=\"https:\/\/www.limswiki.org\/index.php\/LABVANTAGE_Solutions,_Inc.\" class=\"mw-redirect wiki-link\" title=\"LABVANTAGE Solutions, Inc.\" data-key=\"0220767e0fd8cb7b9e78e3e8d3b7691d\">LabVantage<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/PerkinElmer_Inc.\" title=\"PerkinElmer Inc.\" class=\"wiki-link\" data-key=\"dabda40785b60866d056709e611512f8\">PerkinElmer<\/a> products\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.888byteinc.com\/html\/html.html\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.a2lawpt.org\/\" target=\"_blank\">A2LA Workplace Training<\/a>\n<\/td>\n<td>Frederick, MD, U.S.\n<\/td>\n<td>LIMS, quality management systems, regulatory compliance assessments, process and risk management, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.a2lawpt.org\/consulting\/custom\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ABB_Ltd.\" title=\"ABB Ltd.\" class=\"wiki-link\" data-key=\"b39f205310adb7bb028a4f0a6960f088\">ABB Ltd.<\/a>\n<\/td>\n<td>Zurich, Switzerland\n<\/td>\n<td>Provides an expansive set of services.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/new.abb.com\/service\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.accenture.com\/\" target=\"_blank\">Accenture PLC<\/a>\n<\/td>\n<td>Dublin, Ireland\n<\/td>\n<td>Laboratory informatics, LIMS, LIS, ELN, data analytics, managed services, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.accenture.com\/us-en\/services\/life-sciences\/scientific-informatics-services\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.akka-technologies.com\/\" target=\"_blank\">AKKA Technologies Group<\/a>\n<\/td>\n<td>Brussels, Belgium\n<\/td>\n<td>Information technology, engineering, clinical data management, regulatory affairs and compliance, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.akka-technologies.com\/sector\/life-sciences\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/astrixinc.com\/\" target=\"_blank\">Astrix, Inc.<\/a>\n<\/td>\n<td>Red Bank, NJ, U.S.\n<\/td>\n<td>\"Astrix\u2019s core competency is to assist organizations in the development and implementation of data<br \/>management strategies to enhance the collection, processing, analysis and reporting of scientific data.\"\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/astrixinc.com\/professional-services\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.avellana.fi\/\" target=\"_blank\">Avellana Learning Oy<\/a>\n<\/td>\n<td>Vantaa, Finland\n<\/td>\n<td>LIMS, LIS, and ELN implementation; open-source software implementation; software validation; quality control\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.avellana.fi\/yrityksille\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bcsolutionsrfn.com\/\" target=\"_blank\">BC Solutions, LLC<\/a>\n<\/td>\n<td>Phoenix, AZ, U.S.\n<\/td>\n<td>LIS implementation, interface testing and validation, project management and consulting,<br \/>data conversion\/migration\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bcsolutionsrfn.com\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BGASoft,_Inc.\" title=\"BGASoft, Inc.\" class=\"wiki-link\" data-key=\"ccea591e377b4c7f4680f27c773e9c8a\">BGASoft, Inc. dba LIMS ABC<\/a>\n<\/td>\n<td>Fort Lauderdale, FL, U.S.\n<\/td>\n<td>Business analysis, lab process improvement, enterprise and cloud architecture, LIMS implementation, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.limsabc.com\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bika_Lab_Systems_(Pty)_Ltd.\" title=\"Bika Lab Systems (Pty) Ltd.\" class=\"wiki-link\" data-key=\"a39862cc41349265a37eb87242d3a628\">Bika Lab Systems (Pty) Ltd.<\/a>\n<\/td>\n<td>Western Cape, South Africa\n<\/td>\n<td>LIMS requirement analysis, design, customization, configuration, and testing; training; project management, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bikalims.org\/bika_senaite_professional_services\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.blcllc.com\/\" target=\"_blank\">Bottom Line Consulting, LLC<\/a>\n<\/td>\n<td>Endwell, NY, U.S.\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabWare,_Inc.\" title=\"LabWare, Inc.\" class=\"wiki-link\" data-key=\"34254ba2e2bbcd4ce616eba66db7d2f6\">Labware<\/a> products, user requirements specifications, vendor selection, project management\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.blcllc.com\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/brevitas.us\/\" target=\"_blank\">Brevitas Consulting, Inc.<\/a>\n<\/td>\n<td>Sacramento, CA, U.S.\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabWare,_Inc.\" title=\"LabWare, Inc.\" class=\"wiki-link\" data-key=\"34254ba2e2bbcd4ce616eba66db7d2f6\">Labware<\/a> products, LIMS implementation; project management; quality assurance, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.brevitas.us\/expertise\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/c4databasemanagement.com\/\" target=\"_blank\">C4 Database Management, Inc.<\/a>\n<\/td>\n<td>Port Orchard, WA, U.S.\n<\/td>\n<td>LIS administration, LIS integrity, data integrity, database installation and migration\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/c4databasemanagement.com\/lis-services\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.chemtech.com.br\/?lang=en\" target=\"_blank\">Chemtech Servicos de Engenharia e Software Ltda.<\/a>\n<\/td>\n<td>Rio de Janeiro, Brazil\n<\/td>\n<td>Manufacturing execution systems, SCADA, automation, cyber security, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.chemtech.com.br\/consultoria\/?lang=en\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.clarity-compliance.com\/\" target=\"_blank\">Clarity Compliance Solutions Limited<\/a>\n<\/td>\n<td>Chepstow, Wales\n<\/td>\n<td>LIMS, system validation, data integrity, process mapping, vendor selection, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.clarity-compliance.com\/services\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clarkstonconsulting.com\/\" target=\"_blank\">Clarkston Consulting<\/a>\n<\/td>\n<td>Durham, NC, U.S.\n<\/td>\n<td>LIMS, data integrity, process mapping, vendor selection, quality management, project management etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clarkstonconsulting.com\/industries\/life-sciences\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.clevr.com.au\/\" target=\"_blank\">Clevr<\/a>\n<\/td>\n<td>Newstead, QLD, Australia\n<\/td>\n<td>Laboratory process and technology consultations, custom LIMS development\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.clevr.com.au\/services\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.clinicallabconsulting.com\/\" target=\"_blank\">Clinical Lab Consulting, LLC<\/a>\n<\/td>\n<td>Dublin, OH, U.S.\n<\/td>\n<td>Provides a wide range of services \"to all types of clinical laboratories including governmental, academia,<br \/>hospital, reference and physician office laboratories.\"\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.clinicallabconsulting.com\/general-consulting\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/consultants-lab.com\/\" target=\"_blank\">Clinical Laboratory Consultants dba Medical Source<\/a>\n<\/td>\n<td>Marietta, GA, U.S.\n<\/td>\n<td>\"Medical Source offers experience, guidance, and unmatched expertise in the physician office and<br \/>independent reference laboratory.\"\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/consultants-lab.com\/laboratory-startup-consultants-clinical-laboratory-consultants\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Cosine_Consultants_Ltd.\" title=\"Cosine Consultants Ltd.\" class=\"wiki-link\" data-key=\"419e894798ea982e9446353344c9b558\">Cosine Consultants Ltd.<\/a>\n<\/td>\n<td>Strovolos, Cyprus\n<\/td>\n<td>Software customization, data management system consulting, <a href=\"https:\/\/www.limswiki.org\/index.php\/Cosine_Consultants_Ltd.#Fission_LIMS\" title=\"Cosine Consultants Ltd.\" class=\"wiki-link\" data-key=\"c1b2cdeeb9baee4f98da0e95aa3dc5b4\">Fission LIMS<\/a>, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cosine.com.cy\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CSols,_Inc.\" title=\"CSols, Inc.\" class=\"wiki-link\" data-key=\"d2fdccdc0381a8bfdfaa0f256f28c3ee\">CSols, Inc.<\/a>\n<\/td>\n<td>Newark, DE, U.S.\n<\/td>\n<td>Laboratory informatics strategic services, ELN and LIMS implementation, computer system validation, and<br \/>laboratory vendor-specific technologies\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.csolsinc.com\/services\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dlc.io\/\" target=\"_blank\">Digital Lab Consulting Ltd.<\/a>\n<\/td>\n<td>London, U.K.\n<\/td>\n<td>LIMS, LIS, and ELN implementation; computer system validation; business case development;<br \/>requirements definition; project management; vendor selection; etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dlc.io\/about-digital-lab-consulting\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.e-sciencesolutions.com\/\" target=\"_blank\">e-Science Solutions Ltd<\/a>\n<\/td>\n<td>Whittington, U.K.\n<\/td>\n<td>Information technology, business case development, requirements definition, vendor selection, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.e-sciencesolutions.com\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labtopiainc.com\/\" target=\"_blank\">EM2 Solutions, Inc. dba Labtopia<\/a>\n<\/td>\n<td>Houston, TX, U.S.\n<\/td>\n<td>Laboratory informatics strategic services, LIMS implementation, computer system validation,<br \/>quality management systems, training, and staffing\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labtopiainc.com\/about-labtopia\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/equixtech.com\/\" target=\"_blank\">EquixTech<\/a>\n<\/td>\n<td>Madrid, Spain\n<\/td>\n<td>LIMS selection, implementation, and change management; manufacturing execution systems;<br \/>automation; industrial internet of things\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/equixtech.com\/index.php\/services\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/fructeam.com\/\" target=\"_blank\">Fructeam SARL<\/a>\n<\/td>\n<td>Paris, France\n<\/td>\n<td>eLearning tools, clinical trial management systems, LIMS, ELN, SDMS, SAP\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/fructeam.com\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hpfm.net\/\" target=\"_blank\">HPFM, Inc.<\/a>\n<\/td>\n<td>Pacifica, CA, U.S.\n<\/td>\n<td>LIMS selection, implementation, and change management; computer system validation; quality<br \/>management systems, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hpfm.net\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/iconnectconsulting.com\/\" target=\"_blank\">iConnect Consulting, Inc.<\/a>\n<\/td>\n<td>San Francisco, CA, U.S.\n<\/td>\n<td>LIMS implementation and validation; computer system validation; HL7 electronic communication, training\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/iconnectconsulting.com\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.imcor.de\/de\/\" target=\"_blank\">IMCOR GmbH<\/a>\n<\/td>\n<td>Filderstadt, Germany\n<\/td>\n<td>LIMS selection and implementation, computer system validation, business process analysis and optimization\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.imcor.de\/de\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.infowiz.kr\/Infowiz_EN\" target=\"_blank\">InfoWiz<\/a>\n<\/td>\n<td>Anyang, Gyeonggi, South Korea\n<\/td>\n<td>LIMS, LES, ELN, SDMS, and quality management system selection and implementation; system integration\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.infowiz.kr\/Infowiz_EN\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/kainoshealthcare.com\/\" target=\"_blank\">Kainos Healthcare Solutions, LLC<\/a>\n<\/td>\n<td>Richmond, VA, U.S.\n<\/td>\n<td>Laboratory informatics, LIMS, LIS, EHR, EMR, quality control, procurement and implementation,<br \/>custom development; they also offer a laboratory quality management solution, eQCo\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/kainoshealthcare.com\/#our-expertise\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Kalleid,_Inc.\" title=\"Kalleid, Inc.\" class=\"wiki-link\" data-key=\"12f59459a3ea995dc9684890ab6a46c7\">Kalleid, Inc.<\/a>\n<\/td>\n<td>Cambridge, MA, U.S.\n<\/td>\n<td>\"We work across the value chain in R&D, clinical and quality areas to deliver support services for software<br \/>implementations in highly complex, multi-site organizations.\"\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.kalleid.com\/services\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labinsightsllc.com\/\" target=\"_blank\">Lab Insights, LLC<\/a>\n<\/td>\n<td>Carlsbad, CA, U.S.\n<\/td>\n<td>Laboratory informatics, computer system validation, vendor assessment, HIPAA audits and training,<br \/>quality assurance, process improvement, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labinsightsllc.com\/services-and-specialties\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/labmetrics.com\/\" target=\"_blank\">LabMetrics, LLC<\/a>\n<\/td>\n<td>Ishpeming, MI, U.S.\n<\/td>\n<td>Laboratory informatics, automation, instrumentation, compliance and auditing, quality assurance, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/labmetrics.com\/services\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.labadvisory.com\/\" target=\"_blank\">Laboratory Advisory Bureau, LLC<\/a>\n<\/td>\n<td>McAllen, TX, U.S.\n<\/td>\n<td>Clinical laboratory informatics, LIS, quality assurance, compliance and auditing, workflow management, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.labadvisory.com\/Our-Services\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.lims.ie\/\" target=\"_blank\">Laboratory Systems Consulting<\/a>\n<\/td>\n<td>Celbridge, Ireland\n<\/td>\n<td>Laboratory and scientific informatics, 21 CFR Part 11, project management, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.lims.ie\/services.html\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/lims4u.co.uk\/\" target=\"_blank\">LIMS4U<\/a>\n<\/td>\n<td>Bedworth, England\n<\/td>\n<td>Laboratory informatics, LIMS\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/lims4u.co.uk\/#services\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/limscon.eu\/\" target=\"_blank\">LIMSCON<\/a>\n<\/td>\n<td>Vienna, Austria\n<\/td>\n<td>Laboratory informatics, LIMS, ELN, CDMS, document management, training, project management,<br \/>computer system validation, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/limscon.eu\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lufc-labconsultants.com\/\" target=\"_blank\">LUFC LabConsultants<\/a>\n<\/td>\n<td>Mierlo, The Netherlands\n<\/td>\n<td>Laboratory informatics, LIMS, ELN, CDMS, SDMS, vendor selection, computer system validation,<br \/>workflows, project management, lab management, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lufc-labconsultants.com\/lufc-labconsultants.html\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nicholsmanagementgroup.com\/\" target=\"_blank\">Nichols Management Group Ltd.<\/a>\n<\/td>\n<td>York Harbor, ME, U.S.\n<\/td>\n<td>Clinical laboratory informatics, system assessment, implementation, and integration;<br \/>project management; workflow management, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nicholsmanagementgroup.com\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nnit.com\/\" target=\"_blank\">NNIT A\/S<\/a>\n<\/td>\n<td>S\u00f8borg, Denmark\n<\/td>\n<td>Laboratory informatics; system assessment, implementation, and integration;<br \/>system validation; project management; workflow management; etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nnit.com\/our-solutions\/laboratory\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.labautomationsupport.nl\/\" target=\"_blank\">Nous Labautomation Support<\/a>\n<\/td>\n<td>Mariaheide, Netherlands\n<\/td>\n<td>Laboratory process, automation, and regulation assistance; project management;<br \/>LIMS, ELN, CDS, and document management system implementation\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.labautomationsupport.nl\/nl\/diensten-aanbod\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nxggroup.com\/\" target=\"_blank\">NXG Group, Inc.<\/a>\n<\/td>\n<td>Chennai, India\n<\/td>\n<td>Laboratory informatics, LIMS, testing and validation, system integration management,<br \/>business consulting, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nxggroup.com\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.orbislabsystems.com\/\" target=\"_blank\">Orbis Labsystems Ltd.<\/a>\n<\/td>\n<td>Dublin, Ireland\n<\/td>\n<td>Laboratory informatics, LIMS, quality assurance, system integration management, automation, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.orbislabsystems.com\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osthus.com\/\" target=\"_blank\">OSTHUS GmbH<\/a>\n<\/td>\n<td>Aachen, Germany\n<\/td>\n<td>Laboratory informatics, LIMS, system integration management, business consulting, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osthus.com\/our-services\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.prime4services.com\/\" target=\"_blank\">prime4services GmbH<\/a>\n<\/td>\n<td>Karlsruhe, Germany\n<\/td>\n<td>LIMS, project management, vendor selection, quality management and validation, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.prime4services.com\/services\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pqegroup.com\/\" target=\"_blank\">PQE Group<\/a>\n<\/td>\n<td>Florence, Italy\n<\/td>\n<td>Laboratory informatics, LIMS, laboratory instrument management, method validation, project management, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pqegroup.com\/laboratory-excellence\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/rc-inspection.com\/\/\" target=\"_blank\">RC Inspection Group<\/a>\n<\/td>\n<td>Rotterdam, Netherlands\n<\/td>\n<td>Laboratory informatics, LIMS, data analysis, automation, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/rc-inspection.com\/laboratory-and-automation-consultancy\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.revereit.com\/\" target=\"_blank\">RevereIT, LLC<\/a>\n<\/td>\n<td>Sterling, VA, U.S.\n<\/td>\n<td>LIMS, system integration management, system validation, method development and validation,<br \/>data migration, vendor selection, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.revereit.com\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sagit-solutions.com\/\" target=\"_blank\">Sagit Solutions Ltd.<\/a>\n<\/td>\n<td>Wan Chai, Hong Kong\n<\/td>\n<td>LIMS, implementation management, cloud management, vendor selection, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sagit-solutions.com\/lims\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/scimcon.com\/\" target=\"_blank\">Scimcon Limited<\/a>\n<\/td>\n<td>Newmarket, Suffolk, U.K.\n<\/td>\n<td>Laboratory informatics, LIMS, ELN, CDS, SDMS, instrument management, project management\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/scimcon.com\/expertise\/is-strategy\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/semaphoresolutions.com\/\" target=\"_blank\">Semaphore Solutions, Inc.<\/a>\n<\/td>\n<td>Victoria, B.C., Canada\n<\/td>\n<td>Laboratory informatics, LIMS, BaseSpace Clarity LIMS, workflow development, genomics\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/semaphoresolutions.com\/laboratory-software-services\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sequenceqcs.com\/\" target=\"_blank\">Sequence, Inc.<\/a>\n<\/td>\n<td>Morrisville, NC, U.S.\n<\/td>\n<td>Laboratory informatics, LIMS, ELN, CDS, SDMS, data architecture analysis, data analytics\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/sequenceqcs.com\/services\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.shawinformatics.com\/\" target=\"_blank\">Shaw Informatics Ltd.<\/a>\n<\/td>\n<td>Horsham, West Sussex, U.K.\n<\/td>\n<td>Laboratory informatics, LIMS, LES, ELN, process mapping, requirements analysis, project management,<br \/>vendor selection, deployment strategy, knowledge management solutions, training\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.shawinformatics.com\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/silverlininginformatics.com\/\" target=\"_blank\">Silver Lining Informatics, LLC<\/a>\n<\/td>\n<td>Brooklyn, NY, U.S.\n<\/td>\n<td>Laboratory informatics, LIMS, LES, ELN, <a href=\"https:\/\/www.limswiki.org\/index.php\/LabWare,_Inc.\" title=\"LabWare, Inc.\" class=\"wiki-link\" data-key=\"34254ba2e2bbcd4ce616eba66db7d2f6\">Labware<\/a> products, <a href=\"https:\/\/www.limswiki.org\/index.php\/STARLIMS_Corporation\" title=\"STARLIMS Corporation\" class=\"wiki-link\" data-key=\"9564e6e2ab70cd1ad0ae68d1ca215524\">STARLIMS<\/a> products, <a href=\"https:\/\/www.limswiki.org\/index.php\/LabVantage_Solutions,_Inc.\" title=\"LabVantage Solutions, Inc.\" class=\"wiki-link\" data-key=\"1855d5158d4dd8f748e925e626daf5ee\">LabVantage<\/a> products,<br \/>workflow development, reporting, project management, training\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/silverlininginformatics.com\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/solution4labs.com\/en\/\" target=\"_blank\">Solution4Labs Sp. z o.o.<\/a>\n<\/td>\n<td>Bia\u0142ystok, Poland\n<\/td>\n<td>Laboratory informatics, LIMS, ELN, custom development, <a href=\"https:\/\/www.limswiki.org\/index.php\/Thermo_Scientific\" title=\"Thermo Scientific\" class=\"wiki-link\" data-key=\"e914753f99d483d4577b35fed71b3c94\">Thermo Scientific<\/a> products,<br \/><a href=\"https:\/\/www.limswiki.org\/index.php\/Agaram_Technologies_Pvt._Ltd.\" title=\"Agaram Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"da3a4846bd90a4735bd580b830ffdade\">Agaram Technologies<\/a> products, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/solution4labs.com\/en\/solutions-and-services\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/softnlabs.com\/en\/\" target=\"_blank\">SoftNLabs SpA<\/a>\n<\/td>\n<td>Croix, France\n<\/td>\n<td>Laboratory informatics, LIMS, ELN, LES, SDMS, ERP, CRM, project management, software validation\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/softnlabs.com\/en\/services\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.techsolcorp.com\/\" target=\"_blank\">Techsol Corporation<\/a>\n<\/td>\n<td>Princeton, NJ, U.S.\n<\/td>\n<td>LIMS, QMS, MES, regulatory affairs, clinical development, software validation, analytics, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.techsolcorp.com\/solutions\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.validationsystems.com\/\" target=\"_blank\">Validation Systems, Inc.<\/a>\n<\/td>\n<td>Palo Alto, CA, U.S.\n<\/td>\n<td>Laboratory informatics, microbiological and chemistry services, quality management systems,<br \/>computer system validation, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.validationsystems.com\/services\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/verista.com\/\" target=\"_blank\">Verista<\/a>\n<\/td>\n<td>Fishers, IN, U.S.\n<\/td>\n<td>Laboratory informatics, LIMS, ELN, CDS, laboratory compliance assessments, computer system validation,<br \/>project management, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/verista.com\/solutions\/lab-systems-informatics\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wega-it.com\/en\/\" target=\"_blank\">wega Informatik AG<\/a>\n<\/td>\n<td>Basel, Switzerland\n<\/td>\n<td>LIMS, data management systems design and implementation, clinical trial management systems,<br \/>and electronic data capture for life and chemical sciences\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wega-it.com\/en\/\" target=\"_blank\">Services page<\/a>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/div>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<\/div>\n<!-- \nNewPP limit report\nCached time: 20230516215804\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.055 seconds\nReal time usage: 0.072 seconds\nPreprocessor visited node count: 79\/1000000\nPost\u2010expand include size: 34406\/2097152 bytes\nTemplate argument size: 24\/2097152 bytes\nHighest expansion depth: 7\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 31.414 1 -total\n 62.76% 19.715 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/Consultants\n 36.69% 11.525 1 Template:Reflist\n 31.83% 10.000 1 Template:LIMS,_LIS,_and_laboratory\n 14.88% 4.676 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14183-0!canonical and timestamp 20230516215805 and revision id 52005. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/Consultants\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/Consultants<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","f591d51de7768697caa251a97523982a_images":[],"f591d51de7768697caa251a97523982a_timestamp":1684275144,"d1c053b2048cf912b5b8f8e81bfa051d_type":"article","d1c053b2048cf912b5b8f8e81bfa051d_title":"4.1 LIMS vendors","d1c053b2048cf912b5b8f8e81bfa051d_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors","d1c053b2048cf912b5b8f8e81bfa051d_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Resources for selecting and implementing informatics solutions\/LIMS vendorsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n4. Resources for selecting and implementing informatics solutions \nThe LIMS vendors and consultants lists are directly pulled from LIMSwiki's maintained tabular listings of these types of entities. The professional section addresses trade organizations, conferences, and more. The last section introduces LIMSpec, which will be addressed further in this guide.\n\r\n\n\n4.1 LIMS vendors \nNOTE: This listing represents all known active LIMS vendors. For a categorized listing of LIMS vendors who publicly indicate they serve a particular manufacturing-related industry, see the categorization of LIMS vendors by industry. In particular, you may want to look at LIMS vendors who specifically market a product to the manufacturing and R&D sector.\n\r\n\n\n\n\n\nVendor\n\nKey LIMS offering(s)\n\nSaaS\r\noption?\n\nHeadquarters\r\n(Country)\n\nKey information\n\nAdditional notes\n\n\n10BioSystems, LLC\n\nLabCentral\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nAAC Infotray AG\n\nLimsophy LIMS\n\nNo\n\nSwitzerland\n\n\n\n\n\n\n\n\nABB Ltd.\n\nKnowledge Manager\n\nYes\n\nUnited States\n\n\n\nSold CCLAS LIMS to Datamine Software Ltd. in August 2019.[1]\n\n \n\n\nABI-Health Technologies Pvt. Ltd.\n\nABI LIMS\n\nNo\n\nIndia\n\n\n\nLIMS is part of the SmartLabs platform.\n\n\n\n\nABS Systems, Inc.\n\nPHIMS\n\nNo\n\nUnited States\n\n\n\n\n\n \n\n\nAdifo NV\n\nBESTMIX LIMS\n\nNo\n\nBelgium\n\n\n\nFormer product Laboras now seems defunct.\n\n\n\n\nAdvanced Solutions Accelerator SAS\n\n100 lims\n\nNo\n\nFrance\n\n\n\n\n\n\n\n\nAdvanced Technical Software\n\nuniLIME\n\nNo\n\nAustria\n\n\n\nFormer product q\/LIME seems no longer supported.\n\n\n\n\nAdvanced Technology Corp.\n\nVADDS, VETSTAR\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nAgaram Technologies Pvt. Ltd.\n\nQualis LIMS\n\nYes\n\nIndia\n\nDemonstration videos\n\n\n\n\n\n\nAgiLab SAS\n\nAgiLIMS\n\nYes\n\nFrance\n\n\n\n\n\n\n\n\nAgile Frameworks, LLC\n\nMetaField\n\nYes\n\nUnited States\n\nDemonstration videos\n\nA field information management system for architecture,\r\nengineering, and construction that contains a full LIMS module\n\n\n\n\nAgileBio\n\nLabCollector\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n\n\n\nAgilent Technologies, Inc.\n\niLab Operations Software, SLIMS\n\nYes\n\nUnited States\n\nDemonstration videos\n\nAgilent acquired the iLab core facility management software in 2016.[2]\r\nAgilent acquired Genohm SA in May 2018.[3][4]\n\n\n\n\nAHP GmbH\n\niQ-LIMS\n\nNo\n\nGermany\n\n\n\n\n\n \n\n\nAINZ Corp.\n\nLabFlow\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\nCannabis-oriented LIMS; former product was PharmWare.\n\n\n\n\nAiZen Algo Pvt. Ltd.\n\nLabZen\n\nNo\n\nIndia\n\n\n\n\n\n \n\n\nAlcor SPRL\n\nCI-Master, LabTec\n\nNo\n\nBelgium\n\n\n\n\n\n\n\n\nAlpha Technologies US, LP\n\nEnterprise\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nAmbidata Digital Innovation Solutions & Consulting, Lda.\n\nLabWay-LIMS\n\nNo\n\nPortugal\n\n\n\n\n\n\n\n\nAmerican Technical Services, Inc.\n\nMOX\n\nNo\n\nUnited States\n\n\n\n\"Laboratory workflow and [metrology] management system\"\r\nwith LIMS module\n\n \n\n\nAnalytical Information Systems, Ltd.\n\nAIS LIMS\n\nNo\n\nUnited Kingdom\n\n\n\n\n\n \n\n\nAquatic Informatics, Inc.\n\nAQUARIUS\n\nYes\n\nCanada\n\nDemonstration videos\n\nNot marketed as a LIMS, but software suite has\r\nextensive LIMS functionality.\n\n \n\n\nASM Soft SL\n\nasmLIMS\n\nNo\n\nSpain\n\n\n\n\n\n\n\n\nAssaynet Inc.\n\nAssaynet LIMS\n\nNo\n\nCanada\n\nDemonstration videos\n\nPrevious name for LIMS2010 was LIMS2003.\n\n\n\n\nAsterian, LLC\n\nArgoLIMS\n\nYes\n\nUnited States\n\n\n\nSee the LIS vendor page for QuikLIMS.\n\n\n\n\nAsystance B.V.\n\nAlisQI LIMS\n\nYes\n\nNetherlands\n\nDemonstration videos\n\n\n\n\n\n\nATGC Labs, LLC\n\nActiveLIMS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nAurora Systems, Inc.\n\nVisuaLab\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nAutoscribe Informatics, Inc.\n\nMatrix Gemini, Matrix Express\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\nNorth American distributor\/support team was\r\nZumatrix, Inc. until it was absorbed into new\r\nentity Autoscribe Informatics, Inc.[5]\n\n\n\n\nBARTELT GmbH\n\ndatalabX\n\nNo\n\nAustria\n\n\n\n\n\n\n\n\nBassetti France SAS\n\nTEEXMA LIMS\n\nNo\n\nFrance\n\n\n\n\n\n\n\n\nBatalyse GmbH\n\nMind\n\nNo\n\nGermany\n\nDemonstration videos\n\n\n\n\n\n\nBaytek International, Inc.\n\ncBLISS\n\nYes\n\nUnited States\n\n\n\nProduct line changed in summer 2017 with introduction of cBLISS.\n\n\n\n\nBeijing Bio-LIMS Soft Co. Ltd.\n\nBio-LIMS\n\nNo\n\nChina\n\n\n\n\n\n \n\n\nBentley Systems, Inc.\n\nKeyLAB\n\nNo\n\nUnited States\n\nPricing and demonstration videos\n\nAcquired Keynetix Ltd. and KeyLAB in 2019.[6]\n\n\n\n\nBGASoft, Inc.\n\nLIMS ABC\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nBika Lab Systems (Pty) Ltd.\n\nBika LIMS\n\nYes\n\nSouth Africa\n\nPricing\n\nAlso available at SourceForge.net under GPL.\n\n\n\n\nBio-Analytical Technologies Pvt. Ltd.\n\nBioClinical\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nBio-ITech BV\n\neLABInventory, eLABJournal\n\nYes\n\nThe Netherlands\n\nPricing and demonstration videos\n\nNeither is a true traditional LIMS; Inventory is a sample manager\r\nand Journal is an ELN with the features of Inventory. However, both\r\nhave LIMS-like features.\n\n \n\n\nBioData Inc.\n\nLabguru\n\nYes\n\nUnited States\n\nDemonstration videos\n\nLabguru replaced LabLife and BioKM on December 5, 2011.[7]\r\nBecame an ELN+LIMS platform in late 2022.\n\n \n\n\nBioFortis, Inc.\n\nLabmatrix\n\nNo\n\nUnited States\n\n\n\n\n\n \n\n\nBioInfoRx, Inc.\n\nmLIMS\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\nAnimal colony management LIMS\n\n\n\n\nBiomatters Ltd.\n\nGeneious\n\nNo\n\nNew Zealand\n\nPricing and demonstration videos\n\n\n\n\n\n\nBiomed Systems Ltd.\n\nLABA\n\nYes\n\nEngland\n\nPricing and demonstration videos\n\nBiotechnology and biobanking LIMS\n\n\n\n\nBioSilicium SASU\n\nbs-LIMS\n\nNo\n\nFrance\n\n\n\n\n\n\n\n\nBit Wave Solutions Ltd.\n\nLabsols LIMS\n\nYes\n\nUnited Kingdom\n\n\n\n\n\n\n\n\nBlaze Systems Corporation\n\nBlazeLIMS\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n\n\n\nBlomesystem GmbH\n\nLABbase\n\nNo\n\nGermany\n\n\n\nreadyLIMS appears to have been discontinued in 2019 or 2020.\n\n \n\n\nBode Cellmark Forensics, Inc.\n\nBodeLIMS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nBrooks Automation, Inc.\n\nFreezerPro, Limfinity\n\nYes\n\nUnited States\n\nPricingand demonstration videos\n\nSample management solutions + LIMS\n\n\n\n\nBroughton Software Ltd.\n\nLabHQ\n\nYes\n\nUnited Kingdom\n\nPricing and demonstration videos\n\nWas formerly SkySource Ltd.\n\n\n\n\nBruker Corporation\n\nSampleTrack\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nBTLIMS Technologies\n\nBTLIMS, Lab Data Master\n\nNo\n\nUnited States\n\n\n\n\n\n \n\n\nBureau Conseils et Services SCRL\n\nAQ Manager LIMS\n\nYes\n\nBelgium\n\nPricing and demonstration videos\n\n\n\n\n\n\nBytewize AB\n\nO3 LIMS, O3 LIMSXpress\n\nYes\n\nSweden\n\nPricing and demonstration videos\n\n\n\n\n\n\nCaliber Technologies Pvt. Ltd.\n\nCaliberLIMS\n\nYes\n\nIndia\n\n\n\n\n\n\n\n\nCannabliss New England, LLC\n\nCannabLIS\n\nYes\n\nUnited States\n\n\n\nCannabis LIMS\n\n \n\n\nCapstone Technology Corporation\n\ndataPARC\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nCerebrum Corporation\n\nLABdivus\n\nYes\n\nUnited States\n\n\n\n\n\n \n\n\nCargotrader, Inc.\n\nCargotester.com\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nCarobar Business Solutions, LLC\n\nreLIMS\n\nYes\n\nUnited States\n\n\n\n\n\n \n\n\nCC Software, LLC\n\nConfident Cannabis LIMS\n\nNo\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nCellPort Software, LLC\n\nCellPort Cell Culture Suite\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n \n\n\nClinical Systems Ltd.\n\nClinAxys II\n\nNo\n\nUnited Kingdom\n\n\n\n\n\n\n\n\nCliniSys Group Limited\n\nClinisys WinPath\n\nNo\n\nUnited Kingdom\n\n\n\nPart of the Clinisys brand of companies.\n\n\n\n\nClinisys NV\n\nClinisys GLIMS, GLIMS Genetics, and DaVinci\n\nNo\n\nBelgium\n\n\n\nWas MIPS NV until September 2022.[8][9]\r\nPart of the Clinisys brand of companies.\n\n \n\n\nCliniSys, Inc.\n\nClinisys ApolloLIMS and SQ Lab\n\nNo\n\nUnited States\n\n\n\nRenamed from Sunquest Information Systems, Inc. on May 31, 2022.[10]\r\nPart of the Clinisys brand of companies.\n\n\n\n\nCloudLIMS.com, LLC\n\nCloudLIMS, FreeLIMS\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n\n\n\nClyde Computing Ltd.\n\nQ-SYS LIMS\n\nNo\n\nUnited Kingdom\n\n\n\n\n\n\n\n\nCodon Software Private Limited\n\nCodon LIMS\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nColumbia Energy & Environmental Services, Inc.\n\nOmniLIMS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nCompuDrug International, Inc.\n\nLaboratory Manager Plus\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nComputing Solutions, Inc.\n\nLabSoft LIMS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nComsense Datasystems of Australia\n\nComLIMS\n\nNo\n\nAustralia\n\n\n\n\n\n\n\n\nCondition Monitoring International, LLC\n\nLabTrak\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nContec Group International Ltd.\n\nMADCAP\n\nYes\n\nNew Zealand\n\n\n\n\n\n\n\n\nCosine Consultants Ltd.\n\nFission LIMS\n\nNo\n\nCyprus\n\n\n\n\n\n\n\n\nCSMS Sp. z o.o.\n\nCS-17 LIMS\n\nNo\n\nPoland\n\n\n\n\n\n\n\n\nDassault Syst\u00e8mes SA\n\nBIOVIA Lab Management\n\nNo\n\nFrance\n\nDemonstration videos\n\nDassault acquired Accelrys, Inc. on April 29, 2014.[11]\n\n\n\n\nData Systems Integration Group, Inc.\n\nRevolutionDx\n\nYes\n\nUnited States\n\n\n\n\n\n \n\n\nData Unlimited International, Inc.\n\nStarfruit GeneTell, IdentiTrack, and Toxicology\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nDatamine Software Ltd.\n\nCCLAS EL and CCLAS 6\n\nYes\n\nUnited Kingdom\n\nDemonstration videos\n\n\n\n\n\n\nDataworks Development, Inc.\n\nFreezerworks\n\nNo\n\nUnited States\n\nDemonstration videos\n\n\n\n \n\n\nDedalus Healthcare Ltd.\n\nDedalus LIMS\n\nYes\n\nUnited Kingdom\n\n\n\nPathology LIMS\n\n\n\n\nDeutsche Telekom Healthcare Solutions Netherlands B.V.\n\nLMS, SymPathy Lifecare\n\nNo\n\nNetherlands\n\n\n\nAcquired Finalist Software Noord Nederland C.V.\r\nand LMS in January 2019.[12][13]\n\n\n\n\nDHC Dr. Herterich & Consultants GmbH\n\nSAP QM\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\ndialog EDV Systementwicklung GmbH\n\ndiaLIMS\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nDiData, Inc.\n\nDi-LIMS\n\nNo\n\nSwitzerland\n\n\n\n\n\n \n\n\nDIPOLE SARL\n\nDipLABO\n\nNo\n\nFrance\n\n\n\n\n\n \n\n\nDiversity Arrays Technology Pty. Ltd.\n\nDArT LIMS\n\nNo\n\nAustralia\n\nDemonstration videos\n\n\n\n \n\n\nDorner GmbH & Co. KG\n\nB\/Lab, i\/med Genetics, i\/med Hygiene,\r\nM\/Lab, X\/Lab\n\nNo\n\nGermany\n\n\n\n\n\n \n\n\nDrishti-Soft Solutions Pvt. Ltd.\n\ncLIMS\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nDynamic Databases, LLC\n\nlimsExpress\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nE-BiOnary Technologies Pvt. Ltd.\n\ne-BiOnary A, C, M, and D\n\nYes\n\nIndia\n\nDemonstration videos\n\n\n\n\n\n\nEffiChem s.r.o.\n\nEffiChem\n\nYes\n\nCzech Republic\n\nDemonstration videos\n\n\n\n\n\n\nElysia-raytest GmbH\n\nArgus RPS, SARA\n\nNo\n\nGermany\n\n\n\nSpecializes in radiopharmaceutical LIMS.\n\n\n\n\nElmTree Systems, LLC\n\nElmTree System\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nElmwood Solutions, Inc.\n\nPure Harvest\n\nYes\n\nUnited States\n\n\n\nLIMS-like seed lab software\n\n \n\n\nEnable IT Solutions Pvt. Ltd.\n\nEns\u014d-LIMS\n\nNo\n\nIndia\n\nDemonstration videos\n\n\n\n\n\n\nentimo AG\n\nPhaLIMS\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nEthoSoft, Inc.\n\nX-LIMS\n\nNo\n\nUnited States\n\nPricing\n\n\n\n\n\n\nEusoft Srl\n\nEuSoft.Lab\n\nYes\n\nItaly\n\nDemonstration videos\n\n\n\n\n\n\nFink & Partner GmbH\n\n[FP]-LIMS\n\nNo\n\nGermany\n\nDemonstration videos\n\nFormer product was [Dia]\n\n\n\n\nForney, LP\n\nForneyVault\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n \n\n\nFrontier Science & Technology Research Foundation, Inc.\n\nLDMS\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nFuture Technologies, Inc.\n\nDNA LIMS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nGenesis MicroSystems, Inc.\n\nLAB-2000\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nGenetic Technologies, Inc.\n\neDNA LIMS\n\nNo\n\nUnited States\n\nPricing\n\n\n\n\n\n\nGenetrics, Inc.\n\nGEN-LIMS\n\nNo\n\nUnited Arab Emirates\n\n\n\n\n\n\n\n\nGenial Genetic Solutions, Ltd.\n\niGene, Shire\n\nNo\n\nUnited Kingdom\n\n\n\n\n\n \n\n\nGenoFAB, Inc.\n\nGenoFAB\n\nYes\n\nUnited States\n\nPricing\n\nCombination LIMS + ELN\n\n \n\n\nGenosity, Inc.\n\nIntegrated Genomic Toolkit\n\nYes\n\nUnited States\n\n\n\nGenomics platform with a LIMS\n\n \n\n\nGoInformatics, Inc.\n\nGoLIMS\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n \n\n\nGoMeyra Corporation\n\nGoMeyra LIMS\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n \n\n\nGQM mbH\n\nQualifax LIMS\n\nNo\n\nGermany\n\n\n\n\n\n \n\n\nGTS Systems Private Limited\n\nGLab360, LabExpress\n\nYes\n\nEgypt\n\n\n\n\n\n\n\n\nH&A Scientific, Inc.\n\nSLIM\n\nNo\n\nUnited States\n\nScreenshots\n\n\n\n\n\n\nHach Company\n\nHach WIMS\n\nYes\n\nUnited States, Germany\n\nDemonstration videos\n\n\n\n \n\n\nHarris Systems USA, Inc.\n\nForensic Advantage\n\nYes\n\nUnited States\n\n\n\nPlaced under Harris' Caliber Public Safety division.[14]\n\n \n\n\nHM-Software\n\nHM-LAB\n\nNo\n\nGermany\n\n\n\n\n\n \n\n\ni2D Solution, Inc.\n\ni2DS LIMS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\niCD System GmbH\n\nLABS\/Q, LABS\/QM\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nIllumina, Inc.\n\nBaseSpace Clarity LIMS, Illumina LIMS\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nIn-QM-Team Software GmbH\n\nWinLaisy\n\nNo\n\nEurope\n\n\n\nDevelopment taken over from inray Industriesoftware GmbH\r\nin March 2019.[15]\n\n\n\n\nIndusoft OOO\n\nI-LDS LIMS\n\nNo\n\nRussia\n\nDemonstration videos\n\n\n\n\n\n\nInfomed Kouvatsos Theodoros Ltd.\n\nLab@link\n\nNo\n\nGreece\n\n\n\n\n\n\n\n\nInformation Management Services, Inc.\n\nBSI, SEER*DMS\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n\n\n\nInfoTrak Pty. Ltd.\n\nOil Commander\n\nNo\n\nAustralia\n\n\n\nPrevious product name was InfoTrak Oil.\n\n\n\n\nInnovatics Ky\n\nInnoLIMS\n\nYes\n\nFinland\n\n\n\n\n\n\n\n\nInstem LSS Limited\n\nProvantis\n\nYes\n\nUnited Kingdom\n\n\n\n\n\n\n\n\nInstrumentos Cient\u00edficos SA\n\nNevisLIMS\n\nYes\n\nSpain\n\nDemonstration videos\n\n\n\n\n\n\nIntaForensics Ltd.\n\nLima Forensic Case Management\n\nNo\n\nUnited Kingdom\n\nPricing and demonstration videos\n\nPersonal edition is free, but no other pricing.\n\n\n\n\n\nIntegrated Software Solutions Ltd.\n\nOMNI-Lab\n\nNo\n\nAustralia\n\n\n\nAbsorbed Point of Care Solutions Pty. Ltd. and v-Lab in 2020.[16]\n\n \n\n\nINTEGRIS LIMS GmbH\n\niLIMS\n\nNo\n\nGermany\n\nPricing and demonstration videos\n\nChanged company name from CSS LIMS GmbH in March 2017.[17]\n\n\n\n\nInteractive Software Limited\n\nAchiever Medical LIMS\n\nYes\n\nUnited Kingdom\n\n\n\n\n\n \n\n\nInteractive Technology Services, LLC\n\nLIMS IAL\n\nYes\n\nUnited States\n\n\n\n\n\n \n\n\nInterpec Corporation\n\nINQAS, INTRACES\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nInterSystems Corporation\n\nTrakCare Lab\n\nNo\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nInVita Healthcare Technologies, Inc.\n\nSTACS Casework, STACS Database\n\nYes\n\nUnited States\n\n\n\nAcquired from STaCS DNA Inc. in May 2021.[18]\n\n \n\n\niVention BV\n\niVentionLES\n\nYes\n\nNetherlands\n\nDemonstration videos\n\nMarketed as a laboratory execution system with LIMS,\r\nELN, and SDMS functionality\n\n\n\n\nJ Street Technology, Inc.\n\nJ Street LIMS\n\nNo\n\nUnited States\n\nPricing\n\nFormerly MSC-LIMS by Mountain States Consulting, LLC.\n\n \n\n\nJeganee Technologies Pvt. Ltd.\n\nLaboratory-On\n\nYes\n\nIndia\n\n\n\n\n\n\n\n\nJusticeTrax, Inc.\n\nLIMS-plus\n\nNo\n\nUnited States\n\nPricing\n\n\n\n\n\n\njwConsulting GmbH\n\njwLIMS\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nKhemia Software, Inc.\n\nOmega 11 LIMS\n\nNo\n\nUnited States\n\nScreenshots\n\n\n\n\n\n\nKriti Microsystems Pvt. Ltd.\n\nKriti LIMS\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nKVANT spol. s r.o.\n\nEvidence\n\nNo\n\nSlovakia\n\n\n\n\n\n\n\n\nL7 Informatics, Inc.\n\nL7 ESP\n\nNo\n\nUnited States\n\nDemonstration videos\n\nEnterprise science platform\/workflow engine w\/ a LIMS\n\n\n\n\nLabCloud, Inc.\n\nLabCloud\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nLabforward GmbH\n\nLabregister\n\nYes\n\nGermany\n\n\n\nIntegrates with company's ELN Labfolder\n\n \n\n\nLabii, Inc.\n\nLabii ELN & LIMS\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\nCombination ELN + LIMS\n\n\n\n\nLabKey Corporation\n\nLabKey Biologics LIMS\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n\n\n\nLabLite, LLC\n\nLabLite SQL LIMS\n\nNo\n\nUnited States\n\nPricing\n\n\n\n\n\n\nLabLogic Systems Limited\n\nDebra, PETra\n\nNo\n\nUnited Kingdom\n\nDemonstration videos\n\n\n\n\n\n\nLabLynx, Inc.\n\nELab\n\nYes\n\nUnited States\n\nPricing and Demonstration videos\n\n\n\n\n\n\nLabMaster.pl Sp. z o.o.\n\nLabMaster LIMS\n\nYes\n\nPoland\n\n\n\n\n\n\n\n\nLabmin (Pty) Ltd.\n\nLabmin, Labmin Lite\n\nYes\n\nSouth Africa\n\nDemonstration videos\n\n\n\n \n\n\nLabPro 2000 Ltd.\n\neQual\n\nYes\n\nNew Zealand\n\n\n\n\n\n\n\n\nLabs Division SL\n\nOraLims 2000i and 3.0\n\nYes\n\nSpain\n\nDemonstration videos\n\n\n\n\n\n\nLabsoft Tecnologia Ltda.\n\nmyLIMS\n\nYes\n\nBrazil\n\nDemonstration videos\n\nNot to be confused with Odysis SA's myLIMS product.\n\n\n\n\nLabstudio (Pty) Ltd.\n\nLabstud.io LIMS\n\nYes\n\nSouth Africa\n\nPricing and screenshots\n\n\n\n \n\n\nLABTrack, LLC\n\nLABTrack LIMS\n\nYes\n\nUnited States\n\n\n\nEKM Corporation was previously a distributor of LABTrack.\n\n\n\n\nLabVantage Solutions, Inc.\n\nLabVantage 8\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\nProducts formerly called SAPPHIRE and SQL*LIMS.\n\n\n\n\nLabWare, Inc.\n\nLabWare LIMS, LabWare GROW\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n\n\n\nLabworks, LLC\n\nLabworks\n\nNo\n\nUnited States\n\n\n\nBought LABWORKS from PerkinElmer Inc. in May 2016.[19]\n\n\n\n\nLenava Engineering Group Ltd.\n\nLenava LIMS\n\nYes\n\nUnited Kingdom\n\n\n\n\n\n \n\n\nLETEC SARL\n\nTetraed LIMS\n\nNo\n\nFrance\n\n\n\n\n\n\n\n\nLex Software Solutions\n\nManage!\n\nYes (customer request)\n\nTurkey\n\nScreenshots\n\n\n\n\n\n\nLGC Limited\n\nKraken\n\nNo\n\nUnited Kingdom\n\n\n\n\n\n\n\n\nLIMS at work GmbH\n\nLabmatica LIMS\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nlims+WARE\n\nlims+WARE\/ASP, \/Networks,\r\n\/Results, \/UNIX\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nLimseo SARL\n\nSolution Laboratoire\n\nNo\n\nFrance\n\n\n\n\n\n\n\n\nLIMSey, LLC\n\nLIMSey\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nLocasoft SARL\n\nLIMS.FR\n\nYes\n\nFrance\n\nDemonstration videos\n\nProduct changed names in 2019 from Lims.net to LIMS.FR.\n\n\n\n\nLogiq Innovations, Inc.\n\nLabPlus\n\nNo\n\nCanada\n\n\n\nLabPlus formerly a product of LabPlus Technologies.\n\n\n\n\nLogicaSoft SPRL\n\nOdoo LIMS\n\nYes\n\nBelgium\n\n\n\nA LIMS built on open-source Odoo ERP\n\n \n\n\nLTech Australia Pty. Ltd.\n\nLims1\n\nNo\n\nAustralia\n\n\n\n\n\n\n\n\nLyons Information Systems, Inc.\n\nLLMS\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nM-Tech International, Inc.\n\nCAT2 LIMS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nMalvern Panalytical BV\n\nSPARCS\n\nNo\n\nNetherlands\n\n\n\nPreviously known as PANalytical BV.\n\n\n\n\nMAQSIMA GmbH\n\nMAQSIMA LAB+\n\nNo\n\nGermany\n\n\n\n\n\n \n\n\nMci IT Pty. Ltd.\n\nCloud Solutions Suite\n\nYes\n\nSouth Africa\n\nPricing and demonstration videos\n\n\n\n\n\n\nMEDEORA GmbH\n\nBioArchive\n\nYes\n\nGermany\n\nPricing and demonstration videos\n\nBiobanking LIMS\n\n \n\n\nMedpace, Inc.\n\nClinTrak Lab\n\nNo\n\nUnited States\n\n\n\nClinical research LIMS\n\n\n\n\nMegaware, Inc.\n\nLIAS\n\nNo\n\nUnited States\n\n\n\n\n\n \n\n\nMethodiq, LLC\n\ncustom LIMS development\n\nNo\n\nUnited States\n\n\n\n\n\n \n\n\nMicrocline Projects\n\nLabosaurus\n\nYes\n\nCanada\n\nPricing\n\n\n\n\n\n\nML Consulting Technologies, LLC\n\nWeLIMS\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\nFree quality control LIMS for small labs\n\n \n\n\nModul-Bio SAS\n\nMBioLIMS\n\nNo\n\nFrance\n\n\n\n\n\n\n\n\nMotto Systems Pvt. Ltd.\n\nGMPPro LIMS\n\nYes\n\nIndia\n\nDemonstration videos\n\n\n\n \n\n\nMukon Informatics (Pty) Ltd.\n\nSkylims\n\nNo\n\nSouth Africa\n\n\n\nFormerly Mukon CC. LIS marketed as a LIMS.\n\n\n\n\nMyfab\n\nMyfab LIMS\n\nNo\n\nSweden\n\n\n\n\n\n\n\n\nNational Agribusiness Technology Center\n\nUSALIMS\n\nNo\n\nUnited States\n\nPricing\n\n\n\n\n\n\nNational Cancer Institute\n\ncaLIMS\n\nNo\n\nUnited States\n\nPricing\n\n\n\n\n\n\nNexactly AI Solutions Pvt. Ltd.\n\nNexactly LIMS\n\nNo\n\nIndia\n\n\n\n\n\n \n\n\nNexix, Inc.\n\nNexix LIMS\n\nYes\n\nCanada\n\n\n\nDesigned for PCR\n\n \n\n\nNippon Control System Corporation\n\nSimpDoc\n\nNo\n\nJapan\n\n\n\nDiscontinued SimpLabo in May or June 2018.\r\nStill offering SimpDoc, per company.\n\n\n\n\nNovatek International\n\nNOVA-LIMS\n\nNo\n\nCanada\n\n\n\n\n\n\n\n\nOasis Infotech Pvt. Ltd.\n\nEnviroLIMS EWM, LIMZ-RD,\r\nOasisLIMS, True-LIMZ CTL\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nOcimum Biosolutions Ltd.\n\nBiotracker LIMS\n\nYes\n\nIndia\n\n\n\n\n\n\n\n\nOdysis SA\n\nmyLIMS\n\nNo\n\nSwitzerland\n\n\n\nNot to be confused with Labsoft Tecnologia Limitada's myLIMS product.\n\n\n\n\nOnline LIMS Canada Limited\n\nOnLIMS\n\nNo\n\nCanada\n\n\n\n\n\n\n\n\nOnQ Software Pty. Ltd.\n\nQLIMS\n\nYes\n\nAustralia\n\n\n\n\n\n\n\n\nOpen-source software solution\n\nBika LIMS\n\nN\/A\n\nN\/A\n\n\n\nSee Bika Lab Systems (Pty) Ltd. for more info.\n\n\n\n\nOpen-source software solution\n\ncaLIMS\n\nN\/A\n\nN\/A\n\n\n\nSee National Cancer Institute for more info.\n\n\n\n\nOpen-source software solution\n\nClinViro\n\nN\/A\n\nN\/A\n\n\n\nMore information found on [project page].\n\n\n\n\nOpen-source software solution\n\nGNomEx\n\nN\/A\n\nN\/A\n\n\n\nMore information found on SourceForge.net.\n\n\n\n\nOpen-source software solution\n\nGNU LIMS\n\nN\/A\n\nN\/A\n\n\n\nMore information found on the project page.\n\n\n\n\nOpen-source software solution\n\nLAMA\n\nN\/A\n\nN\/A\n\n\n\nMore information found on the project website.\n\n\n\n\nOpen-source software solution\n\nLeaf LIMS\n\nN\/A\n\nN\/A\n\n\n\nMore information found on the project website.\n\n\n\n\nOpen-source software solution\n\nMetaLIMS\n\nN\/A\n\nN\/A\n\n\n\nMore information found on the project website.\n\n\n\n\nOpen-source software solution\n\nOpen-LIMS\n\nN\/A\n\nN\/A\n\n\n\nMore information found on the project website.\n\n\n\n\nOpen-source software solution\n\nopenBIS\n\nN\/A\n\nN\/A\n\n\n\nMore information found on the project website.\n\n\n\n\nOpen-source software solution\n\nOpenELIS\n\nN\/A\n\nN\/A\n\n\n\nMore information found on the project website.\n\n\n\n\nOpen-source software solution\n\nOpenSpecimen\n\nN\/A\n\nN\/A\n\n\n\nMore information found on the Krishagni Solutions Pvt. Ltd. page.\n\n\n\n\nOpen-source software solution\n\nScreensaver HTS LIMS\n\nN\/A\n\nN\/A\n\n\n\nMore information found on SourceForge.net.\n\n\n\n\nOpen-source software solution\n\nSMITH\n\nN\/A\n\nN\/A\n\n\n\nMore information found on Bitbucket.\n\n\n\n\nOpen.Co Srl\n\nProLab.Q\n\nYes\n\nItaly\n\n\n\n\n\n\n\n\nOPTIMAL SYSTEMS GmbH\n\nenaio Laboratory Content Center\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nOracle Corporation\n\nOracle Health Sciences\r\nClinical Development Analytics\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nOrsyx\n\neL@b\n\nNo\n\nIsrael\n\nDemonstration videos\n\n\n\n\n\n\nOvation.io, Inc.\n\nOvation LIMS\n\nYes\n\nUnited States\n\nDemonstration videos\n\nCompany and product have undergone many name changes,\r\nwith \"Ovation\" the latest.\n\n \n\n\nOy Fision Ltd.\n\nBroadsight LIMS\n\nNo\n\nFinland\n\n\n\n\n\n\n\n\nPardus d.o.o.\n\neQMS::LIMS\n\nNo\n\nCroatia\n\n\n\n\n\n\n\n\nPDS Group Holding AG\n\nAscentos\n\nYes\n\nSwitzerland\n\n\n\nFormer products were PathData, ReproData, and ToxData.\n\n\n\n\npdv-software GmbH\n\npdv-lims 3\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nPersistent Systems Ltd.\n\nChemLMS\n\nNo\n\nIndia\n\n\n\nAcquired from Agilent.[20]\n\n\n\n\nPharmaceuticals Systems International, LLC\n\nPSI\n\nYes\n\nU.S.\n\nPricing and demonstration videos\n\nCloud-based application suite that includes LIMS\n\n\n\n\nPhylum SARL\n\nPhylum.Laboratoire\n\nNo\n\nFrance\n\n\n\n\n\n\n\n\nPiControl Solutions, LLC\n\nPiLims\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nPolisystem Informatica Srl\n\nAnalisi\n\nNo\n\nItaly\n\n\n\n\n\n \n\n\nPondpol Group\n\nThe rapid family of LIMS\n\nNo\n\nThailand\n\n\n\nFive LIMS-like solutions covering multiple industries\n\n\n\n\nPorter Lee Corporation\n\nCrime Fighter BEAST\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nProcess Solutions Canada Limited\n\nLDMS\n\nNo\n\nCanada\n\n\n\n\n\n\n\n\nProg4biz Software Solutions Ltd.\n\nBookitLab\n\nYes\n\nCanada\n\n\n\n\n\n\n\n\nProgeny Genetics, LLC\n\nProgeny Clinical\n\nYes\n\nUnited States\n\nPricing\n\nSome pricing available for Clinical.\n\n\n\n\nPromadis Pty. Ltd.\n\nCaseman\n\nNo\n\nAustralia\n\n\n\n\n\n\n\n\nPromium, LLC\n\nElement LIMS\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n \n\n\nPRYM-SOFT Sp. z o.o.\n\nCleverLAB, PureLAB\n\nYes\n\nPoland\n\n\n\n\n\n \n\n\nPT Digita Scientia Indonesia\n\nOrbitaLIMS\n\nNo\n\nIndonesia\n\n\n\n\n\n \n\n\nQBench, Inc.\n\nQBench\n\nYes\n\nUnited States\n\nDemonstration videos\n\nTransferred from Junction Concepts, Inc. in August 2022.\r\n(Source: Personal correspondence)\n\n \n\n\nQDA SOLUTIONS GmbH\n\nQDA LIMS\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nQualitype GmbH\n\nAbetter LIMS\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nQUALIMS SARL\n\nQUALIMS\n\nNo\n\nFrance\n\n\n\n\n\n\n\n\nQuality Systems International Corporation\n\nWinLIMS\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nQuartz Imaging Corporation\n\nQuartz LA-, FA-, and RE-LIMS\n\nNo\n\nCanada\n\n\n\n\n\n\n\n\nRaddec International Ltd.\n\nRaddec-LIMS\n\nNo\n\nUnited Kingdom\n\nDemonstration videos\n\n\n\n\n\n\nRealistic Computing, Inc.\n\neData Specialty LIMS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nReston Stable Isotope Laboratory\n\nLIMS for Lasers,\r\nLIMS for Light Stable Isotopes\n\nNo\n\nUnited States\n\nPricing\n\nThe RSIL is part of the U.S. Geological Survey.\n\n \n\n\nRevol Software Solutions, LLC\n\nRevol LIMS\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n \n\n\nRHAPSODY Software Solutions GmbH\n\nRHAPSODY LIMS\n\nNo\n\nGermany\n\n\n\nOfficially changed name from Softwaresysteme Keeve GmbH in February 2018.[21][22]\n\n\n\n\nRJ Lee Solutions, LLC\n\nTHEMIS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nRockStep Solutions, Inc.\n\nClimb\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n \n\n\nS.G. Systems, LLC\n\nV5 Traceability\n\nNo\n\nUnited States\n\n\n\nManufacturing traceability software system with a LIMS module\n\n \n\n\nSapio Sciences, LLC\n\nSapio Bioanalytical LIMS, Clinical\r\nLIMS, Histopathology LIMS, NGS LIMS,\r\nResearch LIMS, and Stability LIMS\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nSatya Sistemas Ltda.\n\nFlux2\n\nNo\n\nBrazil\n\n\n\n\n\n \n\n\nScigilian Software, Inc.\n\nScigilian\n\nYes\n\nUnited States\n\n\n\n\n\n \n\n\nScienTek Software, Inc.\n\niStability LIMS\n\nNo\n\nUnited States\n\n\n\nLIMS designed for pharmaceutical stability testing programs\r\nand stability test management\n\n\n\n\nSemaphore Solutions, Inc.\n\nLabbit, custom LIMS development\n\nNo\n\nCanada\n\n\n\n\n\n \n\n\nSempai Consulting Ltd. & Co. KG\n\nscarabPLUS\n\nNo\n\nGermany\n\n\n\nA pharmaceutical ERP that fully integrates a LIMS\n\n\n\n\nShimadzu Corporation\n\nLIMSsolution\n\nNo\n\nJapan\n\n\n\n\n\n\n\n\nSiemens AG\n\nFormulated Product Design, SIMATIC IT Unilab\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nSigmen Technologies Solutions Pvt. Ltd.\n\nSigma LIMS\n\nNo\n\nIndia\n\n\n\n\n\n \n\n\nSimploud Limited\n\nSimplab\n\nNo\n\nIsrael\n\nPricing and demonstration videos\n\nSalesforce-based LIMS\n\n \n\n\nSLCLAB Inform\u00e1tica SL\n\nALFA21, Zendo LIMS\n\nYes\n\nSpain\n\nPricing and demonstration videos\n\n\n\n \n\n\nSofcom (Private) Limited\n\nSpectrum\n\nNo\n\nPakistan\n\n\n\n\n\n \n\n\nSoft Computer Consultants, Inc.\n\nSoftLIMS\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nSoftware for Life Sciences BV\n\nLabScores\n\nNo\n\nNetherlands\n\nDemonstration videos\n\n\n\n\n\n\nSoftware Point Oy\n\nLabVantage Medical Suite,\r\nEnterprise, and Express\n\nYes\n\nFinland\n\n\n\nAcquired by LABVANTAGE in April 2011.[23] C5 LIMS was renamed to\r\n\"LABVANTAGE Medical Suite\" in December 2012.[24] Former products:\r\n TasteBOSS and WilabLIMS\n\n\n\n\nSorenson Forensics, LLC\n\neDNA LIMS\n\nNo\n\nUnited States\n\n\n\nForensic LIMS\n\n \n\n\nSpecPage AG\n\nSpecLIMS\n\nNo\n\nSwitzerland\n\n\n\nPreviously known as Object Solutions Software AG.[25][26]\n\n\n\n\nSpectra QEST Australia Pty. Ltd.\n\nQESTField, QESTLab\n\nNo\n\nAustralia\n\n\n\n\n\n\n\n\nStackWave, LLC\n\nStackWave Affinity LIMS\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nStanford University School of Medicine\n\nMendeLIMS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nSTARLIMS Corporation\n\nSTARLIMS\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\nFormerly Abbot Informatics Corporation.\n\n \n\n\nStelsel Software Technologies Pvt. Ltd.\n\nNABL LIMS\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nTechWare Incorporated\n\nLogbook Discovery,\r\nTechWare MainTrac\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nTelesphorus Consulting Ltd.\n\ngemLIMS\n\nYes\n\nUnited Kingdom\n\n\n\n\n\n \n\n\nThe Edge Software Consultancy Ltd.\n\nBioRails LIMS\n\nYes\n\nUnited Kingdom\n\nPricing and demonstration videos\n\n\n\n\n\n\nThermo Fisher Scientific\n\nCore LIMS, Nautilus, SampleManager, Watson\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nThird Wave Analytics, Inc.\n\nLockbox LIMS\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n \n\n\nTitle21 Health Solutions, Inc.\n\nCellular Therapy Solution\n\nNo\n\nUnited States\n\nDemonstration videos\n\nA LIMS with a focus on cellular therapy\n\n \n\n\nTrace First Ltd.\n\nCoreOne for Labs\n\nYes\n\nIreland\n\n\n\n\n\n\n\n\nTraxStar Technologies, Inc.\n\nQATrax LIMS\n\nNo\n\nUnited States\n\nDemonstration videos\n\n\n\n \n\n\nTribal Software, Inc.\n\nLIMS Lyte, Tribal-LIMS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nTriestram & Partner GmbH\n\nlisa.lims\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nTrilogy Group Limited\n\nTAPS\n\nNo\n\nUnited Kingdom\n\n\n\n\n\n\n\n\nTRUST Infotech Electronics, LLC\n\nTRUST LIMS\n\nNo\n\nUnited Arab Emirates\n\n\n\n\n\n \n\n\nTQ Technology Pvt. Ltd.\n\nTQLIMS\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nUncountable, Inc.\n\nUncountable\n\nYes\n\nUnited States\n\nDemonstration videos\n\nLIMS- and ELN-like platform for chemical R&D\n\n \n\n\n\nU.S. EPA\n\nScribe\n\nNo\n\nUnited States\n\nPricing\n\n\n\n\n\n\nup to data sales and services GmbH\n\nup2Lims\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nValdata Systems USA, Inc.\n\nChemical Management System\n\nYes\n\nUnited States\n\nDemonstration videos\n\nSuite of modules, including a LIMS, for manufacturing\n\n \n\n\nVeeva Systems, Inc.\n\nVault LIMS\n\nYes\n\nUnited States\n\n\n\n\n\n \n\n\nVenture Development, LLC\n\nGoRev\n\nYes\n\nUnited States\n\n\n\nHealth information system with LIMS\/LIS\n\n\n\n\nVerisis A.S.\n\nCLIMS\n\nNo\n\nTurkey\n\n\n\nForensic LIMS\n\n \n\n\nVertiQ Software, LLC\n\nCME-LIMS\n\nNo\n\nUnited States\n\n\n\nForensic LIMS\n\n\n\n\nVette EDV-Beratung & Entwicklung GmbH\n\nTransGraph\n\nNo\n\nGermany\n\n\n\nQuality management software with a LIMS module\n\n\n\n\nWaters Corporation\n\nNuGenesis 8\n\nNo\n\nUnited States\n\nPricing and demonstration videos\n\nNuGenesis 8 is a data management and workflow package\r\nof applications, including NuGenesis Sample Management.[27]\n\n\n\n\nWavefront Software, Inc.\n\nWavefront LIMS\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nWESTcom Logiciels et Services SARL\n\nARES\n\nNo\n\nFrance\n\n\n\n\n\n\n\n\nWireWorks West, Inc.\n\nFermWorks\n\nNo\n\nUnited States\n\n\n\nFormerly operated as Jova Solutions Inc.\n\n\n\n\nWixon and Cross, LLC\n\nLIMFinite\n\nYes\n\nUnited States\n\n\n\n\n\n \n\n\nWolfe Information Systems, Inc.\n\nWolfe LIMS\n\nNo\n\nUnited States\n\nPricing\n\n\n\n \n\n\nXybion Corporation\n\nLabwise XD, Pristima XD\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\nPre-clinical LIMS solutions\n\n\n\n\nYokogawa Electric Corporation\n\nOpreX, CIMVisionLIMS\n\nNo\n\nJapan\n\n\n\n\n\n\n\n\nYro Systems Pvt. Ltd.\n\nMocDoc LIMS\n\nNo\n\nIndia\n\n\n\n\n\n \n\n\nYullin Technologies Co., Ltd.\n\nLabMate Enterprise\n\nNo\n\nSouth Korea\n\n\n\n\n\n\n\nReferences \n\n\n\u2191 \"Datamine Acquires Intelligent Mining Solutions (IMS)\". Datamine Software Ltd. 27 August 2019. http:\/\/www.dataminesoftware.com\/2019\/08\/27\/datamine-acquires-ims\/ . Retrieved 28 September 2019 .   \n \n\n\u2191 \"Agilent Technologies Completes Asset Acquisition of iLab Solutions, a Leader in Cloud-Based Laboratory Management Software\". Agilent Technologies, Inc. 1 August 2016. http:\/\/www.agilent.com\/about\/newsroom\/presrel\/2016\/01aug-gp16015.html . Retrieved 20 April 2017 .   \n \n\n\u2191 Barraud, E. (2 May 2018). \"US group Agilent enters EPFL Innovation Park by acquiring Genohm\". EPFL News. \u00c9cole polytechnique f\u00e9d\u00e9rale de Lausanne. https:\/\/actu.epfl.ch\/news\/us-group-agilent-enters-epfl-innovation-park-by-ac\/ . Retrieved 15 May 2018 .   \n \n\n\u2191 \"Genohm SA closes its sale to Agilent Technologies Ltd\". Kellerhals Carrard. 14 May 2018. https:\/\/www.kellerhals-carrard.ch\/fr\/genohm-sa-closes-its-sale-to-agilent-technologies-ltd-_content---1--8--460.html . Retrieved 15 May 2018 .   \n \n\n\u2191 \"Autoscribe launches US operation\". American Laboratory. CompareNetworks, Inc. 20 March 2012. http:\/\/www.americanlaboratory.com\/Specialty\/Forensics\/617-News\/37427-Autoscribe-launches-US-operation\/ . Retrieved 19 January 2016 .   \n \n\n\u2191 Bentley Systems, Inc (13 May 2019). \"Bentley Systems Announces the Acquisition of Keynetix, Provider of Geotechnical Data Management Cloud Services\". PR Newswire. https:\/\/www.prnewswire.com\/news-releases\/bentley-systems-announces-the-acquisition-of-keynetix-provider-of-geotechnical-data-management-cloud-services-300848796.html . Retrieved 25 October 2020 .   \n \n\n\u2191 \"BioData Launches Labguru, a Collaborative Research Management Web Application for Academic Labs\". Digital Science. Macmillan Publishers Limited. 5 December 2011. Archived from the original on 10 May 2012. https:\/\/web.archive.org\/web\/20120510070908\/http:\/\/www.digital-science.com\/biodata-launches-labguru\/ . Retrieved 19 January 2016 .   \n \n\n\u2191 \"MEDICAL INFORMATION PROFESSIONAL SYSTEMS, AFGEKORT : MIPS NV\". Moniteur Belge. 9 September 2022. http:\/\/www.ejustice.just.fgov.be\/cgi_tsv\/tsv_rech.pl?language=nl&btw=0428149981&liste=Liste . Retrieved 23 January 2023 .   \n \n\n\u2191 \"Medical Information Professional System - Benaming, Statuten (Vertaling, coordinatie, overige wijzigingen)\" (PDF). Moniteur Belge. 7 September 2022. https:\/\/www.ejustice.just.fgov.be\/tsv_pdf\/2022\/09\/09\/22356749.pdf . Retrieved 23 January 2023 .   \n \n\n\u2191 \"Articles of Amendment of Sunquest Information Systems, Inc\" (PDF). Commonwealth of Pennsylvania. 31 May 2022. https:\/\/ecorp.azcc.gov\/CommonHelper\/GetFilingDocuments?barcode=22053110494530 . Retrieved 23 January 2023 .   \n \n\n\u2191 \"Dassault Syst\u00e8mes Successfully Completes Acquisition of Accelrys\". Dassault Syst\u00e8mes SA. 29 April 2014. http:\/\/www.3ds.com\/press-releases\/single\/dassault-systemes-successfully-completes-acquisition-of-accelrys\/ . Retrieved 04 September 2014 .   \n \n\n\u2191 Toet, D. (19 January 2019). \"Telekom Healthcare lijft Finalist Noord Nederland in\". Computable. https:\/\/www.computable.nl\/artikel\/nieuws\/datamanagement\/6549711\/250449\/telekom-healthcare-lijft-finalist-noord-nederland-in.html . Retrieved 17 October 2019 .   \n \n\n\u2191 \"Finalist Noord Nederland B.V. gaat verder onder de naam Deutsche Telekom Healthcare\". Finalist Software Noord Nederland C.V. http:\/\/www.finalistsoftware.com\/?id=57 . Retrieved 17 October 2019 .   \n \n\n\u2191 \"Forensic Advantage Systems has moved!\". Harris Systems USA, Inc. https:\/\/caliberpublicsafety.com\/forensic-advantage-redirect\/ . Retrieved 02 October 2021 .   \n \n\n\u2191 \"Das QM-Team nimmt die Arbeit auf und \u00fcbernimmt das LIMS WinLaisy\". MobileWorld.today. Business.today network GmbH & Co KG. 15 April 2019. http:\/\/www.mobileworld.today\/das-qm-team-nimmt-die-arbeit-auf-und-uebernimmt-das-lims-winlaisy\/ . Retrieved 15 April 2019 .   \n \n\n\u2191 \"Point of Care Solutions\". Point of Care Solutions Pty. Ltd. Archived from the original on 18 January 2020. https:\/\/web.archive.org\/web\/20200118085822\/http:\/\/www.pocsolutions.net\/ . Retrieved 06 November 2020 .   \n \n\n\u2191 \"Umfirmierung der CSS LIMS GmbH\". INTEGRIS LIMS GmbH. 2 March 2017. https:\/\/www.ilims.de\/news\/detail\/konsequente-strategie-umfirmierung-der-css-lims-gmbh\/ . Retrieved 18 October 2017 .   \n \n\n\u2191 Nobile, J. (18 May 2021). \"Riverside acquires STACS DNA for InVita platform\". Crain's. Archived from the original on 18 May 2021. https:\/\/web.archive.org\/web\/20210518230623\/https:\/\/www.crainscleveland.com\/finance\/riverside-acquires-stacs-dna-invita-platform . Retrieved 02 March 2022 .   \n \n\n\u2191 \"LABWORKS LIMS Acquired from PerkinElmer by Labworks LLC \u2013 Future Never Looked Brighter\". BusinessWire. Business Wire, Inc. 11 May 2016. http:\/\/www.businesswire.com\/news\/home\/20160511005343\/en\/LABWORKS-LIMS-Acquired-PerkinElmer-Labworks-LLC-%E2%80%93 . Retrieved 02 June 2016 .   \n \n\n\u2191 \"Persistent system to acquire french software business of Agilent Technologies\". The Economic Times. 31 May 2011. http:\/\/articles.economictimes.indiatimes.com\/2011-05-31\/news\/29604386_1_persistent-systems-life-sciences-anand-deshpande . Retrieved 10 April 2013 .   \n \n\n\u2191 \"RHAPSODY Software Solutions GmbH, Ibbenb\u00fcren\". Cylex. S.C Cylex Tehnologia Informatiei International S.N.C. https:\/\/web2.cylex.de\/firma-home\/rhapsody-software-solutions-gmbh-1447434.html . Retrieved 15 January 2019 .   \n \n\n\u2191 \"Softwaresysteme Keeve GmbH\". online-handelregister.de. Registeranzeiger GmbH. https:\/\/www.online-handelsregister.de\/handelsregisterauszug\/nw\/Steinfurt\/S\/Softwaresysteme+Keeve+GmbH\/1798127 . Retrieved 15 January 2019 .   \n \n\n\u2191 \"LABVANTAGE Acquires Long-Time Partner Software Point\". LABVANTAGE Solutions, Inc. 5 April 2011. http:\/\/www.labvantage.com\/newsroom\/index.php\/2011\/04\/labvantage-acquires-long-time-partner-software-point\/ . Retrieved 2 January 2012 .   \n \n\n\u2191 \"Software Point - News\". Software Point Oy. 21 December 2012. http:\/\/www.softwarepoint.com\/news.html . Retrieved 10 April 2013 .   \n \n\n\u2191 \"Object Solutions\". SpecPage plc. Archived from the original on 15 August 2015. https:\/\/web.archive.org\/web\/20150815162117\/https:\/\/www.objectsolutions.eu\/ . Retrieved 27 July 2016 .   \n \n\n\u2191 \"Press\". SpecPage plc. Archived from the original on 10 July 2016. https:\/\/web.archive.org\/web\/20160710173713\/https:\/\/www.specpage.com\/about-us\/press\/#002845730ff39021e . Retrieved 27 July 2016 .   \n \n\n\u2191 \"NuGenesis 8 Featuring LE Technologies\" (PDF). Waters Corporation. http:\/\/www.waters.com\/webassets\/cms\/library\/docs\/720003597en.pdf . Retrieved 20 April 2013 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 21:57.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 6 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","d1c053b2048cf912b5b8f8e81bfa051d_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Resources_for_selecting_and_implementing_informatics_solutions_LIMS_vendors rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Resources_for_selecting_and_implementing_informatics_solutions_LIMS_vendors skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Resources for selecting and implementing informatics solutions\/LIMS vendors<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"4._Resources_for_selecting_and_implementing_informatics_solutions\">4. Resources for selecting and implementing informatics solutions<\/span><\/h2>\n<p>The LIMS vendors and consultants lists are directly pulled from LIMSwiki's maintained tabular listings of these types of entities. The professional section addresses trade organizations, conferences, and more. The last section introduces LIMSpec, which will be addressed further in this guide.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"4.1_LIMS_vendors\">4.1 LIMS vendors<\/span><\/h3>\n<p>NOTE: This listing represents all known active LIMS vendors. For a categorized listing of LIMS vendors who publicly indicate they serve a particular manufacturing-related industry, see the categorization of <a href=\"https:\/\/www.limswiki.org\/index.php\/Category:LIMS_vendors_by_industry\" title=\"Category:LIMS vendors by industry\" class=\"wiki-link\" data-key=\"a2c6a5ceb8dc2aa574f7000971fb4c21\">LIMS vendors by industry<\/a>. In particular, you may want to look at LIMS vendors who specifically market a product to the <a href=\"https:\/\/www.limswiki.org\/index.php\/Category:Manufacturing_and_R%26D_LIMS\" title=\"Category:Manufacturing and R&D LIMS\" class=\"wiki-link\" data-key=\"ac6c5a41f8586ac3d0cce7ecc2a59984\">manufacturing and R&D<\/a> sector.\n<\/p><p><br \/>\n<\/p>\n<div style=\"text-align: left;\">\n<table class=\"sortable\" id=\"rdp-ebb-LIMSvendor\" border=\"1\" cellpadding=\"5\" cellspacing=\"0\" align=\"center\" style=\"\">\n<tbody><tr>\n<th>Vendor\n<\/th>\n<th>Key LIMS offering(s)\n<\/th>\n<th><a href=\"https:\/\/www.limswiki.org\/index.php\/SaaS\" class=\"mw-redirect wiki-link\" title=\"SaaS\" data-key=\"aaf75109a2977abf80eda124a5d3f7fe\">SaaS<\/a><br \/>option?\n<\/th>\n<th>Headquarters<br \/>(Country)\n<\/th>\n<th>Key information\n<\/th>\n<th>Additional notes\n<\/th><\/tr>\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/10BioSystems,_LLC\" title=\"10BioSystems, LLC\" class=\"wiki-link\" data-key=\"1a6cc3fb2f7f7a277713094e59c90b25\">10BioSystems, LLC<\/a>\n<\/td>\n<td>LabCentral\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/AAC_Infotray_AG\" title=\"AAC Infotray AG\" class=\"wiki-link\" data-key=\"4fbc615d17856b086669d1909e7bab7a\">AAC Infotray AG<\/a>\n<\/td>\n<td>Limsophy LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Switzerland\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ABB_Ltd.\" title=\"ABB Ltd.\" class=\"wiki-link\" data-key=\"b39f205310adb7bb028a4f0a6960f088\">ABB Ltd.<\/a>\n<\/td>\n<td>Knowledge Manager\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Sold CCLAS LIMS to <a href=\"https:\/\/www.limswiki.org\/index.php\/Datamine_Software_Ltd.\" title=\"Datamine Software Ltd.\" class=\"wiki-link\" data-key=\"2ec3c0c72883c746ce035593e8414a76\">Datamine Software Ltd.<\/a> in August 2019.<sup id=\"rdp-ebb-cite_ref-DSDatamine19_1-0\" class=\"reference\"><a href=\"#cite_note-DSDatamine19-1\">[1]<\/a><\/sup>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ABI-Health_Technologies_Pvt._Ltd.\" title=\"ABI-Health Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"cc078547cbe8a6154c775ae6fe85caca\">ABI-Health Technologies Pvt. Ltd.<\/a>\n<\/td>\n<td>ABI LIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>LIMS is part of the SmartLabs platform.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ABS_Systems,_Inc.\" title=\"ABS Systems, Inc.\" class=\"wiki-link\" data-key=\"ebea264dfe0fd72457d52d47c064adb8\">ABS Systems, Inc.<\/a>\n<\/td>\n<td>PHIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Adifo_NV\" title=\"Adifo NV\" class=\"wiki-link\" data-key=\"3f8b255c27b3276eea6ac4ee9e1f619e\">Adifo NV<\/a>\n<\/td>\n<td>BESTMIX LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Belgium\n<\/td>\n<td>\n<\/td>\n<td>Former product Laboras now seems defunct.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Advanced_Solutions_Accelerator_SAS\" title=\"Advanced Solutions Accelerator SAS\" class=\"wiki-link\" data-key=\"9086de029f29b6ee13f482b71a710b04\">Advanced Solutions Accelerator SAS<\/a>\n<\/td>\n<td>100 lims\n<\/td>\n<td>No\n<\/td>\n<td>France\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Advanced_Technical_Software\" title=\"Advanced Technical Software\" class=\"wiki-link\" data-key=\"6358148515edeb86587225e6cd9d802c\">Advanced Technical Software<\/a>\n<\/td>\n<td>uniLIME\n<\/td>\n<td>No\n<\/td>\n<td>Austria\n<\/td>\n<td>\n<\/td>\n<td>Former product q\/LIME seems no longer supported.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Advanced_Technology_Corp.\" title=\"Advanced Technology Corp.\" class=\"wiki-link\" data-key=\"f57bd1ff47e01118be96670e54f1ce0f\">Advanced Technology Corp.<\/a>\n<\/td>\n<td>VADDS, VETSTAR\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Agaram_Technologies_Pvt._Ltd.\" title=\"Agaram Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"da3a4846bd90a4735bd580b830ffdade\">Agaram Technologies Pvt. Ltd.<\/a>\n<\/td>\n<td>Qualis LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>India\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Agaram_Technologies_Pvt._Ltd.#Demonstration_videos_and_other_media\" title=\"Agaram Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"8886c0045a6f8ca1eae361df16c3cee9\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/AgiLab_SAS\" title=\"AgiLab SAS\" class=\"wiki-link\" data-key=\"40bb104bd6e246005a7f8d56589ba914\">AgiLab SAS<\/a>\n<\/td>\n<td>AgiLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>France\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Agile_Frameworks,_LLC\" title=\"Agile Frameworks, LLC\" class=\"wiki-link\" data-key=\"8917f2196ba414119111c1a6f8b18797\">Agile Frameworks, LLC<\/a>\n<\/td>\n<td>MetaField\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Agile_Frameworks,_LLC#Demonstration_videos_and_other_media\" title=\"Agile Frameworks, LLC\" class=\"wiki-link\" data-key=\"660c59ccfcdb2aa7e11f02f5289648fc\">Demonstration videos<\/a>\n<\/td>\n<td>A field information management system for architecture,<br \/>engineering, and construction that contains a full LIMS module\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/AgileBio\" title=\"AgileBio\" class=\"wiki-link\" data-key=\"c34addf58af91e53114eed40843f5e6e\">AgileBio<\/a>\n<\/td>\n<td>LabCollector\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/AgileBio#Pricing\" title=\"AgileBio\" class=\"wiki-link\" data-key=\"8498e8f1abbebdccf70d0f67da10967a\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/AgileBio#Demonstration_videos_and_other_media\" title=\"AgileBio\" class=\"wiki-link\" data-key=\"a1928ed9276395ad843045080dc45e32\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Agilent_Technologies,_Inc.\" title=\"Agilent Technologies, Inc.\" class=\"wiki-link\" data-key=\"dcea1a676a012bcbe3af9562dd17f8a0\">Agilent Technologies, Inc.<\/a>\n<\/td>\n<td>iLab Operations Software, SLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Agilent_Technologies,_Inc.#Demonstration_videos_and_other_media\" title=\"Agilent Technologies, Inc.\" class=\"wiki-link\" data-key=\"9225f61694fdae0fef1314b3302d107a\">Demonstration videos<\/a>\n<\/td>\n<td>Agilent acquired the iLab core facility management software in 2016.<sup id=\"rdp-ebb-cite_ref-AgilentiLabAcqComp_2-0\" class=\"reference\"><a href=\"#cite_note-AgilentiLabAcqComp-2\">[2]<\/a><\/sup><br \/>Agilent acquired <a href=\"https:\/\/www.limswiki.org\/index.php\/Genohm_SA\" title=\"Genohm SA\" class=\"wiki-link\" data-key=\"426b7038bf902fd270a107745d2b6087\">Genohm SA<\/a> in May 2018.<sup id=\"rdp-ebb-cite_ref-BarraudUSGroup18_3-0\" class=\"reference\"><a href=\"#cite_note-BarraudUSGroup18-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KCGenohm18_4-0\" class=\"reference\"><a href=\"#cite_note-KCGenohm18-4\">[4]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/AHP_GmbH\" title=\"AHP GmbH\" class=\"wiki-link\" data-key=\"e053aa17490f9e8aa325e52afaac0777\">AHP GmbH<\/a>\n<\/td>\n<td>iQ-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/AINZ_Corp.\" title=\"AINZ Corp.\" class=\"wiki-link\" data-key=\"aaa71ea6cc519f9b67c4aa80b19f093c\">AINZ Corp.<\/a>\n<\/td>\n<td>LabFlow\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/AINZ_Corp.\" title=\"AINZ Corp.\" class=\"wiki-link\" data-key=\"aaa71ea6cc519f9b67c4aa80b19f093c\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/AINZ_Corp.#Demonstration_videos_and_other_media\" title=\"AINZ Corp.\" class=\"wiki-link\" data-key=\"d8228039cf90a3fd5eaf53b30d927139\">demonstration videos<\/a>\n<\/td>\n<td>Cannabis-oriented LIMS; former product was PharmWare.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/AiZen_Algo_Pvt._Ltd.\" title=\"AiZen Algo Pvt. Ltd.\" class=\"wiki-link\" data-key=\"8bde23d6a1d0846c270c1c82a4a1cbc5\">AiZen Algo Pvt. Ltd.<\/a>\n<\/td>\n<td>LabZen\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Alcor_SPRL\" title=\"Alcor SPRL\" class=\"wiki-link\" data-key=\"a8be1c8fb1eda7c786a39166d25f3e09\">Alcor SPRL<\/a>\n<\/td>\n<td>CI-Master, LabTec\n<\/td>\n<td>No\n<\/td>\n<td>Belgium\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Alpha_Technologies_US,_LP\" title=\"Alpha Technologies US, LP\" class=\"wiki-link\" data-key=\"dac6faa3ec36fa891f4de40c101095b4\">Alpha Technologies US, LP<\/a>\n<\/td>\n<td>Enterprise\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Ambidata_Digital_Innovation_Solutions_%26_Consulting,_Lda.\" title=\"Ambidata Digital Innovation Solutions & Consulting, Lda.\" class=\"wiki-link\" data-key=\"f48953e95db4630b528ce70cd10dfefc\">Ambidata Digital Innovation Solutions & Consulting, Lda.<\/a>\n<\/td>\n<td>LabWay-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Portugal\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/American_Technical_Services,_Inc.\" title=\"American Technical Services, Inc.\" class=\"wiki-link\" data-key=\"dd6b4b95a2572ea5e24f7b22cbc9aadc\">American Technical Services, Inc.<\/a>\n<\/td>\n<td>MOX\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\"Laboratory workflow and [metrology] management system\"<br \/>with LIMS module\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Analytical_Information_Systems,_Ltd.\" title=\"Analytical Information Systems, Ltd.\" class=\"wiki-link\" data-key=\"44e22435809370a1d8d87c35b4c94d31\">Analytical Information Systems, Ltd.<\/a>\n<\/td>\n<td>AIS LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Aquatic_Informatics,_Inc.\" title=\"Aquatic Informatics, Inc.\" class=\"wiki-link\" data-key=\"24af643179a4b254ae6352b1cfa2bf38\">Aquatic Informatics, Inc.<\/a>\n<\/td>\n<td>AQUARIUS\n<\/td>\n<td>Yes\n<\/td>\n<td>Canada\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Aquatic_Informatics,_Inc.#Demonstration_videos_and_other_media\" title=\"Aquatic Informatics, Inc.\" class=\"wiki-link\" data-key=\"deb6dea046006ce6be07dd4b7ce5985a\">Demonstration videos<\/a>\n<\/td>\n<td>Not marketed as a LIMS, but software suite has<br \/>extensive LIMS functionality.\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ASM_Soft_SL\" title=\"ASM Soft SL\" class=\"wiki-link\" data-key=\"3ccb9f446afd7190be080f964b866acf\">ASM Soft SL<\/a>\n<\/td>\n<td>asmLIMS\n<\/td>\n<td>No\n<\/td>\n<td>Spain\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Assaynet_Inc.\" title=\"Assaynet Inc.\" class=\"wiki-link\" data-key=\"2f78169d45cd9ed8cbf34e76f4c6cf04\">Assaynet Inc.<\/a>\n<\/td>\n<td>Assaynet LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Canada\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Assaynet_Inc.#Demonstration_videos_and_other_media\" title=\"Assaynet Inc.\" class=\"wiki-link\" data-key=\"c8ff93c193e5a1f583313fbca5c7df53\">Demonstration videos<\/a>\n<\/td>\n<td>Previous name for LIMS2010 was LIMS2003.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Asterian,_LLC\" title=\"Asterian, LLC\" class=\"wiki-link\" data-key=\"45e09301b4990df83845279326cd2243\">Asterian, LLC<\/a>\n<\/td>\n<td>ArgoLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>See the <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_vendor\" title=\"LIS vendor\" class=\"wiki-link\" data-key=\"28459eb218e1163e19c62c819c9c4b34\">LIS vendor<\/a> page for QuikLIMS.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Asystance_B.V.\" title=\"Asystance B.V.\" class=\"wiki-link\" data-key=\"cd8cc28cfa54ed1217e43d694a71db15\">Asystance B.V.<\/a>\n<\/td>\n<td>AlisQI LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>Netherlands\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Asystance_B.V.#Demonstration_videos_and_other_media\" title=\"Asystance B.V.\" class=\"wiki-link\" data-key=\"cc3fa07589e815bf28c945dd3772b249\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ATGC_Labs,_LLC\" title=\"ATGC Labs, LLC\" class=\"wiki-link\" data-key=\"4d3fbb6b860d12285cf1423964464a6c\">ATGC Labs, LLC<\/a>\n<\/td>\n<td>ActiveLIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Aurora_Systems,_Inc.\" title=\"Aurora Systems, Inc.\" class=\"wiki-link\" data-key=\"912e78c0df153ed7d4a80c4695a6bd08\">Aurora Systems, Inc.<\/a>\n<\/td>\n<td>VisuaLab\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Autoscribe_Informatics,_Inc.\" class=\"mw-redirect wiki-link\" title=\"Autoscribe Informatics, Inc.\" data-key=\"a187eaeb93bae7889be44009f869fc9c\">Autoscribe Informatics, Inc.<\/a>\n<\/td>\n<td>Matrix Gemini, Matrix Express\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Autoscribe_Informatics,_Inc.#Pricing\" class=\"mw-redirect wiki-link\" title=\"Autoscribe Informatics, Inc.\" data-key=\"af72f1ca8e43960c66370ca2d3227947\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Autoscribe_Informatics,_Inc.#Demonstration_videos_and_other_media\" class=\"mw-redirect wiki-link\" title=\"Autoscribe Informatics, Inc.\" data-key=\"d48ffbb8e57a67a5526546949161da05\">demonstration videos<\/a>\n<\/td>\n<td>North American distributor\/support team was<br \/><a href=\"https:\/\/www.limswiki.org\/index.php\/Zumatrix,_Inc.\" title=\"Zumatrix, Inc.\" class=\"wiki-link\" data-key=\"f45acef05fe5c7eefd6df00e5857f808\">Zumatrix, Inc.<\/a> until it was absorbed into new<br \/>entity Autoscribe Informatics, Inc.<sup id=\"rdp-ebb-cite_ref-AutoZum_5-0\" class=\"reference\"><a href=\"#cite_note-AutoZum-5\">[5]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BARTELT_GmbH\" title=\"BARTELT GmbH\" class=\"wiki-link\" data-key=\"f660ab104730a431f4f979384df0718b\">BARTELT GmbH<\/a>\n<\/td>\n<td>datalabX\n<\/td>\n<td>No\n<\/td>\n<td>Austria\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bassetti_France_SAS\" title=\"Bassetti France SAS\" class=\"wiki-link\" data-key=\"cce1e3c8c69f0562c46de73e92415c07\">Bassetti France SAS<\/a>\n<\/td>\n<td>TEEXMA LIMS\n<\/td>\n<td>No\n<\/td>\n<td>France\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Batalyse_GmbH\" title=\"Batalyse GmbH\" class=\"wiki-link\" data-key=\"c20471db1bdff24325b81bff5fc4921c\">Batalyse GmbH<\/a>\n<\/td>\n<td>Mind\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Batalyse_GmbH#Demonstration_videos_and_other_media\" title=\"Batalyse GmbH\" class=\"wiki-link\" data-key=\"2efd5866507aa6519d7bc357532bdf78\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Baytek_International,_Inc.\" title=\"Baytek International, Inc.\" class=\"wiki-link\" data-key=\"92bd2781da39f29dfafa73d5f07fd530\">Baytek International, Inc.<\/a>\n<\/td>\n<td>cBLISS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Product line changed in summer 2017 with introduction of cBLISS.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Beijing_Bio-LIMS_Soft_Co._Ltd.\" title=\"Beijing Bio-LIMS Soft Co. Ltd.\" class=\"wiki-link\" data-key=\"bc35984c45722a01f3bee31996d22084\">Beijing Bio-LIMS Soft Co. Ltd.<\/a>\n<\/td>\n<td>Bio-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>China\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bentley_Systems,_Inc.\" title=\"Bentley Systems, Inc.\" class=\"wiki-link\" data-key=\"74934162295acb488791abb46a2ea826\">Bentley Systems, Inc.<\/a>\n<\/td>\n<td>KeyLAB\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bentley_Systems,_Inc.#Pricing\" title=\"Bentley Systems, Inc.\" class=\"wiki-link\" data-key=\"987d633336982a6666ade138317ecffd\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Bentley_Systems,_Inc.#Demonstration_videos_and_other_media\" title=\"Bentley Systems, Inc.\" class=\"wiki-link\" data-key=\"70aed42e7ce8b999cebda150552af5e7\">demonstration videos<\/a>\n<\/td>\n<td>Acquired <a href=\"https:\/\/www.limswiki.org\/index.php\/Keynetix_Ltd.\" title=\"Keynetix Ltd.\" class=\"wiki-link\" data-key=\"67f4c3ea43f496d5f17b152d1bfd0210\">Keynetix Ltd.<\/a> and KeyLAB in 2019.<sup id=\"rdp-ebb-cite_ref-PRNBentley19_6-0\" class=\"reference\"><a href=\"#cite_note-PRNBentley19-6\">[6]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BGASoft,_Inc.\" title=\"BGASoft, Inc.\" class=\"wiki-link\" data-key=\"ccea591e377b4c7f4680f27c773e9c8a\">BGASoft, Inc.<\/a>\n<\/td>\n<td>LIMS ABC\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bika_Lab_Systems_(Pty)_Ltd.\" title=\"Bika Lab Systems (Pty) Ltd.\" class=\"wiki-link\" data-key=\"a39862cc41349265a37eb87242d3a628\">Bika Lab Systems (Pty) Ltd.<\/a>\n<\/td>\n<td>Bika LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>South Africa\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bika_Lab_Systems_(Pty)_Ltd.#Technology_and_products\" title=\"Bika Lab Systems (Pty) Ltd.\" class=\"wiki-link\" data-key=\"0e00535956e5734b611eedfe2e4b3df3\">Pricing<\/a>\n<\/td>\n<td>Also available at <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sourceforge.net\/projects\/bika\/\" target=\"_blank\">SourceForge.net<\/a> under GPL.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bio-Analytical_Technologies_Pvt._Ltd.\" title=\"Bio-Analytical Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"a23d24d5228dcb60dd8a0fe1a8c28dea\">Bio-Analytical Technologies Pvt. Ltd.<\/a>\n<\/td>\n<td>BioClinical\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bio-ITech_BV\" title=\"Bio-ITech BV\" class=\"wiki-link\" data-key=\"0ab0bcce001863e24f1715ef1acef1ef\">Bio-ITech BV<\/a>\n<\/td>\n<td>eLABInventory, eLABJournal\n<\/td>\n<td>Yes\n<\/td>\n<td>The Netherlands\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bio-ITech_BV#Pricing\" title=\"Bio-ITech BV\" class=\"wiki-link\" data-key=\"401f725e77257661d93f0edf27e2a4d6\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Bio-ITech_BV#Demonstration_videos_and_other_media\" title=\"Bio-ITech BV\" class=\"wiki-link\" data-key=\"adc8ad4303a89c181bbc0857777ccfc7\">demonstration videos<\/a>\n<\/td>\n<td>Neither is a true traditional LIMS; Inventory is a sample manager<br \/>and Journal is an ELN with the features of Inventory. However, both<br \/>have LIMS-like features.\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BioData_Inc.\" title=\"BioData Inc.\" class=\"wiki-link\" data-key=\"0abb9920aae2ef7f78261a9d37d5573a\">BioData Inc.<\/a>\n<\/td>\n<td>Labguru\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BioData_Inc.#Demonstration_videos_and_other_media\" title=\"BioData Inc.\" class=\"wiki-link\" data-key=\"04f4fdf221f9b65d9847a25be1619c82\">Demonstration videos<\/a>\n<\/td>\n<td>Labguru replaced LabLife and BioKM on December 5, 2011.<sup id=\"rdp-ebb-cite_ref-LGLaunchArch_7-0\" class=\"reference\"><a href=\"#cite_note-LGLaunchArch-7\">[7]<\/a><\/sup><br \/>Became an ELN+LIMS platform in late 2022.\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BioFortis,_Inc.\" title=\"BioFortis, Inc.\" class=\"wiki-link\" data-key=\"b71bcfcea1af5e472d9032c5890aa1ed\">BioFortis, Inc.<\/a>\n<\/td>\n<td>Labmatrix\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BioInfoRx,_Inc.\" title=\"BioInfoRx, Inc.\" class=\"wiki-link\" data-key=\"c35df6582332a8f913b5b8b6b2e27c1a\">BioInfoRx, Inc.<\/a>\n<\/td>\n<td>mLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BioInfoRx,_Inc.#Pricing\" title=\"BioInfoRx, Inc.\" class=\"wiki-link\" data-key=\"0c6739abd5607f8eaeffc1e2382287d1\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/BioInfoRx,_Inc.#Demonstration_videos_and_other_media\" title=\"BioInfoRx, Inc.\" class=\"wiki-link\" data-key=\"5035feb3b33ecc8c4aaa186d1aeb9c07\">demonstration videos<\/a>\n<\/td>\n<td>Animal colony management LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Biomatters_Ltd.\" title=\"Biomatters Ltd.\" class=\"wiki-link\" data-key=\"506681e49f25e73e9bd31f6bbd62b506\">Biomatters Ltd.<\/a>\n<\/td>\n<td>Geneious\n<\/td>\n<td>No\n<\/td>\n<td>New Zealand\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Biomatters_Ltd.#Pricing\" title=\"Biomatters Ltd.\" class=\"wiki-link\" data-key=\"d78a451c50ebcba4e6ab6d8a7897f464\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Biomatters_Ltd.#Demonstration_videos_and_other_media\" title=\"Biomatters Ltd.\" class=\"wiki-link\" data-key=\"874fcb0bcec8c56b58335ce83658758c\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Biomed_Systems_Ltd.\" title=\"Biomed Systems Ltd.\" class=\"wiki-link\" data-key=\"e52541ec9cbe7a9c1c530f5d01ea1ef1\">Biomed Systems Ltd.<\/a>\n<\/td>\n<td>LABA\n<\/td>\n<td>Yes\n<\/td>\n<td>England\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Biomed_Systems_Ltd.#Pricing\" title=\"Biomed Systems Ltd.\" class=\"wiki-link\" data-key=\"58c4d58700df722378c5e4071ae3566a\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Biomed_Systems_Ltd.#Demonstration_videos_and_other_media\" title=\"Biomed Systems Ltd.\" class=\"wiki-link\" data-key=\"fbc00cbcbf665b9cf971643476449e28\">demonstration videos<\/a>\n<\/td>\n<td>Biotechnology and biobanking LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BioSilicium_SASU\" title=\"BioSilicium SASU\" class=\"wiki-link\" data-key=\"8adc0a729f29904286e2d4fcef0c39d5\">BioSilicium SASU<\/a>\n<\/td>\n<td>bs-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>France\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bit_Wave_Solutions_Ltd.\" title=\"Bit Wave Solutions Ltd.\" class=\"wiki-link\" data-key=\"360a058fbd05c72b34e0159ce7d2853b\">Bit Wave Solutions Ltd.<\/a>\n<\/td>\n<td>Labsols LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Blaze_Systems_Corporation\" title=\"Blaze Systems Corporation\" class=\"wiki-link\" data-key=\"fb2aea14f6811852668d37103fd9190b\">Blaze Systems Corporation<\/a>\n<\/td>\n<td>BlazeLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Blaze_Systems_Corporation#Pricing\" title=\"Blaze Systems Corporation\" class=\"wiki-link\" data-key=\"3827eb382241c2260beda7d3f84dde7e\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Blaze_Systems_Corporation#Demonstration_videos_and_other_media\" title=\"Blaze Systems Corporation\" class=\"wiki-link\" data-key=\"14b042101149f9bb467bba30fa266b56\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Blomesystem_GmbH\" title=\"Blomesystem GmbH\" class=\"wiki-link\" data-key=\"3ed88c94fa8b43cdfdd5a8b0fec66565\">Blomesystem GmbH<\/a>\n<\/td>\n<td>LABbase\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>readyLIMS appears to have been discontinued in 2019 or 2020.\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bode_Cellmark_Forensics,_Inc.\" title=\"Bode Cellmark Forensics, Inc.\" class=\"wiki-link\" data-key=\"a6b993090ded372fe156dd117dee2e3d\">Bode Cellmark Forensics, Inc.<\/a>\n<\/td>\n<td>BodeLIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Brooks_Automation,_Inc.\" title=\"Brooks Automation, Inc.\" class=\"wiki-link\" data-key=\"7b55775625992e844044c5db215b4a91\">Brooks Automation, Inc.<\/a>\n<\/td>\n<td>FreezerPro, Limfinity\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Brooks_Automation,_Inc.#Pricing\" title=\"Brooks Automation, Inc.\" class=\"wiki-link\" data-key=\"742b86a9727d6a2bb745dd84a13c7025\">Pricingand<\/a> <a href=\"https:\/\/www.limswiki.org\/index.php\/Brooks_Automation,_Inc.#Demonstration_videos_and_other_media\" title=\"Brooks Automation, Inc.\" class=\"wiki-link\" data-key=\"7e51a247a999d1d5764abfeb2e2cbef2\">demonstration videos<\/a>\n<\/td>\n<td>Sample management solutions + LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Broughton_Software_Ltd.\" title=\"Broughton Software Ltd.\" class=\"wiki-link\" data-key=\"36876bf9799791e657042de2ac8d8789\">Broughton Software Ltd.<\/a>\n<\/td>\n<td>LabHQ\n<\/td>\n<td>Yes\n<\/td>\n<td>United Kingdom\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Broughton_Software_Ltd.#Pricing\" title=\"Broughton Software Ltd.\" class=\"wiki-link\" data-key=\"2cc4c87213ca5a1bd86ef95804fa06e0\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Broughton_Software_Ltd.#Demonstration_videos_and_other_media\" title=\"Broughton Software Ltd.\" class=\"wiki-link\" data-key=\"740127de2c1b35f24ad94960eeb7d8d5\">demonstration videos<\/a>\n<\/td>\n<td>Was formerly <a href=\"https:\/\/www.limswiki.org\/index.php\/SkySource_Ltd.\" title=\"SkySource Ltd.\" class=\"wiki-link\" data-key=\"9be554340543f2cbe618e55e908227d0\">SkySource Ltd.<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bruker_Corporation\" title=\"Bruker Corporation\" class=\"wiki-link\" data-key=\"e2bd7cbc36f8b89babe5bdf05359ad96\">Bruker Corporation<\/a>\n<\/td>\n<td>SampleTrack\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BTLIMS_Technologies\" title=\"BTLIMS Technologies\" class=\"wiki-link\" data-key=\"b0bab8c14f3ec455d7022afc1a637b82\">BTLIMS Technologies<\/a>\n<\/td>\n<td>BTLIMS, Lab Data Master\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bureau_Conseils_et_Services_SCRL\" title=\"Bureau Conseils et Services SCRL\" class=\"wiki-link\" data-key=\"d8675ebb80409f824415b7542ef48db9\">Bureau Conseils et Services SCRL<\/a>\n<\/td>\n<td>AQ Manager LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>Belgium\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bureau_Conseils_et_Services_SCRL#Pricing\" title=\"Bureau Conseils et Services SCRL\" class=\"wiki-link\" data-key=\"461aeaa90e815110bb33392404a6c8af\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Bureau_Conseils_et_Services_SCRL#Demonstration_videos_and_other_media\" title=\"Bureau Conseils et Services SCRL\" class=\"wiki-link\" data-key=\"aec2bf498668e6059bf740fe60879dfa\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bytewize_AB\" title=\"Bytewize AB\" class=\"wiki-link\" data-key=\"2b7e72632dace83ccc9312311dc06e57\">Bytewize AB<\/a>\n<\/td>\n<td>O3 LIMS, O3 LIMSXpress\n<\/td>\n<td>Yes\n<\/td>\n<td>Sweden\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bytewize_AB#Pricing\" title=\"Bytewize AB\" class=\"wiki-link\" data-key=\"261ed0ef1bab6fb709e31cacb19da8c8\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Bytewize_AB#Demonstration_videos_and_other_media\" title=\"Bytewize AB\" class=\"wiki-link\" data-key=\"33f783edb7e9cf6e06cf72e1cb20d500\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Caliber_Technologies_Pvt._Ltd.\" title=\"Caliber Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"16375ecc8397490e68f3b07616d0a0e9\">Caliber Technologies Pvt. Ltd.<\/a>\n<\/td>\n<td>CaliberLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Cannabliss_New_England,_LLC\" title=\"Cannabliss New England, LLC\" class=\"wiki-link\" data-key=\"d76a68a443ea72d14ee3502325455e6a\">Cannabliss New England, LLC<\/a>\n<\/td>\n<td>CannabLIS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Cannabis LIMS\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Capstone_Technology_Corporation\" title=\"Capstone Technology Corporation\" class=\"wiki-link\" data-key=\"a2fc3c8ff6fb9723cdfbff9f80c5646b\">Capstone Technology Corporation<\/a>\n<\/td>\n<td>dataPARC\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Cerebrum_Corporation\" title=\"Cerebrum Corporation\" class=\"wiki-link\" data-key=\"8b7c2c5d26707c984b51128c9eb5ab32\">Cerebrum Corporation<\/a>\n<\/td>\n<td>LABdivus\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Cargotrader,_Inc.\" title=\"Cargotrader, Inc.\" class=\"wiki-link\" data-key=\"8105c0465657c72e8d0be2a7184ac445\">Cargotrader, Inc.<\/a>\n<\/td>\n<td>Cargotester.com\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Carobar_Business_Solutions,_LLC\" title=\"Carobar Business Solutions, LLC\" class=\"wiki-link\" data-key=\"5d2aea56fc01ac3afe2f85f7b456ab61\">Carobar Business Solutions, LLC<\/a>\n<\/td>\n<td>reLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CC_Software,_LLC\" title=\"CC Software, LLC\" class=\"wiki-link\" data-key=\"e114a2d33c72e6fdc92c2da4b91b0901\">CC Software, LLC<\/a>\n<\/td>\n<td>Confident Cannabis LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CC_Software,_LLC#Demonstration_videos_and_other_media\" title=\"CC Software, LLC\" class=\"wiki-link\" data-key=\"319ee775a5fd6846979545b10530b237\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CellPort_Software,_LLC\" title=\"CellPort Software, LLC\" class=\"wiki-link\" data-key=\"32f7a6372f27c5a602d27d26359716f0\">CellPort Software, LLC<\/a>\n<\/td>\n<td>CellPort Cell Culture Suite\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CellPort_Software,_LLC#Demonstration_videos_and_other_media\" title=\"CellPort Software, LLC\" class=\"wiki-link\" data-key=\"61971b19cadfe5e2aecaa62df65b1661\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Systems_Ltd.\" title=\"Clinical Systems Ltd.\" class=\"wiki-link\" data-key=\"66286837326b10a5289a27ead39333e9\">Clinical Systems Ltd.<\/a>\n<\/td>\n<td>ClinAxys II\n<\/td>\n<td>No\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CliniSys_Group_Limited\" title=\"CliniSys Group Limited\" class=\"wiki-link\" data-key=\"60736d95aeb73552a1c141c7cda72d2e\">CliniSys Group Limited<\/a>\n<\/td>\n<td>Clinisys WinPath\n<\/td>\n<td>No\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>\n<\/td>\n<td>Part of the Clinisys brand of companies.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Clinisys_NV\" title=\"Clinisys NV\" class=\"wiki-link\" data-key=\"e9734e9bb4e6f03fed18b6e926f8d878\">Clinisys NV<\/a>\n<\/td>\n<td>Clinisys GLIMS, GLIMS Genetics, and DaVinci\n<\/td>\n<td>No\n<\/td>\n<td>Belgium\n<\/td>\n<td>\n<\/td>\n<td>Was MIPS NV until September 2022.<sup id=\"rdp-ebb-cite_ref-EjusticeClinisys_8-0\" class=\"reference\"><a href=\"#cite_note-EjusticeClinisys-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MIPSBenaming22_9-0\" class=\"reference\"><a href=\"#cite_note-MIPSBenaming22-9\">[9]<\/a><\/sup><br \/>Part of the Clinisys brand of companies.\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CliniSys,_Inc.\" title=\"CliniSys, Inc.\" class=\"wiki-link\" data-key=\"20889b2bc3d70218588a6c3be442c648\">CliniSys, Inc.<\/a>\n<\/td>\n<td>Clinisys ApolloLIMS and SQ Lab\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Renamed from Sunquest Information Systems, Inc. on May 31, 2022.<sup id=\"rdp-ebb-cite_ref-SunquestArtAmend22_10-0\" class=\"reference\"><a href=\"#cite_note-SunquestArtAmend22-10\">[10]<\/a><\/sup><br \/>Part of the Clinisys brand of companies.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CloudLIMS.com,_LLC\" title=\"CloudLIMS.com, LLC\" class=\"wiki-link\" data-key=\"1fd0120f26ee0671738287a672cb5d7f\">CloudLIMS.com, LLC<\/a>\n<\/td>\n<td>CloudLIMS, FreeLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CloudLIMS.com,_LLC#Pricing\" title=\"CloudLIMS.com, LLC\" class=\"wiki-link\" data-key=\"819bb9fd986cb52a1b0b206e277dfa5c\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/CloudLIMS.com,_LLC#Demonstration_videos_and_other_media\" title=\"CloudLIMS.com, LLC\" class=\"wiki-link\" data-key=\"e63c7704136b7e271d9ff2d11859d8f8\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Clyde_Computing_Ltd.\" title=\"Clyde Computing Ltd.\" class=\"wiki-link\" data-key=\"43a5bb0a0e14aa5a36b4bee002d50b59\">Clyde Computing Ltd.<\/a>\n<\/td>\n<td>Q-SYS LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Codon_Software_Private_Limited\" title=\"Codon Software Private Limited\" class=\"wiki-link\" data-key=\"fdb3b4981587a1d5631a76abad31f357\">Codon Software Private Limited<\/a>\n<\/td>\n<td>Codon LIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Columbia_Energy_%26_Environmental_Services,_Inc.\" title=\"Columbia Energy & Environmental Services, Inc.\" class=\"wiki-link\" data-key=\"cbd90f05224592ce6341ed25b5708c78\">Columbia Energy & Environmental Services, Inc.<\/a>\n<\/td>\n<td>OmniLIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CompuDrug_International,_Inc.\" title=\"CompuDrug International, Inc.\" class=\"wiki-link\" data-key=\"ba53da7fc4663bd296fd1bc446dbeaff\">CompuDrug International, Inc.<\/a>\n<\/td>\n<td>Laboratory Manager Plus\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Computing_Solutions,_Inc.\" title=\"Computing Solutions, Inc.\" class=\"wiki-link\" data-key=\"329d21666356f7a55739196f22cb8127\">Computing Solutions, Inc.<\/a>\n<\/td>\n<td>LabSoft LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Comsense_Datasystems_of_Australia\" title=\"Comsense Datasystems of Australia\" class=\"wiki-link\" data-key=\"c16065493b89163ad918da6be8afa23e\">Comsense Datasystems of Australia<\/a>\n<\/td>\n<td>ComLIMS\n<\/td>\n<td>No\n<\/td>\n<td>Australia\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Condition_Monitoring_International,_LLC\" title=\"Condition Monitoring International, LLC\" class=\"wiki-link\" data-key=\"c979415c29fdcb124250f4bf209ad141\">Condition Monitoring International, LLC<\/a>\n<\/td>\n<td>LabTrak\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Contec_Group_International_Ltd.\" title=\"Contec Group International Ltd.\" class=\"wiki-link\" data-key=\"eef5e9d4d462a9dcc2b9b2552824e096\">Contec Group International Ltd.<\/a>\n<\/td>\n<td>MADCAP\n<\/td>\n<td>Yes\n<\/td>\n<td>New Zealand\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Cosine_Consultants_Ltd.\" title=\"Cosine Consultants Ltd.\" class=\"wiki-link\" data-key=\"419e894798ea982e9446353344c9b558\">Cosine Consultants Ltd.<\/a>\n<\/td>\n<td>Fission LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Cyprus\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CSMS_Sp._z_o.o.\" title=\"CSMS Sp. z o.o.\" class=\"wiki-link\" data-key=\"01eb92867716dd4f00a88b7b2de15cbe\">CSMS Sp. z o.o.<\/a>\n<\/td>\n<td>CS-17 LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Poland\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Dassault_Syst%C3%A8mes_SA\" title=\"Dassault Syst\u00e8mes SA\" class=\"wiki-link\" data-key=\"1be69bd73e35bc3db0c3229284bf9416\">Dassault Syst\u00e8mes SA<\/a>\n<\/td>\n<td>BIOVIA Lab Management\n<\/td>\n<td>No\n<\/td>\n<td>France\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Dassault_Syst%C3%A8mes_SA#Demonstration_videos_and_other_media\" title=\"Dassault Syst\u00e8mes SA\" class=\"wiki-link\" data-key=\"b656871654bacc091f653278ea1e0bec\">Demonstration videos<\/a>\n<\/td>\n<td>Dassault acquired <a href=\"https:\/\/www.limswiki.org\/index.php\/Accelrys,_Inc.\" title=\"Accelrys, Inc.\" class=\"wiki-link\" data-key=\"80b4cca2a39ccb7ba8e07211d62267a7\">Accelrys, Inc.<\/a> on April 29, 2014.<sup id=\"rdp-ebb-cite_ref-DassAcqFinal_11-0\" class=\"reference\"><a href=\"#cite_note-DassAcqFinal-11\">[11]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Data_Systems_Integration_Group,_Inc.\" title=\"Data Systems Integration Group, Inc.\" class=\"wiki-link\" data-key=\"2c6090e8f0c754528a641dced3d56e9a\">Data Systems Integration Group, Inc.<\/a>\n<\/td>\n<td>RevolutionDx\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Data_Unlimited_International,_Inc.\" title=\"Data Unlimited International, Inc.\" class=\"wiki-link\" data-key=\"0e2f05ac1a8b4645a4f8218b8d444402\">Data Unlimited International, Inc.<\/a>\n<\/td>\n<td>Starfruit GeneTell, IdentiTrack, and Toxicology\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Datamine_Software_Ltd.\" title=\"Datamine Software Ltd.\" class=\"wiki-link\" data-key=\"2ec3c0c72883c746ce035593e8414a76\">Datamine Software Ltd.<\/a>\n<\/td>\n<td>CCLAS EL and CCLAS 6\n<\/td>\n<td>Yes\n<\/td>\n<td>United Kingdom\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Dataworks_Development,_Inc.#Demonstration_videos_and_other_media\" title=\"Dataworks Development, Inc.\" class=\"wiki-link\" data-key=\"363bac99a6f837ccf06e19e7676fab21\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Dataworks_Development,_Inc.\" title=\"Dataworks Development, Inc.\" class=\"wiki-link\" data-key=\"194d2c54aee56dd189ba02dd1c0dd252\">Dataworks Development, Inc.<\/a>\n<\/td>\n<td>Freezerworks\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Datamine_Software_Ltd.#Demonstration_videos_and_other_media\" title=\"Datamine Software Ltd.\" class=\"wiki-link\" data-key=\"4b1a582d6432919ccdb1387a4bc9fbc8\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Dedalus_Healthcare_Ltd.\" title=\"Dedalus Healthcare Ltd.\" class=\"wiki-link\" data-key=\"2c093b5f62159630effa427ebac136d2\">Dedalus Healthcare Ltd.<\/a>\n<\/td>\n<td>Dedalus LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>\n<\/td>\n<td>Pathology LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Deutsche_Telekom_Healthcare_Solutions_Netherlands_B.V.\" title=\"Deutsche Telekom Healthcare Solutions Netherlands B.V.\" class=\"wiki-link\" data-key=\"59d4d82d5ae163d75cd537be5e30e494\">Deutsche Telekom Healthcare Solutions Netherlands B.V.<\/a>\n<\/td>\n<td>LMS, SymPathy Lifecare\n<\/td>\n<td>No\n<\/td>\n<td>Netherlands\n<\/td>\n<td>\n<\/td>\n<td>Acquired Finalist Software Noord Nederland C.V.<br \/>and LMS in January 2019.<sup id=\"rdp-ebb-cite_ref-ToetTelekom19_12-0\" class=\"reference\"><a href=\"#cite_note-ToetTelekom19-12\">[12]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FinalistAcq_13-0\" class=\"reference\"><a href=\"#cite_note-FinalistAcq-13\">[13]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/DHC_Dr._Herterich_%26_Consultants_GmbH\" title=\"DHC Dr. Herterich & Consultants GmbH\" class=\"wiki-link\" data-key=\"24c3be2d9c67d4b7fb299f6674d59822\">DHC Dr. Herterich & Consultants GmbH<\/a>\n<\/td>\n<td>SAP QM\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Dialog_EDV_Systementwicklung_GmbH\" title=\"Dialog EDV Systementwicklung GmbH\" class=\"wiki-link\" data-key=\"6b356876b61fc0ab262b96797fb30d14\">dialog EDV Systementwicklung GmbH<\/a>\n<\/td>\n<td>diaLIMS\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/DiData,_Inc.\" title=\"DiData, Inc.\" class=\"wiki-link\" data-key=\"8c44b4ec1b7fa541a2bf18f1070292a8\">DiData, Inc.<\/a>\n<\/td>\n<td>Di-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Switzerland\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/DIPOLE_SARL\" title=\"DIPOLE SARL\" class=\"wiki-link\" data-key=\"22827eed6f9d68b4f64196d437a4d7c4\">DIPOLE SARL<\/a>\n<\/td>\n<td>DipLABO\n<\/td>\n<td>No\n<\/td>\n<td>France\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Diversity_Arrays_Technology_Pty._Ltd.\" title=\"Diversity Arrays Technology Pty. Ltd.\" class=\"wiki-link\" data-key=\"722d494b4a501396f78b7db0cf6e4da7\">Diversity Arrays Technology Pty. Ltd.<\/a>\n<\/td>\n<td>DArT LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Australia\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Diversity_Arrays_Technology_Pty._Ltd.#Demonstration_videos_and_other_media\" title=\"Diversity Arrays Technology Pty. Ltd.\" class=\"wiki-link\" data-key=\"8d020a18e82481e97544e56806fc2db6\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Dorner_GmbH_%26_Co._KG\" title=\"Dorner GmbH & Co. KG\" class=\"wiki-link\" data-key=\"9118778b5a78d1f32e6ac1e4c3cc3719\">Dorner GmbH & Co. KG<\/a>\n<\/td>\n<td>B\/Lab, i\/med Genetics, i\/med Hygiene,<br \/>M\/Lab, X\/Lab\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Drishti-Soft_Solutions_Pvt._Ltd.\" title=\"Drishti-Soft Solutions Pvt. Ltd.\" class=\"wiki-link\" data-key=\"510f84cf4f4427748a389cc10f66c2a9\">Drishti-Soft Solutions Pvt. Ltd.<\/a>\n<\/td>\n<td>cLIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Dynamic_Databases,_LLC\" title=\"Dynamic Databases, LLC\" class=\"wiki-link\" data-key=\"d14deba3fae14529fb9217061071efd8\">Dynamic Databases, LLC<\/a>\n<\/td>\n<td>limsExpress\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Dynamic_Databases,_LLC#Demonstration_videos_and_other_media\" title=\"Dynamic Databases, LLC\" class=\"wiki-link\" data-key=\"5cb65bda68a05141df00f71778a68247\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/E-BiOnary_Technologies_Pvt._Ltd.\" title=\"E-BiOnary Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"5738a6ec04f3583aae30e4a53a2177ee\">E-BiOnary Technologies Pvt. Ltd.<\/a>\n<\/td>\n<td>e-BiOnary A, C, M, and D\n<\/td>\n<td>Yes\n<\/td>\n<td>India\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/E-BiOnary_Technologies_Pvt._Ltd.#Demonstration_videos_and_other_media\" title=\"E-BiOnary Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"7b04375a35d7dfb972619bf86cd1c54c\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/EffiChem_s.r.o.\" title=\"EffiChem s.r.o.\" class=\"wiki-link\" data-key=\"5b717fdaab6035ca1e9debad0b34bfd7\">EffiChem s.r.o.<\/a>\n<\/td>\n<td>EffiChem\n<\/td>\n<td>Yes\n<\/td>\n<td>Czech Republic\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/EffiChem_s.r.o.#Demonstration_videos_and_other_media\" title=\"EffiChem s.r.o.\" class=\"wiki-link\" data-key=\"b684bc476de9786ff2da2c3d7dc1a4a1\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Elysia-raytest_GmbH\" title=\"Elysia-raytest GmbH\" class=\"wiki-link\" data-key=\"b6e58152b2375851ffb5bf090a767f5d\">Elysia-raytest GmbH<\/a>\n<\/td>\n<td>Argus RPS, SARA\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>Specializes in radiopharmaceutical LIMS.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ElmTree_Systems,_LLC\" title=\"ElmTree Systems, LLC\" class=\"wiki-link\" data-key=\"4273e298c652c7d4abb8d58612c08382\">ElmTree Systems, LLC<\/a>\n<\/td>\n<td>ElmTree System\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Elmwood_Solutions,_Inc.\" title=\"Elmwood Solutions, Inc.\" class=\"wiki-link\" data-key=\"61d66cb9e94b9931e9ac073b6bb0772c\">Elmwood Solutions, Inc.<\/a>\n<\/td>\n<td>Pure Harvest\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>LIMS-like seed lab software\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Enable_IT_Solutions_Pvt._Ltd.\" title=\"Enable IT Solutions Pvt. Ltd.\" class=\"wiki-link\" data-key=\"9fa4641a5889cb112cefcdb89fe00319\">Enable IT Solutions Pvt. Ltd.<\/a>\n<\/td>\n<td>Ens\u014d-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Enable_IT_Solutions_Pvt._Ltd.#Demonstration_videos_and_other_media\" title=\"Enable IT Solutions Pvt. Ltd.\" class=\"wiki-link\" data-key=\"46f56d474f569685c669edfc9dce6707\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Entimo_AG\" title=\"Entimo AG\" class=\"wiki-link\" data-key=\"ba2e45dc5f9a3c287232d1f6b12aeb8a\">entimo AG<\/a>\n<\/td>\n<td>PhaLIMS\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/EthoSoft,_Inc.\" title=\"EthoSoft, Inc.\" class=\"wiki-link\" data-key=\"156215cce405b4769b309ec10daeb61e\">EthoSoft, Inc.<\/a>\n<\/td>\n<td>X-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/EthoSoft,_Inc.#Pricing\" title=\"EthoSoft, Inc.\" class=\"wiki-link\" data-key=\"98e9410f8dfeb0f77a53240d3764c02b\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Eusoft_Srl\" title=\"Eusoft Srl\" class=\"wiki-link\" data-key=\"b325934cae067817cae507c40d9e4e5c\">Eusoft Srl<\/a>\n<\/td>\n<td>EuSoft.Lab\n<\/td>\n<td>Yes\n<\/td>\n<td>Italy\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Eusoft_Srl#Demonstration_videos_and_other_media\" title=\"Eusoft Srl\" class=\"wiki-link\" data-key=\"75b9d2db2057b45e3f80b4ded7c2a6f3\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Fink_%26_Partner_GmbH\" title=\"Fink & Partner GmbH\" class=\"wiki-link\" data-key=\"43f0cad9a6e1e7fa5923e3ce0babe9fa\">Fink & Partner GmbH<\/a>\n<\/td>\n<td>[FP]-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Fink_%26_Partner_GmbH#Demonstration_videos_and_other_media\" title=\"Fink & Partner GmbH\" class=\"wiki-link\" data-key=\"4f2fd4c3efc73542316f104696dfe309\">Demonstration videos<\/a>\n<\/td>\n<td>Former product was [Dia]\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Forney,_LP\" title=\"Forney, LP\" class=\"wiki-link\" data-key=\"0215cbcbd60b4ca3f243423398a9830b\">Forney, LP<\/a>\n<\/td>\n<td>ForneyVault\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Forney,_LP#Pricing\" title=\"Forney, LP\" class=\"wiki-link\" data-key=\"afe15c69cd7d3389bc921818d58040fd\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Forney,_LP#Demonstration_videos_and_other_media\" title=\"Forney, LP\" class=\"wiki-link\" data-key=\"a344c75efb387ddb45ba87249e98f1e8\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Frontier_Science_%26_Technology_Research_Foundation,_Inc.\" title=\"Frontier Science & Technology Research Foundation, Inc.\" class=\"wiki-link\" data-key=\"534d25fba94149c3ccc59d94e1ff7d90\">Frontier Science & Technology Research Foundation, Inc.<\/a>\n<\/td>\n<td>LDMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Frontier_Science_%26_Technology_Research_Foundation,_Inc.#Demonstration_videos_and_other_media\" title=\"Frontier Science & Technology Research Foundation, Inc.\" class=\"wiki-link\" data-key=\"190765674c4f9c6c11eb216c6ff993e2\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Future_Technologies,_Inc.\" title=\"Future Technologies, Inc.\" class=\"wiki-link\" data-key=\"4097e35d9bbda909a18d28054f78e0ca\">Future Technologies, Inc.<\/a>\n<\/td>\n<td>DNA LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Genesis_MicroSystems,_Inc.\" title=\"Genesis MicroSystems, Inc.\" class=\"wiki-link\" data-key=\"f2d032fd7d37ef6ef035ea7457542b91\">Genesis MicroSystems, Inc.<\/a>\n<\/td>\n<td>LAB-2000\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Genetic_Technologies,_Inc.\" title=\"Genetic Technologies, Inc.\" class=\"wiki-link\" data-key=\"e0b4e58d41d67172a0a77e0438ec5803\">Genetic Technologies, Inc.<\/a>\n<\/td>\n<td>eDNA LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Genetic_Technologies,_Inc.#Pricing\" title=\"Genetic Technologies, Inc.\" class=\"wiki-link\" data-key=\"cfa31bd77588b3e06bb781cb27adf1aa\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Genetrics,_Inc.\" title=\"Genetrics, Inc.\" class=\"wiki-link\" data-key=\"47c7a0326237fcc0647e8b3d5750ba73\">Genetrics, Inc.<\/a>\n<\/td>\n<td>GEN-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United Arab Emirates\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Genial_Genetic_Solutions,_Ltd.\" title=\"Genial Genetic Solutions, Ltd.\" class=\"wiki-link\" data-key=\"f56fb3085e4c77533b01bdec155db020\">Genial Genetic Solutions, Ltd.<\/a>\n<\/td>\n<td>iGene, Shire\n<\/td>\n<td>No\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/GenoFAB,_Inc.\" title=\"GenoFAB, Inc.\" class=\"wiki-link\" data-key=\"44da146a750f87c1ee2457ccd6bdf79e\">GenoFAB, Inc.<\/a>\n<\/td>\n<td>GenoFAB\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/GenoFAB,_Inc.#Pricing\" title=\"GenoFAB, Inc.\" class=\"wiki-link\" data-key=\"122002b19dc0022445d0c6da7da9ae83\">Pricing<\/a>\n<\/td>\n<td>Combination LIMS + ELN\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Genosity,_Inc.\" title=\"Genosity, Inc.\" class=\"wiki-link\" data-key=\"a46764fa8b774c307bad72593fa5793b\">Genosity, Inc.<\/a>\n<\/td>\n<td>Integrated Genomic Toolkit\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Genomics\" title=\"Genomics\" class=\"wiki-link\" data-key=\"96a82dabf51cf9510dd00c5a03396c44\">Genomics<\/a> platform with a LIMS\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/GoInformatics,_Inc.\" title=\"GoInformatics, Inc.\" class=\"wiki-link\" data-key=\"c0ed00d2cec0a5f3dd0b6ef5fc2290de\">GoInformatics, Inc.<\/a>\n<\/td>\n<td>GoLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/GoInformatics,_Inc.#Demonstration_videos_and_other_media\" title=\"GoInformatics, Inc.\" class=\"wiki-link\" data-key=\"9937263c7e2fe6b6e36badd821408518\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/GoMeyra_Corporation\" title=\"GoMeyra Corporation\" class=\"wiki-link\" data-key=\"4ebec47c2fc9ccfd631c5895c19c0943\">GoMeyra Corporation<\/a>\n<\/td>\n<td>GoMeyra LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/GoMeyra_Corporation#Demonstration_videos_and_other_media\" title=\"GoMeyra Corporation\" class=\"wiki-link\" data-key=\"5e86becf125f7ce7728ca250e113c527\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/GQM_mbH\" title=\"GQM mbH\" class=\"wiki-link\" data-key=\"eb67925aadd0ecaf5d9b209d07b24d8c\">GQM mbH<\/a>\n<\/td>\n<td>Qualifax LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/GTS_Systems_Private_Limited\" title=\"GTS Systems Private Limited\" class=\"wiki-link\" data-key=\"9d0a464234e2aa9470297068a9fdc733\">GTS Systems Private Limited<\/a>\n<\/td>\n<td>GLab360, LabExpress\n<\/td>\n<td>Yes\n<\/td>\n<td>Egypt\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/H%26A_Scientific,_Inc.\" title=\"H&A Scientific, Inc.\" class=\"wiki-link\" data-key=\"9c8b6462f7e14e032cde0f6cd3f9eb1d\">H&A Scientific, Inc.<\/a>\n<\/td>\n<td>SLIM\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/H%26A_Scientific,_Inc.#Demonstration_videos_and_other_media\" title=\"H&A Scientific, Inc.\" class=\"wiki-link\" data-key=\"959e9a46d7d7d5517ba8bb16e4f51872\">Screenshots<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Hach_Company\" title=\"Hach Company\" class=\"wiki-link\" data-key=\"3cf7b58de678c14c01527a961e43fad6\">Hach Company<\/a>\n<\/td>\n<td>Hach WIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States, Germany\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Hach_Company#Demonstration_videos_and_other_media\" title=\"Hach Company\" class=\"wiki-link\" data-key=\"9a5e58ef21ae8933bd14e09a40dd52fc\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Harris_Systems_USA,_Inc.\" title=\"Harris Systems USA, Inc.\" class=\"wiki-link\" data-key=\"cafbfb882706bc97220e8b19f55e05f4\">Harris Systems USA, Inc.<\/a>\n<\/td>\n<td>Forensic Advantage\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Placed under Harris' Caliber Public Safety division.<sup id=\"rdp-ebb-cite_ref-CaliberFA_14-0\" class=\"reference\"><a href=\"#cite_note-CaliberFA-14\">[14]<\/a><\/sup>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/HM-Software\" title=\"HM-Software\" class=\"wiki-link\" data-key=\"6c7956684446f3644a9190ad767d8bd4\">HM-Software<\/a>\n<\/td>\n<td>HM-LAB\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/I2D_Solution,_Inc.\" title=\"I2D Solution, Inc.\" class=\"wiki-link\" data-key=\"2d547d8704e8797f71e2e8cef4b055ea\">i2D Solution, Inc.<\/a>\n<\/td>\n<td>i2DS LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ICD_System_GmbH\" title=\"ICD System GmbH\" class=\"wiki-link\" data-key=\"9c92f6b256261d7360ea5482158905b0\">iCD System GmbH<\/a>\n<\/td>\n<td>LABS\/Q, LABS\/QM\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Illumina,_Inc.\" title=\"Illumina, Inc.\" class=\"wiki-link\" data-key=\"ca3eee9e7b220194a53536295b15ba2b\">Illumina, Inc.<\/a>\n<\/td>\n<td>BaseSpace Clarity LIMS, Illumina LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Illumina,_Inc.#Demonstration_videos_and_other_media\" title=\"Illumina, Inc.\" class=\"wiki-link\" data-key=\"bdd87caaf253a3713969b121ef59e8c2\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/In-QM-Team_Software_GmbH\" title=\"In-QM-Team Software GmbH\" class=\"wiki-link\" data-key=\"d60c66c253ab143f9f16df0a71474835\">In-QM-Team Software GmbH<\/a>\n<\/td>\n<td>WinLaisy\n<\/td>\n<td>No\n<\/td>\n<td>Europe\n<\/td>\n<td>\n<\/td>\n<td>Development taken over from <a href=\"https:\/\/www.limswiki.org\/index.php\/Inray_Industriesoftware_GmbH\" title=\"Inray Industriesoftware GmbH\" class=\"wiki-link\" data-key=\"b49b2cec2fdca7aba0b86761e8cb83d8\">inray Industriesoftware GmbH<\/a><br \/>in March 2019.<sup id=\"rdp-ebb-cite_ref-MWDasQM19_15-0\" class=\"reference\"><a href=\"#cite_note-MWDasQM19-15\">[15]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Indusoft_OOO\" title=\"Indusoft OOO\" class=\"wiki-link\" data-key=\"e1d8aa6fb09855894f9797b012a9c79e\">Indusoft OOO<\/a>\n<\/td>\n<td>I-LDS LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Russia\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Indusoft_OOO#Demonstration_videos_and_other_media\" title=\"Indusoft OOO\" class=\"wiki-link\" data-key=\"f60636c29760d9961063f03e317947a7\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Infomed_Kouvatsos_Theodoros_Ltd.\" title=\"Infomed Kouvatsos Theodoros Ltd.\" class=\"wiki-link\" data-key=\"dc8bec198fc63e883ee5ce40920e94b7\">Infomed Kouvatsos Theodoros Ltd.<\/a>\n<\/td>\n<td>Lab@link\n<\/td>\n<td>No\n<\/td>\n<td>Greece\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Information_Management_Services,_Inc.\" title=\"Information Management Services, Inc.\" class=\"wiki-link\" data-key=\"5bf8c69bf0b0e01853d1f104403f9ca2\">Information Management Services, Inc.<\/a>\n<\/td>\n<td>BSI, SEER*DMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Information_Management_Services,_Inc.#Pricing\" title=\"Information Management Services, Inc.\" class=\"wiki-link\" data-key=\"fabe70c0e6109bb80d103d100c6c977a\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Information_Management_Services,_Inc.#Demonstration_videos_and_other_media\" title=\"Information Management Services, Inc.\" class=\"wiki-link\" data-key=\"fe6b7e55e1050a7b3ccf16ddbce31983\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/InfoTrak_Pty._Ltd.\" title=\"InfoTrak Pty. Ltd.\" class=\"wiki-link\" data-key=\"42fcad452b38e28ac846d39d3f538658\">InfoTrak Pty. Ltd.<\/a>\n<\/td>\n<td>Oil Commander\n<\/td>\n<td>No\n<\/td>\n<td>Australia\n<\/td>\n<td>\n<\/td>\n<td>Previous product name was InfoTrak Oil.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Innovatics_Ky\" title=\"Innovatics Ky\" class=\"wiki-link\" data-key=\"63f27b0bb2ff672a0803d07c33b242d9\">Innovatics Ky<\/a>\n<\/td>\n<td>InnoLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>Finland\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Instem_LSS_Limited\" title=\"Instem LSS Limited\" class=\"wiki-link\" data-key=\"9489fbd224d657a73604e010017a73c3\">Instem LSS Limited<\/a>\n<\/td>\n<td>Provantis\n<\/td>\n<td>Yes\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Instrumentos_Cient%C3%ADficos_SA\" title=\"Instrumentos Cient\u00edficos SA\" class=\"wiki-link\" data-key=\"24ff4cde6d9cc0e4d2a2cb8c60c66670\">Instrumentos Cient\u00edficos SA<\/a>\n<\/td>\n<td>NevisLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>Spain\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Instrumentos_Cient%C3%ADficos_SA#Demonstration_videos_and_other_media\" title=\"Instrumentos Cient\u00edficos SA\" class=\"wiki-link\" data-key=\"98ec124c819abe7cbd31794fb0db88b7\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/IntaForensics_Ltd.\" title=\"IntaForensics Ltd.\" class=\"wiki-link\" data-key=\"bbc4b6effcd8c9c5f5b630bc7397dd97\">IntaForensics Ltd.<\/a>\n<\/td>\n<td>Lima Forensic Case Management\n<\/td>\n<td>No\n<\/td>\n<td>United Kingdom\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/IntaForensics_Ltd.#Pricing\" title=\"IntaForensics Ltd.\" class=\"wiki-link\" data-key=\"defa7ff592c8b6e80aa1f298e81b5b80\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/IntaForensics_Ltd.#Demonstration_videos_and_other_media\" title=\"IntaForensics Ltd.\" class=\"wiki-link\" data-key=\"f05041573e7bdd2b243bd1e1bb52362a\">demonstration videos<\/a>\n<\/td>\n<td>Personal edition is free, but no other pricing.\n<\/td><\/tr>\n\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Integrated_Software_Solutions_Ltd.\" title=\"Integrated Software Solutions Ltd.\" class=\"wiki-link\" data-key=\"195adbc3067b09c5a990676b6318d365\">Integrated Software Solutions Ltd.<\/a>\n<\/td>\n<td>OMNI-Lab\n<\/td>\n<td>No\n<\/td>\n<td>Australia\n<\/td>\n<td>\n<\/td>\n<td>Absorbed Point of Care Solutions Pty. Ltd. and v-Lab in 2020.<sup id=\"rdp-ebb-cite_ref-PCSArch_16-0\" class=\"reference\"><a href=\"#cite_note-PCSArch-16\">[16]<\/a><\/sup>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/INTEGRIS_LIMS_GmbH\" title=\"INTEGRIS LIMS GmbH\" class=\"wiki-link\" data-key=\"7d40e4f2def2349fe04a1e7797df73ff\">INTEGRIS LIMS GmbH<\/a>\n<\/td>\n<td>iLIMS\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/INTEGRIS_LIMS_GmbH#Pricing\" title=\"INTEGRIS LIMS GmbH\" class=\"wiki-link\" data-key=\"756401e5c94e6e07fc03e21d1f60cbd7\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/INTEGRIS_LIMS_GmbH#Demonstration_videos_and_other_media\" title=\"INTEGRIS LIMS GmbH\" class=\"wiki-link\" data-key=\"c48e99d06e9753eaa7ffada47d92b8b6\">demonstration videos<\/a>\n<\/td>\n<td>Changed company name from <a href=\"https:\/\/www.limswiki.org\/index.php\/CSS_LIMS_GmbH\" title=\"CSS LIMS GmbH\" class=\"wiki-link\" data-key=\"096a061deca9266885da20930eec8272\">CSS LIMS GmbH<\/a> in March 2017.<sup id=\"rdp-ebb-cite_ref-IntegrisRenaming17_17-0\" class=\"reference\"><a href=\"#cite_note-IntegrisRenaming17-17\">[17]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Interactive_Software_Limited\" title=\"Interactive Software Limited\" class=\"wiki-link\" data-key=\"289fe497b507f43786b27099f78dd023\">Interactive Software Limited<\/a>\n<\/td>\n<td>Achiever Medical LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Interactive_Technology_Services,_LLC\" title=\"Interactive Technology Services, LLC\" class=\"wiki-link\" data-key=\"caa7d37e55619fc80cfa0928243b6ab8\">Interactive Technology Services, LLC<\/a>\n<\/td>\n<td>LIMS IAL\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Interpec_Corporation\" title=\"Interpec Corporation\" class=\"wiki-link\" data-key=\"af8c1fa82f588b3daab92accf2e35b1a\">Interpec Corporation<\/a>\n<\/td>\n<td>INQAS, INTRACES\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/InterSystems_Corporation\" title=\"InterSystems Corporation\" class=\"wiki-link\" data-key=\"148a499ad7e73769de328a0336ca2bab\">InterSystems Corporation<\/a>\n<\/td>\n<td>TrakCare Lab\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/InterSystems_Corporation#Demonstration_videos_and_other_media\" title=\"InterSystems Corporation\" class=\"wiki-link\" data-key=\"93a9c2058177343a9dbc58d8a5cb76de\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/InVita_Healthcare_Technologies,_Inc.\" title=\"InVita Healthcare Technologies, Inc.\" class=\"wiki-link\" data-key=\"49a1f92f623a6ad86362c4ddfeca7475\">InVita Healthcare Technologies, Inc.<\/a>\n<\/td>\n<td>STACS Casework, STACS Database\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Acquired from <a href=\"https:\/\/www.limswiki.org\/index.php\/STaCS_DNA_Inc.\" title=\"STaCS DNA Inc.\" class=\"wiki-link\" data-key=\"0946ef888e904455ee39b28ce981bbdf\">STaCS DNA Inc.<\/a> in May 2021.<sup id=\"rdp-ebb-cite_ref-NobileRiverside21_18-0\" class=\"reference\"><a href=\"#cite_note-NobileRiverside21-18\">[18]<\/a><\/sup>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/IVention_BV\" title=\"IVention BV\" class=\"wiki-link\" data-key=\"bdc72c7c692380534c8989ec8f285a7f\">iVention BV<\/a>\n<\/td>\n<td>iVentionLES\n<\/td>\n<td>Yes\n<\/td>\n<td>Netherlands\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/IVention_BV#Demonstration_videos_and_other_media\" title=\"IVention BV\" class=\"wiki-link\" data-key=\"697d87890268330fe21bbfbe5518db69\">Demonstration videos<\/a>\n<\/td>\n<td>Marketed as a laboratory execution system with LIMS,<br \/>ELN, and SDMS functionality\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/J_Street_Technology,_Inc.\" title=\"J Street Technology, Inc.\" class=\"wiki-link\" data-key=\"f2eafb5bd42e943aa99fad1f0978bf30\">J Street Technology, Inc.<\/a>\n<\/td>\n<td>J Street LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/J_Street_Technology,_Inc.#Pricing\" title=\"J Street Technology, Inc.\" class=\"wiki-link\" data-key=\"6489ba619b4d5be18d3d1a3567926220\">Pricing<\/a>\n<\/td>\n<td>Formerly MSC-LIMS by <a href=\"https:\/\/www.limswiki.org\/index.php\/Mountain_States_Consulting,_LLC\" title=\"Mountain States Consulting, LLC\" class=\"wiki-link\" data-key=\"07aa1abcf286c45d2d5f3b6713e6d43d\">Mountain States Consulting, LLC<\/a>.\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Jeganee_Technologies_Pvt._Ltd.\" title=\"Jeganee Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"98ca150cf6c01ddeb40ff2d2fdf521ab\">Jeganee Technologies Pvt. Ltd.<\/a>\n<\/td>\n<td>Laboratory-On\n<\/td>\n<td>Yes\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/JusticeTrax,_Inc.\" title=\"JusticeTrax, Inc.\" class=\"wiki-link\" data-key=\"ce36173af358f2fd823c8fe50983f55a\">JusticeTrax, Inc.<\/a>\n<\/td>\n<td>LIMS-plus\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/JusticeTrax,_Inc.#Pricing\" title=\"JusticeTrax, Inc.\" class=\"wiki-link\" data-key=\"1d6d09ef8170aaca55f6ac83e0d0d998\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/JwConsulting_GmbH\" title=\"JwConsulting GmbH\" class=\"wiki-link\" data-key=\"15345c6320dafa2ef727125b130de8c5\">jwConsulting GmbH<\/a>\n<\/td>\n<td>jwLIMS\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Khemia_Software,_Inc.\" title=\"Khemia Software, Inc.\" class=\"wiki-link\" data-key=\"5cb8c7dcab558ad071fd7f9666b88baa\">Khemia Software, Inc.<\/a>\n<\/td>\n<td>Omega 11 LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Khemia_Software,_Inc.#Demonstration_videos_and_other_media\" title=\"Khemia Software, Inc.\" class=\"wiki-link\" data-key=\"287ad2c48680d1a650bf9c0b3978e4b5\">Screenshots<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Kriti_Microsystems_Pvt._Ltd.\" title=\"Kriti Microsystems Pvt. Ltd.\" class=\"wiki-link\" data-key=\"3a180855ec982b1ccd6713cd66b38162\">Kriti Microsystems Pvt. Ltd.<\/a>\n<\/td>\n<td>Kriti LIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/KVANT_spol._s_r.o.\" title=\"KVANT spol. s r.o.\" class=\"wiki-link\" data-key=\"ee56914a8adf1c7a675425be5c5252e2\">KVANT spol. s r.o.<\/a>\n<\/td>\n<td>Evidence\n<\/td>\n<td>No\n<\/td>\n<td>Slovakia\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/L7_Informatics,_Inc.\" title=\"L7 Informatics, Inc.\" class=\"wiki-link\" data-key=\"ae1e0f933010a008daa9d74438f84838\">L7 Informatics, Inc.<\/a>\n<\/td>\n<td>L7 ESP\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Lab7_Systems,_Inc.#Demonstration_videos_and_other_media\" class=\"mw-redirect wiki-link\" title=\"Lab7 Systems, Inc.\" data-key=\"b4de259e9d884bc6745b2c441bb89fce\">Demonstration videos<\/a>\n<\/td>\n<td>Enterprise science platform\/workflow engine w\/ a LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabCloud,_Inc.\" title=\"LabCloud, Inc.\" class=\"wiki-link\" data-key=\"d85397fcc4e2250effbe8c59f55865ff\">LabCloud, Inc.<\/a>\n<\/td>\n<td>LabCloud\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labforward_GmbH\" title=\"Labforward GmbH\" class=\"wiki-link\" data-key=\"8a9842138692008e4f5896ee023849ab\">Labforward GmbH<\/a>\n<\/td>\n<td>Labregister\n<\/td>\n<td>Yes\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>Integrates with company's ELN Labfolder\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labii,_Inc.\" title=\"Labii, Inc.\" class=\"wiki-link\" data-key=\"26694f1b8383d3bce3421b9e4dc2cfc7\">Labii, Inc.<\/a>\n<\/td>\n<td>Labii ELN & LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labii,_Inc.#Pricing\" title=\"Labii, Inc.\" class=\"wiki-link\" data-key=\"9ff93db3690143b30541e5f2caa5fdfa\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Labii,_Inc.#Demonstration_videos_and_other_media\" title=\"Labii, Inc.\" class=\"wiki-link\" data-key=\"f293c56d196d80655380ea5c2a52eac9\">demonstration videos<\/a>\n<\/td>\n<td>Combination ELN + LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabKey_Corporation\" title=\"LabKey Corporation\" class=\"wiki-link\" data-key=\"7946a04728c692073f0c0202ba4bdce9\">LabKey Corporation<\/a>\n<\/td>\n<td>LabKey Biologics LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabKey_Corporation#Pricing\" title=\"LabKey Corporation\" class=\"wiki-link\" data-key=\"04ca129267ca46d7b4cf85206e395267\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/LabKey_Corporation#Demonstration_videos_and_other_media\" title=\"LabKey Corporation\" class=\"wiki-link\" data-key=\"85dcac5fb36bd3a699878ed1d141f6e2\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabLite,_LLC\" title=\"LabLite, LLC\" class=\"wiki-link\" data-key=\"9d263b476476ba224f4f002ea2c7e039\">LabLite, LLC<\/a>\n<\/td>\n<td>LabLite SQL LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabLite,_LLC#Pricing\" title=\"LabLite, LLC\" class=\"wiki-link\" data-key=\"dfbfb0d3425b6e7377bbe03af0f53dec\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabLogic_Systems_Limited\" title=\"LabLogic Systems Limited\" class=\"wiki-link\" data-key=\"2747fe5d0c1ad8b79607fde2eb629357\">LabLogic Systems Limited<\/a>\n<\/td>\n<td>Debra, PETra\n<\/td>\n<td>No\n<\/td>\n<td>United Kingdom\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabLogic_Systems_Limited#Demonstration_videos_and_other_media\" title=\"LabLogic Systems Limited\" class=\"wiki-link\" data-key=\"c69d099ff5f840ae2528c6a8c94538fd\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabLynx,_Inc.\" title=\"LabLynx, Inc.\" class=\"wiki-link\" data-key=\"da3f96536cf2c54de1960f26fe5712a1\">LabLynx, Inc.<\/a>\n<\/td>\n<td>ELab\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabLynx,_Inc.#Pricing\" title=\"LabLynx, Inc.\" class=\"wiki-link\" data-key=\"1987fef21562ef41b83935e10c0d89e7\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/LabLynx,_Inc.#Demonstration_videos_and_other_media\" title=\"LabLynx, Inc.\" class=\"wiki-link\" data-key=\"d41bd114f1d4bcd40230e98afc528135\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabMaster.pl_Sp._z_o.o.\" title=\"LabMaster.pl Sp. z o.o.\" class=\"wiki-link\" data-key=\"cfbbe5e6f5f1ef3fdcf3fedb05d8572d\">LabMaster.pl Sp. z o.o.<\/a>\n<\/td>\n<td>LabMaster LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>Poland\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labmin_(Pty)_Ltd.\" title=\"Labmin (Pty) Ltd.\" class=\"wiki-link\" data-key=\"c544b32e0a80e7c953b3a8190631ea55\">Labmin (Pty) Ltd.<\/a>\n<\/td>\n<td>Labmin, Labmin Lite\n<\/td>\n<td>Yes\n<\/td>\n<td>South Africa\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labmin_(Pty)_Ltd.#Demonstration_videos_and_other_media\" title=\"Labmin (Pty) Ltd.\" class=\"wiki-link\" data-key=\"ec8deea7eb6c32d0a5a7ad029724bde0\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabPro_2000_Ltd.\" title=\"LabPro 2000 Ltd.\" class=\"wiki-link\" data-key=\"2ee0d5be189b246e1361bdaaecc71374\">LabPro 2000 Ltd.<\/a>\n<\/td>\n<td>eQual\n<\/td>\n<td>Yes\n<\/td>\n<td>New Zealand\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labs_Division_SL\" title=\"Labs Division SL\" class=\"wiki-link\" data-key=\"53ffe0c0e6e66b7e9fc855b1b2d98326\">Labs Division SL<\/a>\n<\/td>\n<td>OraLims 2000i and 3.0\n<\/td>\n<td>Yes\n<\/td>\n<td>Spain\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labs_Division_SL#Demonstration_videos_and_other_media\" title=\"Labs Division SL\" class=\"wiki-link\" data-key=\"05d022c241932459b0fa6134bf76205f\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labsoft_Tecnologia_Ltda.\" title=\"Labsoft Tecnologia Ltda.\" class=\"wiki-link\" data-key=\"442903b6b6e45f0bd21152b0cb522734\">Labsoft Tecnologia Ltda.<\/a>\n<\/td>\n<td>myLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>Brazil\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labsoft_Tecnologia_Ltda.#Demonstration_videos_and_other_media\" title=\"Labsoft Tecnologia Ltda.\" class=\"wiki-link\" data-key=\"25520908834791bdc36360323e98f619\">Demonstration videos<\/a>\n<\/td>\n<td>Not to be confused with <a href=\"https:\/\/www.limswiki.org\/index.php\/Odysis_SA\" title=\"Odysis SA\" class=\"wiki-link\" data-key=\"c2d0e9c0d904948b53d63a2bb12defb5\">Odysis SA's<\/a> myLIMS product.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labstudio_(Pty)_Ltd.\" title=\"Labstudio (Pty) Ltd.\" class=\"wiki-link\" data-key=\"69517461ac0f50c79af5ab8c543a0f9f\">Labstudio (Pty) Ltd.<\/a>\n<\/td>\n<td>Labstud.io LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>South Africa\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labstudio_(Pty)_Ltd.#Pricing\" title=\"Labstudio (Pty) Ltd.\" class=\"wiki-link\" data-key=\"683e045a858bd5e93f9929eae5f4bbb4\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Labmin_(Pty)_Ltd.#Demonstration_videos_and_other_media\" title=\"Labmin (Pty) Ltd.\" class=\"wiki-link\" data-key=\"ec8deea7eb6c32d0a5a7ad029724bde0\">screenshots<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LABTrack,_LLC\" title=\"LABTrack, LLC\" class=\"wiki-link\" data-key=\"b66631d9efae062d973eb24c8e88a790\">LABTrack, LLC<\/a>\n<\/td>\n<td>LABTrack LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td> was previously a distributor of LABTrack.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabVantage_Solutions,_Inc.\" title=\"LabVantage Solutions, Inc.\" class=\"wiki-link\" data-key=\"1855d5158d4dd8f748e925e626daf5ee\">LabVantage Solutions, Inc.<\/a>\n<\/td>\n<td>LabVantage 8\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabVantage_Solutions,_Inc.#Pricing\" title=\"LabVantage Solutions, Inc.\" class=\"wiki-link\" data-key=\"df1f54a0ec886a57094321dfc575f55f\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/LabVantage_Solutions,_Inc.#Demonstration_videos_and_other_media\" title=\"LabVantage Solutions, Inc.\" class=\"wiki-link\" data-key=\"3002695581b7b7561b26a690fdf934fc\">demonstration videos<\/a>\n<\/td>\n<td>Products formerly called SAPPHIRE and SQL*LIMS.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabWare,_Inc.\" title=\"LabWare, Inc.\" class=\"wiki-link\" data-key=\"34254ba2e2bbcd4ce616eba66db7d2f6\">LabWare, Inc.<\/a>\n<\/td>\n<td>LabWare LIMS, LabWare GROW\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabWare,_Inc.#Pricing\" title=\"LabWare, Inc.\" class=\"wiki-link\" data-key=\"cea54ac0a6799eecea49e37fe91ab98c\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/LabWare,_Inc.#Demonstration_videos_and_other_media\" title=\"LabWare, Inc.\" class=\"wiki-link\" data-key=\"ee2a01300383cb5bc6121c67231f129d\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labworks,_LLC\" title=\"Labworks, LLC\" class=\"wiki-link\" data-key=\"f8002e79393a927d6653e3e51b8bd71d\">Labworks, LLC<\/a>\n<\/td>\n<td>Labworks\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Bought LABWORKS from <a href=\"https:\/\/www.limswiki.org\/index.php\/PerkinElmer_Inc.\" title=\"PerkinElmer Inc.\" class=\"wiki-link\" data-key=\"dabda40785b60866d056709e611512f8\">PerkinElmer Inc.<\/a> in May 2016.<sup id=\"rdp-ebb-cite_ref-LWPressAcq_19-0\" class=\"reference\"><a href=\"#cite_note-LWPressAcq-19\">[19]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Lenava_Engineering_Group_Ltd.\" title=\"Lenava Engineering Group Ltd.\" class=\"wiki-link\" data-key=\"9a4fa4f037747acb99e0dbf806466215\">Lenava Engineering Group Ltd.<\/a>\n<\/td>\n<td>Lenava LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LETEC_SARL\" title=\"LETEC SARL\" class=\"wiki-link\" data-key=\"bab775850d59a541b2eb8b497d1f687d\">LETEC SARL<\/a>\n<\/td>\n<td>Tetraed LIMS\n<\/td>\n<td>No\n<\/td>\n<td>France\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Lex_Software_Solutions\" title=\"Lex Software Solutions\" class=\"wiki-link\" data-key=\"0ff19e36209b548737c684244eb00983\">Lex Software Solutions<\/a>\n<\/td>\n<td>Manage!\n<\/td>\n<td>Yes (customer request)\n<\/td>\n<td>Turkey\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Lex_Software_Solutions#Demonstration_videos_and_other_media\" title=\"Lex Software Solutions\" class=\"wiki-link\" data-key=\"38c6abd27e3aac92a6aa03731ad11e56\">Screenshots<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LGC_Limited\" title=\"LGC Limited\" class=\"wiki-link\" data-key=\"2e118ff5db549327b385b23687a34c5f\">LGC Limited<\/a>\n<\/td>\n<td>Kraken\n<\/td>\n<td>No\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LIMS_at_work_GmbH\" title=\"LIMS at work GmbH\" class=\"wiki-link\" data-key=\"af16920695787d9a5ff78d6fad5087ad\">LIMS at work GmbH<\/a>\n<\/td>\n<td>Labmatica LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Lims%2BWARE\" title=\"Lims+WARE\" class=\"wiki-link\" data-key=\"81ea1130aa24f6a1a62765907179e62a\">lims+WARE<\/a>\n<\/td>\n<td>lims+WARE\/ASP, \/Networks,<br \/>\/Results, \/UNIX\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Limseo_SARL\" title=\"Limseo SARL\" class=\"wiki-link\" data-key=\"2d7026e7dca779a411cf3e1ec3a2eccb\">Limseo SARL<\/a>\n<\/td>\n<td>Solution Laboratoire\n<\/td>\n<td>No\n<\/td>\n<td>France\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LIMSey,_LLC\" title=\"LIMSey, LLC\" class=\"wiki-link\" data-key=\"b64d89bb9ca21dc11f111bf347749c09\">LIMSey, LLC<\/a>\n<\/td>\n<td>LIMSey\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Locasoft_SARL\" title=\"Locasoft SARL\" class=\"wiki-link\" data-key=\"bc4b486fb76ad837407b05f5f17c30b5\">Locasoft SARL<\/a>\n<\/td>\n<td>LIMS.FR\n<\/td>\n<td>Yes\n<\/td>\n<td>France\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Loc@soft#Demonstration_videos_and_other_media\" class=\"mw-redirect wiki-link\" title=\"Loc@soft\" data-key=\"4cbd2659961bf21436318e4c64b81aa9\">Demonstration videos<\/a>\n<\/td>\n<td>Product changed names in 2019 from Lims.net to LIMS.FR.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Logiq_Innovations,_Inc.\" title=\"Logiq Innovations, Inc.\" class=\"wiki-link\" data-key=\"02ba9d5b040cbc7cc3724743c1633673\">Logiq Innovations, Inc.<\/a>\n<\/td>\n<td>LabPlus\n<\/td>\n<td>No\n<\/td>\n<td>Canada\n<\/td>\n<td>\n<\/td>\n<td>LabPlus formerly a product of <a href=\"https:\/\/www.limswiki.org\/index.php\/LabPlus_Technologies,_Inc.\" title=\"LabPlus Technologies, Inc.\" class=\"wiki-link\" data-key=\"b46d2d49c22e933005600c78c6658b15\">LabPlus Technologies<\/a>.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LogicaSoft_SPRL\" title=\"LogicaSoft SPRL\" class=\"wiki-link\" data-key=\"22e7c977c839746f3c6dabab8d977544\">LogicaSoft SPRL<\/a>\n<\/td>\n<td>Odoo LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>Belgium\n<\/td>\n<td>\n<\/td>\n<td>A LIMS built on open-source <a href=\"https:\/\/www.limswiki.org\/index.php\/Odoo\" title=\"Odoo\" class=\"wiki-link\" data-key=\"5cac9161a3b0e84673ecbc1dae1f085c\">Odoo<\/a> ERP\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LTech_Australia_Pty._Ltd.\" title=\"LTech Australia Pty. Ltd.\" class=\"wiki-link\" data-key=\"86040fd978904dd91e9d172161d30551\">LTech Australia Pty. Ltd.<\/a>\n<\/td>\n<td>Lims1\n<\/td>\n<td>No\n<\/td>\n<td>Australia\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Lyons_Information_Systems,_Inc.\" title=\"Lyons Information Systems, Inc.\" class=\"wiki-link\" data-key=\"7cccf271353de3644153142e157e743c\">Lyons Information Systems, Inc.<\/a>\n<\/td>\n<td>LLMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/M-Tech_International,_Inc.\" title=\"M-Tech International, Inc.\" class=\"wiki-link\" data-key=\"5d6e73c0ba8f00024396ffb83a07f3ce\">M-Tech International, Inc.<\/a>\n<\/td>\n<td>CAT<sup>2<\/sup> LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Malvern_Panalytical_BV\" title=\"Malvern Panalytical BV\" class=\"wiki-link\" data-key=\"b8f8822e61d5f2423acd7be77ec8a07a\">Malvern Panalytical BV<\/a>\n<\/td>\n<td>SPARCS\n<\/td>\n<td>No\n<\/td>\n<td>Netherlands\n<\/td>\n<td>\n<\/td>\n<td>Previously known as <a href=\"https:\/\/www.limswiki.org\/index.php\/PANalytical_BV\" title=\"PANalytical BV\" class=\"wiki-link\" data-key=\"c738b326f9fbdea25924896093918034\">PANalytical BV<\/a>.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/MAQSIMA_GmbH\" title=\"MAQSIMA GmbH\" class=\"wiki-link\" data-key=\"d0ab62789b2032f48270bec787bf5040\">MAQSIMA GmbH<\/a>\n<\/td>\n<td>MAQSIMA LAB+\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Mci_IT_Pty._Ltd.\" title=\"Mci IT Pty. Ltd.\" class=\"wiki-link\" data-key=\"036dad02433d5334a69c80a4aec57e19\">Mci IT Pty. Ltd.<\/a>\n<\/td>\n<td>Cloud Solutions Suite\n<\/td>\n<td>Yes\n<\/td>\n<td>South Africa\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Mci_IT_Pty._Ltd.#Pricing\" title=\"Mci IT Pty. Ltd.\" class=\"wiki-link\" data-key=\"3e52c1df857246b791055439576551b1\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Mci_IT_Pty._Ltd.#Demonstration_videos_and_other_media\" title=\"Mci IT Pty. Ltd.\" class=\"wiki-link\" data-key=\"7c38a38efadf25b061d451ca9bd52354\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/MEDEORA_GmbH\" title=\"MEDEORA GmbH\" class=\"wiki-link\" data-key=\"fec60057fe1be679c352bf03797e6d93\">MEDEORA GmbH<\/a>\n<\/td>\n<td>BioArchive\n<\/td>\n<td>Yes\n<\/td>\n<td>Germany\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/MEDEORA_GmbH#Pricing\" title=\"MEDEORA GmbH\" class=\"wiki-link\" data-key=\"b9ef9091f8f0374aa3b3821af31c886a\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/MEDEORA_GmbH#Demonstration_videos_and_other_media\" title=\"MEDEORA GmbH\" class=\"wiki-link\" data-key=\"67d5d4d50acf34c36410c688d8d3f216\">demonstration videos<\/a>\n<\/td>\n<td>Biobanking LIMS\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Medpace,_Inc.\" title=\"Medpace, Inc.\" class=\"wiki-link\" data-key=\"efa3eac6f03b53cbe5345c4c72035f2f\">Medpace, Inc.<\/a>\n<\/td>\n<td>ClinTrak Lab\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Clinical research LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Megaware,_Inc.\" title=\"Megaware, Inc.\" class=\"wiki-link\" data-key=\"a52ef9450a46f4837c961a9632de36cb\">Megaware, Inc.<\/a>\n<\/td>\n<td>LIAS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Methodiq,_LLC\" title=\"Methodiq, LLC\" class=\"wiki-link\" data-key=\"98ff5a76136be892450cea600e521452\">Methodiq, LLC<\/a>\n<\/td>\n<td>custom LIMS development\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Microcline_Projects\" title=\"Microcline Projects\" class=\"wiki-link\" data-key=\"c5afbbd2c55b0e9d64ae87808eae9d57\">Microcline Projects<\/a>\n<\/td>\n<td>Labosaurus\n<\/td>\n<td>Yes\n<\/td>\n<td>Canada\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Microcline_Projects#Pricing\" title=\"Microcline Projects\" class=\"wiki-link\" data-key=\"68e55d39f288c745181dffdf6e643270\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ML_Consulting_Technologies,_LLC\" title=\"ML Consulting Technologies, LLC\" class=\"wiki-link\" data-key=\"368f0fd742f11b081ebb183ffddaf780\">ML Consulting Technologies, LLC<\/a>\n<\/td>\n<td>WeLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ML_Consulting_Technologies,_LLC#Pricing\" title=\"ML Consulting Technologies, LLC\" class=\"wiki-link\" data-key=\"6bec3b53856d52617720540899baa6c2\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/ML_Consulting_Technologies,_LLC#Demonstration_videos_and_other_media\" title=\"ML Consulting Technologies, LLC\" class=\"wiki-link\" data-key=\"c611d2a22103df6a83292e2b1878be52\">demonstration videos<\/a>\n<\/td>\n<td>Free quality control LIMS for small labs\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Modul-Bio_SAS\" title=\"Modul-Bio SAS\" class=\"wiki-link\" data-key=\"215204029957f77145f7f33825b7b895\">Modul-Bio SAS<\/a>\n<\/td>\n<td>MBioLIMS\n<\/td>\n<td>No\n<\/td>\n<td>France\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Motto_Systems_Pvt._Ltd.\" title=\"Motto Systems Pvt. Ltd.\" class=\"wiki-link\" data-key=\"e3d5693c54d3fd39636f46040d3d96b3\">Motto Systems Pvt. Ltd.<\/a>\n<\/td>\n<td>GMPPro LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>India\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Motto_Systems_Pvt._Ltd.#Demonstration_videos_and_other_media\" title=\"Motto Systems Pvt. Ltd.\" class=\"wiki-link\" data-key=\"a8570fabc229299a8b3f723cb0a6db00\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Mukon_Informatics_(Pty)_Ltd.\" title=\"Mukon Informatics (Pty) Ltd.\" class=\"wiki-link\" data-key=\"ec125a5b3ab02fc9c8bf5f2ff5b97130\">Mukon Informatics (Pty) Ltd.<\/a>\n<\/td>\n<td>Skylims\n<\/td>\n<td>No\n<\/td>\n<td>South Africa\n<\/td>\n<td>\n<\/td>\n<td>Formerly <a href=\"https:\/\/www.limswiki.org\/index.php\/Mukon_CC\" title=\"Mukon CC\" class=\"wiki-link\" data-key=\"b604fb64c1a6ba2513ec967502c1a74e\">Mukon CC<\/a>. LIS marketed as a LIMS.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Myfab\" title=\"Myfab\" class=\"wiki-link\" data-key=\"8a38df925da2878f2cc3c0db35022429\">Myfab<\/a>\n<\/td>\n<td>Myfab LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Sweden\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/National_Agribusiness_Technology_Center\" title=\"National Agribusiness Technology Center\" class=\"wiki-link\" data-key=\"cd7ca99cd5e1164dfb3a2bde97404ec9\">National Agribusiness Technology Center<\/a>\n<\/td>\n<td>USALIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/National_Agribusiness_Technology_Center#Pricing\" title=\"National Agribusiness Technology Center\" class=\"wiki-link\" data-key=\"3ceae099f19ac0bc2d01d154feeaa82d\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/National_Cancer_Institute\" title=\"National Cancer Institute\" class=\"wiki-link\" data-key=\"281916a9fbd28f1e14ba3a07ff64abc8\">National Cancer Institute<\/a>\n<\/td>\n<td>caLIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/National_Cancer_Institute#Pricing\" title=\"National Cancer Institute\" class=\"wiki-link\" data-key=\"63e720165dc44b5d966e573eb5eb52f7\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Nexactly_AI_Solutions_Pvt._Ltd.\" title=\"Nexactly AI Solutions Pvt. Ltd.\" class=\"wiki-link\" data-key=\"a726e81cd72409bfb71d227e9deb249c\">Nexactly AI Solutions Pvt. Ltd.<\/a>\n<\/td>\n<td>Nexactly LIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Nexix,_Inc.\" title=\"Nexix, Inc.\" class=\"wiki-link\" data-key=\"cf8274b1e032129f3ae6fb1c3e1c8778\">Nexix, Inc.<\/a>\n<\/td>\n<td>Nexix LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>Canada\n<\/td>\n<td>\n<\/td>\n<td>Designed for PCR\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Nippon_Control_System_Corporation\" title=\"Nippon Control System Corporation\" class=\"wiki-link\" data-key=\"0eae9c1ded7e4ebdd3d84e87df7dbd0e\">Nippon Control System Corporation<\/a>\n<\/td>\n<td>SimpDoc\n<\/td>\n<td>No\n<\/td>\n<td>Japan\n<\/td>\n<td>\n<\/td>\n<td>Discontinued SimpLabo in May or June 2018.<br \/>Still offering SimpDoc, per company.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Novatek_International\" title=\"Novatek International\" class=\"wiki-link\" data-key=\"85ba3d679d422a871106d090e2cdd0b0\">Novatek International<\/a>\n<\/td>\n<td>NOVA-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Canada\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Oasis_Infotech_Pvt._Ltd.\" title=\"Oasis Infotech Pvt. Ltd.\" class=\"wiki-link\" data-key=\"7f8d866eaa35b3f256c290d6079afc78\">Oasis Infotech Pvt. Ltd.<\/a>\n<\/td>\n<td>EnviroLIMS EWM, LIMZ-RD,<br \/>OasisLIMS, True-LIMZ CTL\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Ocimum_Biosolutions_Ltd.\" title=\"Ocimum Biosolutions Ltd.\" class=\"wiki-link\" data-key=\"7910aaac6bdec6c2064f011e9a7cff8b\">Ocimum Biosolutions Ltd.<\/a>\n<\/td>\n<td>Biotracker LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Odysis_SA\" title=\"Odysis SA\" class=\"wiki-link\" data-key=\"c2d0e9c0d904948b53d63a2bb12defb5\">Odysis SA<\/a>\n<\/td>\n<td>myLIMS\n<\/td>\n<td>No\n<\/td>\n<td>Switzerland\n<\/td>\n<td>\n<\/td>\n<td>Not to be confused with <a href=\"https:\/\/www.limswiki.org\/index.php\/Labsoft_Tecnologia_Ltda.\" title=\"Labsoft Tecnologia Ltda.\" class=\"wiki-link\" data-key=\"442903b6b6e45f0bd21152b0cb522734\">Labsoft Tecnologia Limitada's<\/a> myLIMS product.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Online_LIMS_Canada_Limited\" title=\"Online LIMS Canada Limited\" class=\"wiki-link\" data-key=\"a457babb7723ed1966b0150631817143\">Online LIMS Canada Limited<\/a>\n<\/td>\n<td>OnLIMS\n<\/td>\n<td>No\n<\/td>\n<td>Canada\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/OnQ_Software_Pty._Ltd.\" title=\"OnQ Software Pty. Ltd.\" class=\"wiki-link\" data-key=\"1e7c67c27063b6a7f836cf9a802e42a0\">OnQ Software Pty. Ltd.<\/a>\n<\/td>\n<td>QLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>Australia\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Bika_LIMS\" title=\"Bika LIMS\" class=\"wiki-link\" data-key=\"daf3e2e28f594ad55c814ae802d43fcb\">Bika LIMS<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>See <a href=\"https:\/\/www.limswiki.org\/index.php\/Bika_Lab_Systems_(Pty)_Ltd.\" title=\"Bika Lab Systems (Pty) Ltd.\" class=\"wiki-link\" data-key=\"a39862cc41349265a37eb87242d3a628\">Bika Lab Systems (Pty) Ltd.<\/a> for more info.\n<\/td><\/tr>\n\n\n<tr>\n<td>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/National_Cancer_Institute#caBIG_Clinical_Trials.2C_caLIMS.2C_and_caTissue\" title=\"National Cancer Institute\" class=\"wiki-link\" data-key=\"44e856ec801242f68a4ef71d32f0f45e\">caLIMS<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>See <a href=\"https:\/\/www.limswiki.org\/index.php\/National_Cancer_Institute\" title=\"National Cancer Institute\" class=\"wiki-link\" data-key=\"281916a9fbd28f1e14ba3a07ff64abc8\">National Cancer Institute<\/a> for more info.\n<\/td><\/tr>\n\n\n<tr>\n<td>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ClinViro\" title=\"ClinViro\" class=\"wiki-link\" data-key=\"2b0b04f6f86788f0966853599743c210\">ClinViro<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>More information found on [<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/github.com\/hivdb\/clinviro\" target=\"_blank\">project page<\/a>].\n<\/td><\/tr>\n\n\n<tr>\n<td>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/GNomEx\" title=\"GNomEx\" class=\"wiki-link\" data-key=\"ffe2672873462be87660d574029bf8b2\">GNomEx<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>More information found on <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sourceforge.net\/projects\/gnomex\/\" target=\"_blank\">SourceForge.net<\/a>.\n<\/td><\/tr>\n\n\n<tr>\n<td>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/GNU_LIMS\" title=\"GNU LIMS\" class=\"wiki-link\" data-key=\"98c7163d23fcaef02b49ee28e8fc27c6\">GNU LIMS<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>More information found on <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/savannah.gnu.org\/projects\/lims\/\" target=\"_blank\">the project page<\/a>.\n<\/td><\/tr>\n\n\n<tr>\n<td>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LAMA\" title=\"LAMA\" class=\"wiki-link\" data-key=\"2e753d33ba23e297ab58d2850fda7f25\">LAMA<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>More information found on <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/launchpad.net\/mousedb\" target=\"_blank\">the project website<\/a>.\n<\/td><\/tr>\n\n\n<tr>\n<td>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Leaf_LIMS\" title=\"Leaf LIMS\" class=\"wiki-link\" data-key=\"f1a81768f4fa6996a79473fd71cef41a\">Leaf LIMS<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>More information found on <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/leaflims.github.io\/\" target=\"_blank\">the project website<\/a>.\n<\/td><\/tr>\n\n\n<tr>\n<td>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/MetaLIMS\" title=\"MetaLIMS\" class=\"wiki-link\" data-key=\"cbcda0d43003f11a36cb1ff6ef6380ca\">MetaLIMS<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>More information found on <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/github.com\/cheinle\/MetaLIMS\/wiki\" target=\"_blank\">the project website<\/a>.\n<\/td><\/tr>\n\n\n<tr>\n<td>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Open-LIMS\" title=\"Open-LIMS\" class=\"wiki-link\" data-key=\"a32e943ce983cd067b7f6208fa9dc3f5\">Open-LIMS<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>More information found on <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.open-lims.org\/home.html\" target=\"_blank\">the project website<\/a>.\n<\/td><\/tr>\n\n\n<tr>\n<td>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/OpenBIS\" title=\"OpenBIS\" class=\"wiki-link\" data-key=\"3bbca2b6be0c273677fc99a9474e49ec\">openBIS<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>More information found on <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cisd.ethz.ch\/software\/openBIS\" target=\"_blank\">the project website<\/a>.\n<\/td><\/tr>\n\n\n<tr>\n<td>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/OpenELIS\" title=\"OpenELIS\" class=\"wiki-link\" data-key=\"b11b00d1e7409d55b58e9f82204cc2a3\">OpenELIS<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>More information found on <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/openelis.org\/\" target=\"_blank\">the project website<\/a>.\n<\/td><\/tr>\n\n\n<tr>\n<td>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Krishagni_Solutions_Pvt._Ltd.#OpenSpecimen\" title=\"Krishagni Solutions Pvt. Ltd.\" class=\"wiki-link\" data-key=\"99433c93aed3a293faed918102ca61fa\">OpenSpecimen<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>More information found on the <a href=\"https:\/\/www.limswiki.org\/index.php\/Krishagni_Solutions_Pvt._Ltd.\" title=\"Krishagni Solutions Pvt. Ltd.\" class=\"wiki-link\" data-key=\"5fe10530cb5c78692f55c4ea486970f5\">Krishagni Solutions Pvt. Ltd.<\/a> page.\n<\/td><\/tr>\n\n\n<tr>\n<td>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Screensaver_HTS_LIMS\" title=\"Screensaver HTS LIMS\" class=\"wiki-link\" data-key=\"a128655ba7b671764c16eef4beef635e\">Screensaver HTS LIMS<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>More information found on <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sourceforge.net\/projects\/screensaver\/\" target=\"_blank\">SourceForge.net<\/a>.\n<\/td><\/tr>\n\n\n<tr>\n<td>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/SMITH\" title=\"SMITH\" class=\"wiki-link\" data-key=\"de4e2a9e63484e867d5d844c95afdedf\">SMITH<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>More information found on <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bitbucket.org\/yuriy_vaskin\/smith\/overview\" target=\"_blank\">Bitbucket<\/a>.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Open.Co_Srl\" title=\"Open.Co Srl\" class=\"wiki-link\" data-key=\"1ecf58c547005482dcec603fbe98b25d\">Open.Co Srl<\/a>\n<\/td>\n<td>ProLab.Q\n<\/td>\n<td>Yes\n<\/td>\n<td>Italy\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/OPTIMAL_SYSTEMS_GmbH\" title=\"OPTIMAL SYSTEMS GmbH\" class=\"wiki-link\" data-key=\"8e1061a40aa902ecc50bc03a1fdead99\">OPTIMAL SYSTEMS GmbH<\/a>\n<\/td>\n<td>enaio Laboratory Content Center\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Oracle_Corporation\" title=\"Oracle Corporation\" class=\"wiki-link\" data-key=\"e7c297d8baacdc1f11f4852085c4adc7\">Oracle Corporation<\/a>\n<\/td>\n<td>Oracle Health Sciences<br \/>Clinical Development Analytics\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Orsyx\" title=\"Orsyx\" class=\"wiki-link\" data-key=\"02db92596652a3dff6249fb6e0f11905\">Orsyx<\/a>\n<\/td>\n<td>eL@b\n<\/td>\n<td>No\n<\/td>\n<td>Israel\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Orsyx#Demonstration_videos_and_other_media\" title=\"Orsyx\" class=\"wiki-link\" data-key=\"8e7c79e900b7f5379571ccf7b0228aa1\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Ovation.io,_Inc.\" title=\"Ovation.io, Inc.\" class=\"wiki-link\" data-key=\"76a99c16e45c7c9bf00d41ea0c8f5e02\">Ovation.io, Inc.<\/a>\n<\/td>\n<td>Ovation LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Physion,_LLC#Demonstration_videos_and_other_media\" class=\"mw-redirect wiki-link\" title=\"Physion, LLC\" data-key=\"f4b490c022cc64d3746df9ea2846a3dc\">Demonstration videos<\/a>\n<\/td>\n<td>Company and product have undergone many name changes,<br \/>with \"Ovation\" the latest.\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Oy_Fision_Ltd.\" title=\"Oy Fision Ltd.\" class=\"wiki-link\" data-key=\"b95dca7fca017598d8cffef225513942\">Oy Fision Ltd.<\/a>\n<\/td>\n<td>Broadsight LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Finland\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Pardus_d.o.o.\" title=\"Pardus d.o.o.\" class=\"wiki-link\" data-key=\"71d78089a85664cb5dc9f5629fd7b2ad\">Pardus d.o.o.<\/a>\n<\/td>\n<td>eQMS::LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Croatia\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/PDS_Group_Holding_AG\" title=\"PDS Group Holding AG\" class=\"wiki-link\" data-key=\"5d5b50eaed79bd27056e0cde8c98aa1c\">PDS Group Holding AG<\/a>\n<\/td>\n<td>Ascentos\n<\/td>\n<td>Yes\n<\/td>\n<td>Switzerland\n<\/td>\n<td>\n<\/td>\n<td>Former products were PathData, ReproData, and ToxData.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Pdv-software_GmbH\" title=\"Pdv-software GmbH\" class=\"wiki-link\" data-key=\"b1b72d8c47b0fbf5e65f09b690343a8a\">pdv-software GmbH<\/a>\n<\/td>\n<td>pdv-lims 3\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Persistent_Systems_Ltd.\" title=\"Persistent Systems Ltd.\" class=\"wiki-link\" data-key=\"6c3d8b410fd38e788984edb3013ecbf6\">Persistent Systems Ltd.<\/a>\n<\/td>\n<td>ChemLMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>Acquired from <a href=\"https:\/\/www.limswiki.org\/index.php\/Agilent_Technologies,_Inc.\" title=\"Agilent Technologies, Inc.\" class=\"wiki-link\" data-key=\"dcea1a676a012bcbe3af9562dd17f8a0\">Agilent<\/a>.<sup id=\"rdp-ebb-cite_ref-20\" class=\"reference\"><a href=\"#cite_note-20\">[20]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Pharmaceuticals_Systems_International,_LLC\" title=\"Pharmaceuticals Systems International, LLC\" class=\"wiki-link\" data-key=\"0829df510af487e6c1c25456ccee22d4\">Pharmaceuticals Systems International, LLC<\/a>\n<\/td>\n<td>PSI\n<\/td>\n<td>Yes\n<\/td>\n<td>U.S.\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Pharmaceuticals_Systems_International,_LLC#Pricing\" title=\"Pharmaceuticals Systems International, LLC\" class=\"wiki-link\" data-key=\"87179d4189f3e7209fc7a5a5fcb24ac8\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Pharmaceuticals_Systems_International,_LLC#Demonstration_videos_and_other_media\" title=\"Pharmaceuticals Systems International, LLC\" class=\"wiki-link\" data-key=\"b6ef15af8ad93ee33f008c83b57acede\">demonstration videos<\/a>\n<\/td>\n<td>Cloud-based application suite that includes LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Phylum_SARL\" title=\"Phylum SARL\" class=\"wiki-link\" data-key=\"e21b96846fd1902fc316aa1c8b9ef920\">Phylum SARL<\/a>\n<\/td>\n<td>Phylum.Laboratoire\n<\/td>\n<td>No\n<\/td>\n<td>France\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/PiControl_Solutions,_LLC\" title=\"PiControl Solutions, LLC\" class=\"wiki-link\" data-key=\"8008f3675bc602f9f139fac1d1d06f37\">PiControl Solutions, LLC<\/a>\n<\/td>\n<td>PiLims\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Polisystem_Informatica_Srl\" title=\"Polisystem Informatica Srl\" class=\"wiki-link\" data-key=\"d4b211475439098bb3a6e83408b9534c\">Polisystem Informatica Srl<\/a>\n<\/td>\n<td>Analisi\n<\/td>\n<td>No\n<\/td>\n<td>Italy\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Pondpol_Group\" title=\"Pondpol Group\" class=\"wiki-link\" data-key=\"b9c90ca22041cc0cd7c8ff72d0a11352\">Pondpol Group<\/a>\n<\/td>\n<td>The rapid family of LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Thailand\n<\/td>\n<td>\n<\/td>\n<td>Five LIMS-like solutions covering multiple industries\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Porter_Lee_Corporation\" title=\"Porter Lee Corporation\" class=\"wiki-link\" data-key=\"06cee8a82c6423b6a687009a1908a27a\">Porter Lee Corporation<\/a>\n<\/td>\n<td>Crime Fighter BEAST\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Process_Solutions_Canada_Limited\" title=\"Process Solutions Canada Limited\" class=\"wiki-link\" data-key=\"892710da7ccb714de6700f70706ed2ae\">Process Solutions Canada Limited<\/a>\n<\/td>\n<td>LDMS\n<\/td>\n<td>No\n<\/td>\n<td>Canada\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Prog4biz_Software_Solutions_Ltd.\" title=\"Prog4biz Software Solutions Ltd.\" class=\"wiki-link\" data-key=\"283682b6685324f97ead780864abc03a\">Prog4biz Software Solutions Ltd.<\/a>\n<\/td>\n<td>BookitLab\n<\/td>\n<td>Yes\n<\/td>\n<td>Canada\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Progeny_Genetics,_LLC\" title=\"Progeny Genetics, LLC\" class=\"wiki-link\" data-key=\"c90e150c2a086a9e540af84a69890d2e\">Progeny Genetics, LLC<\/a>\n<\/td>\n<td>Progeny Clinical\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Progeny_Genetics,_LLC\" title=\"Progeny Genetics, LLC\" class=\"wiki-link\" data-key=\"c90e150c2a086a9e540af84a69890d2e\">Pricing<\/a>\n<\/td>\n<td>Some pricing available for Clinical.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Promadis_Pty._Ltd.\" title=\"Promadis Pty. Ltd.\" class=\"wiki-link\" data-key=\"a330d866e70c0b3d17dbf1dd095c6670\">Promadis Pty. Ltd.<\/a>\n<\/td>\n<td>Caseman\n<\/td>\n<td>No\n<\/td>\n<td>Australia\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Promium,_LLC\" title=\"Promium, LLC\" class=\"wiki-link\" data-key=\"bd099d6b29039ad59a849f38770d01cc\">Promium, LLC<\/a>\n<\/td>\n<td>Element LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Promium,_LLC#Pricing\" title=\"Promium, LLC\" class=\"wiki-link\" data-key=\"051e8fbafc953073a4e2a5117d8a4130\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Promium,_LLC#Demonstration_videos_and_other_media\" title=\"Promium, LLC\" class=\"wiki-link\" data-key=\"4c1a8ef9858079152932bcfaf9366701\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/PRYM-SOFT_Sp._z_o.o.\" title=\"PRYM-SOFT Sp. z o.o.\" class=\"wiki-link\" data-key=\"b1f0aeeaddc2a62055cc47f726790806\">PRYM-SOFT Sp. z o.o.<\/a>\n<\/td>\n<td>CleverLAB, PureLAB\n<\/td>\n<td>Yes\n<\/td>\n<td>Poland\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/PT_Digita_Scientia_Indonesia\" title=\"PT Digita Scientia Indonesia\" class=\"wiki-link\" data-key=\"d418c2c7f8e071b5e59dfb1d2efc14ea\">PT Digita Scientia Indonesia<\/a>\n<\/td>\n<td>OrbitaLIMS\n<\/td>\n<td>No\n<\/td>\n<td>Indonesia\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/QBench,_Inc.\" title=\"QBench, Inc.\" class=\"wiki-link\" data-key=\"46fc963298825b04f34f69e6c9f8bb61\">QBench, Inc.<\/a>\n<\/td>\n<td>QBench\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Junction_Concepts,_Inc.#Demonstration_videos_and_other_media\" title=\"Junction Concepts, Inc.\" class=\"wiki-link\" data-key=\"888134668306275ef34ecad38ec4ccb5\">Demonstration videos<\/a>\n<\/td>\n<td>Transferred from <a href=\"https:\/\/www.limswiki.org\/index.php\/Junction_Concepts,_Inc.\" title=\"Junction Concepts, Inc.\" class=\"wiki-link\" data-key=\"db728c00d9a437cf664e26d88af95fc4\">Junction Concepts, Inc.<\/a> in August 2022.<br \/>(Source: Personal correspondence)\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/QDA_SOLUTIONS_GmbH\" title=\"QDA SOLUTIONS GmbH\" class=\"wiki-link\" data-key=\"be5776632fa81cbe4d593d90dd5d11c0\">QDA SOLUTIONS GmbH<\/a>\n<\/td>\n<td>QDA LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Qualitype_GmbH\" title=\"Qualitype GmbH\" class=\"wiki-link\" data-key=\"bde56294c6e50189d1a4ddf65224214f\">Qualitype GmbH<\/a>\n<\/td>\n<td>Abetter LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/QUALIMS_SARL\" title=\"QUALIMS SARL\" class=\"wiki-link\" data-key=\"051d58aa853634ad48f2cd4331e8752b\">QUALIMS SARL<\/a>\n<\/td>\n<td>QUALIMS\n<\/td>\n<td>No\n<\/td>\n<td>France\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_Systems_International_Corporation\" title=\"Quality Systems International Corporation\" class=\"wiki-link\" data-key=\"c4341502a3ea1391b8944fd34c6931eb\">Quality Systems International Corporation<\/a>\n<\/td>\n<td>WinLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Quartz_Imaging_Corporation\" title=\"Quartz Imaging Corporation\" class=\"wiki-link\" data-key=\"234502b6f34dd7de4656f7d155a6e52c\">Quartz Imaging Corporation<\/a>\n<\/td>\n<td>Quartz LA-, FA-, and RE-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Canada\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Raddec_International_Ltd.\" title=\"Raddec International Ltd.\" class=\"wiki-link\" data-key=\"2769f2db7fd7ccb8a054fb2edd515046\">Raddec International Ltd.<\/a>\n<\/td>\n<td>Raddec-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United Kingdom\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Raddec_International_Ltd.#Demonstration_videos_and_other_media\" title=\"Raddec International Ltd.\" class=\"wiki-link\" data-key=\"21f676687d0af7dfcab6861b72c686b2\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Realistic_Computing,_Inc.\" title=\"Realistic Computing, Inc.\" class=\"wiki-link\" data-key=\"5922e7bff577776e69995a6a6e9242f0\">Realistic Computing, Inc.<\/a>\n<\/td>\n<td>eData Specialty LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Reston_Stable_Isotope_Laboratory\" title=\"Reston Stable Isotope Laboratory\" class=\"wiki-link\" data-key=\"24e0cb2f45ad2e368c1a6fe4634b503c\">Reston Stable Isotope Laboratory<\/a>\n<\/td>\n<td>LIMS for Lasers,<br \/>LIMS for Light Stable Isotopes\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Reston_Stable_Isotope_Laboratory#Pricing\" title=\"Reston Stable Isotope Laboratory\" class=\"wiki-link\" data-key=\"dbd7227f9a830c7aac190b20c7cc30fe\">Pricing<\/a>\n<\/td>\n<td>The RSIL is part of the U.S. Geological Survey.\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Revol_Software_Solutions,_LLC\" title=\"Revol Software Solutions, LLC\" class=\"wiki-link\" data-key=\"d1df92171e04a9a1768c70beb8e14bc4\">Revol Software Solutions, LLC<\/a>\n<\/td>\n<td>Revol LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Revol_Software_Solutions,_LLC#Pricing\" title=\"Revol Software Solutions, LLC\" class=\"wiki-link\" data-key=\"9d7fb8a7bb88cfda874856446d8728be\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Revol_Software_Solutions,_LLC#Demonstration_videos_and_other_media\" title=\"Revol Software Solutions, LLC\" class=\"wiki-link\" data-key=\"b2ee8a23bcc3421ceae536e154c2f578\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/RHAPSODY_Software_Solutions_GmbH\" title=\"RHAPSODY Software Solutions GmbH\" class=\"wiki-link\" data-key=\"bdd41bc35f7b255054550bf089d13e99\">RHAPSODY Software Solutions GmbH<\/a>\n<\/td>\n<td>RHAPSODY LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>Officially changed name from Softwaresysteme Keeve GmbH in February 2018.<sup id=\"rdp-ebb-cite_ref-CylexRhapsody_21-0\" class=\"reference\"><a href=\"#cite_note-CylexRhapsody-21\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-OHRSoftwaresysteme_22-0\" class=\"reference\"><a href=\"#cite_note-OHRSoftwaresysteme-22\">[22]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/RJ_Lee_Solutions,_LLC\" title=\"RJ Lee Solutions, LLC\" class=\"wiki-link\" data-key=\"dc9c2628e4981c01349a08ac18b73d97\">RJ Lee Solutions, LLC<\/a>\n<\/td>\n<td>THEMIS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/RockStep_Solutions,_Inc.\" title=\"RockStep Solutions, Inc.\" class=\"wiki-link\" data-key=\"3a0ddae4f0fe17aa02e38319491f9c65\">RockStep Solutions, Inc.<\/a>\n<\/td>\n<td>Climb\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/RockStep_Solutions,_Inc.#Demonstration_videos_and_other_media\" title=\"RockStep Solutions, Inc.\" class=\"wiki-link\" data-key=\"af4ff3a23ed47c7ae9ff7a48c5c45f73\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/S.G._Systems,_LLC\" title=\"S.G. Systems, LLC\" class=\"wiki-link\" data-key=\"f2074b973b29a3c2f66df9ec8bb9a20b\">S.G. Systems, LLC<\/a>\n<\/td>\n<td>V5 Traceability\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Manufacturing traceability software system with a LIMS module\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Sapio_Sciences,_LLC\" title=\"Sapio Sciences, LLC\" class=\"wiki-link\" data-key=\"c013f3c0c7c61713ca1d19812d6aac24\">Sapio Sciences, LLC<\/a>\n<\/td>\n<td>Sapio Bioanalytical LIMS, Clinical<br \/>LIMS, Histopathology LIMS, NGS LIMS,<br \/>Research LIMS, and Stability LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Sapio_Sciences,_LLC#Demonstration_videos_and_other_media\" title=\"Sapio Sciences, LLC\" class=\"wiki-link\" data-key=\"b12696895a4a128809a5daf8c7af6a9b\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Satya_Sistemas_Ltda.\" title=\"Satya Sistemas Ltda.\" class=\"wiki-link\" data-key=\"70fc96cb48ae015f70e1dd0187ef528b\">Satya Sistemas Ltda.<\/a>\n<\/td>\n<td>Flux<sup>2<\/sup>\n<\/td>\n<td>No\n<\/td>\n<td>Brazil\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Scigilian_Software,_Inc.\" title=\"Scigilian Software, Inc.\" class=\"wiki-link\" data-key=\"6200ef46763dcd0565ceab5c96819a0f\">Scigilian Software, Inc.<\/a>\n<\/td>\n<td>Scigilian\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ScienTek_Software,_Inc.\" title=\"ScienTek Software, Inc.\" class=\"wiki-link\" data-key=\"8ff15df40c66090ef018f59a35d759dd\">ScienTek Software, Inc.<\/a>\n<\/td>\n<td>iStability LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>LIMS designed for pharmaceutical stability testing programs<br \/>and stability test management\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Semaphore_Solutions,_Inc.\" title=\"Semaphore Solutions, Inc.\" class=\"wiki-link\" data-key=\"d48f367fd2b945bd3aa933be317fc569\">Semaphore Solutions, Inc.<\/a>\n<\/td>\n<td>Labbit, custom LIMS development\n<\/td>\n<td>No\n<\/td>\n<td>Canada\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Sempai_Consulting_Ltd._%26_Co._KG\" title=\"Sempai Consulting Ltd. & Co. KG\" class=\"wiki-link\" data-key=\"54c6ffcea91aa20e8732a6fe61836830\">Sempai Consulting Ltd. & Co. KG<\/a>\n<\/td>\n<td>scarabPLUS\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>A pharmaceutical ERP that fully integrates a LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Shimadzu_Corporation\" title=\"Shimadzu Corporation\" class=\"wiki-link\" data-key=\"b55dff14f2cd33d62456eb1653d4cad5\">Shimadzu Corporation<\/a>\n<\/td>\n<td>LIMSsolution\n<\/td>\n<td>No\n<\/td>\n<td>Japan\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Siemens_AG\" title=\"Siemens AG\" class=\"wiki-link\" data-key=\"02158f083dff6f082f3b17048612608d\">Siemens AG<\/a>\n<\/td>\n<td>Formulated Product Design, SIMATIC IT Unilab\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Sigmen_Technologies_Solutions_Pvt._Ltd.\" title=\"Sigmen Technologies Solutions Pvt. Ltd.\" class=\"wiki-link\" data-key=\"fede823bb630d1a4649316762545f104\">Sigmen Technologies Solutions Pvt. Ltd.<\/a>\n<\/td>\n<td>Sigma LIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Simploud_Limited\" title=\"Simploud Limited\" class=\"wiki-link\" data-key=\"69177b20566e87c662485037439a309e\">Simploud Limited<\/a>\n<\/td>\n<td>Simplab\n<\/td>\n<td>No\n<\/td>\n<td>Israel\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Simploud_Limited#Pricing\" title=\"Simploud Limited\" class=\"wiki-link\" data-key=\"2c4734d8b66bdfce224e705a81b4b700\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Simploud_Limited#Demonstration_videos_and_other_media\" title=\"Simploud Limited\" class=\"wiki-link\" data-key=\"49b165aedf2c3be4f4b595be052e89f2\">demonstration videos<\/a>\n<\/td>\n<td>Salesforce-based LIMS\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/SLCLAB_Inform%C3%A1tica_SL\" title=\"SLCLAB Inform\u00e1tica SL\" class=\"wiki-link\" data-key=\"79400a95a2c7594421f69d99c5b9182c\">SLCLAB Inform\u00e1tica SL<\/a>\n<\/td>\n<td>ALFA21, Zendo LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>Spain\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/SLCLAB_Inform%C3%A1tica_SL#Pricing\" title=\"SLCLAB Inform\u00e1tica SL\" class=\"wiki-link\" data-key=\"6b4b410e66529b19450aa937ec2bb694\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/SLCLAB_Inform%C3%A1tica_SL#Demonstration_videos_and_other_media\" title=\"SLCLAB Inform\u00e1tica SL\" class=\"wiki-link\" data-key=\"3aa63b12319eeecf90e1739c1515d688\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Sofcom_(Private)_Limited\" title=\"Sofcom (Private) Limited\" class=\"wiki-link\" data-key=\"16fc128ce5699539eea4669f8acf80bc\">Sofcom (Private) Limited<\/a>\n<\/td>\n<td>Spectrum\n<\/td>\n<td>No\n<\/td>\n<td>Pakistan\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Soft_Computer_Consultants,_Inc.\" title=\"Soft Computer Consultants, Inc.\" class=\"wiki-link\" data-key=\"9d43b43c0cbd8d15ecd440869b7c4f93\">Soft Computer Consultants, Inc.<\/a>\n<\/td>\n<td>SoftLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Software_for_Life_Sciences_BV\" title=\"Software for Life Sciences BV\" class=\"wiki-link\" data-key=\"777772d1ee8dba05f12372ef2a1d5d5d\">Software for Life Sciences BV<\/a>\n<\/td>\n<td>LabScores\n<\/td>\n<td>No\n<\/td>\n<td>Netherlands\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Software_for_Life_Sciences_BV#Demonstration_videos_and_other_media\" title=\"Software for Life Sciences BV\" class=\"wiki-link\" data-key=\"ce9e6db1acbcddeb6501279d7e6cc88c\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Software_Point_Oy\" title=\"Software Point Oy\" class=\"wiki-link\" data-key=\"0b0bf7c15cc73acc0d896a87fad62e8c\">Software Point Oy<\/a>\n<\/td>\n<td>LabVantage Medical Suite,<br \/>Enterprise, and Express\n<\/td>\n<td>Yes\n<\/td>\n<td>Finland\n<\/td>\n<td>\n<\/td>\n<td>Acquired by <a href=\"https:\/\/www.limswiki.org\/index.php\/LABVANTAGE_Solutions,_Inc.\" class=\"mw-redirect wiki-link\" title=\"LABVANTAGE Solutions, Inc.\" data-key=\"0220767e0fd8cb7b9e78e3e8d3b7691d\">LABVANTAGE<\/a> in April 2011.<sup id=\"rdp-ebb-cite_ref-23\" class=\"reference\"><a href=\"#cite_note-23\">[23]<\/a><\/sup> C5 LIMS was renamed to<br \/>\"LABVANTAGE Medical Suite\" in December 2012.<sup id=\"rdp-ebb-cite_ref-24\" class=\"reference\"><a href=\"#cite_note-24\">[24]<\/a><\/sup> Former products:<br \/> TasteBOSS and WilabLIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Sorenson_Forensics,_LLC\" title=\"Sorenson Forensics, LLC\" class=\"wiki-link\" data-key=\"55e46421854fc7f7715ff762928ddff7\">Sorenson Forensics, LLC<\/a>\n<\/td>\n<td>eDNA LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Forensic LIMS\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/SpecPage_AG\" title=\"SpecPage AG\" class=\"wiki-link\" data-key=\"37b2b972c494d8a61827b221da4e7f13\">SpecPage AG<\/a>\n<\/td>\n<td>SpecLIMS\n<\/td>\n<td>No\n<\/td>\n<td>Switzerland\n<\/td>\n<td>\n<\/td>\n<td>Previously known as <a href=\"https:\/\/www.limswiki.org\/index.php\/Object_Solutions_Software_AG\" title=\"Object Solutions Software AG\" class=\"wiki-link\" data-key=\"b11c29a5fd0a1d07f330691af25bb903\">Object Solutions Software AG<\/a>.<sup id=\"rdp-ebb-cite_ref-OSArch1_25-0\" class=\"reference\"><a href=\"#cite_note-OSArch1-25\">[25]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SPArch1_26-0\" class=\"reference\"><a href=\"#cite_note-SPArch1-26\">[26]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Spectra_QEST_Australia_Pty._Ltd.\" title=\"Spectra QEST Australia Pty. Ltd.\" class=\"wiki-link\" data-key=\"33a365c4cf579f9920d572988a773400\">Spectra QEST Australia Pty. Ltd.<\/a>\n<\/td>\n<td>QESTField, QESTLab\n<\/td>\n<td>No\n<\/td>\n<td>Australia\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/StackWave,_LLC\" title=\"StackWave, LLC\" class=\"wiki-link\" data-key=\"97159535fdde6db4ac2bd492ef4cf532\">StackWave, LLC<\/a>\n<\/td>\n<td>StackWave Affinity LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Stanford_University_School_of_Medicine\" title=\"Stanford University School of Medicine\" class=\"wiki-link\" data-key=\"dcdf822be269ca41650360da6959efdf\">Stanford University School of Medicine<\/a>\n<\/td>\n<td>MendeLIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/STARLIMS_Corporation\" title=\"STARLIMS Corporation\" class=\"wiki-link\" data-key=\"9564e6e2ab70cd1ad0ae68d1ca215524\">STARLIMS Corporation<\/a>\n<\/td>\n<td>STARLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/STARLIMS_Corporation#Pricing\" title=\"STARLIMS Corporation\" class=\"wiki-link\" data-key=\"b7f3c45b569fba80aef5f8ba2c48c43a\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/STARLIMS_Corporation#Demonstration_videos_and_other_media\" title=\"STARLIMS Corporation\" class=\"wiki-link\" data-key=\"20b5212f23fe9ecd40281aa4a1ecd45e\">demonstration videos<\/a>\n<\/td>\n<td>Formerly Abbot Informatics Corporation.\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Stelsel_Software_Technologies_Pvt._Ltd.\" title=\"Stelsel Software Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"9834d5981c78befde7959feab84041d4\">Stelsel Software Technologies Pvt. Ltd.<\/a>\n<\/td>\n<td>NABL LIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/TechWare_Incorporated\" title=\"TechWare Incorporated\" class=\"wiki-link\" data-key=\"e8c3bc574a2b0e04e465cd45e496e4c6\">TechWare Incorporated<\/a>\n<\/td>\n<td>Logbook Discovery,<br \/>TechWare MainTrac\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Telesphorus_Consulting_Ltd.\" title=\"Telesphorus Consulting Ltd.\" class=\"wiki-link\" data-key=\"81a23996367fc0e023e4ea6f95706a3d\">Telesphorus Consulting Ltd.<\/a>\n<\/td>\n<td>gemLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/The_Edge_Software_Consultancy_Ltd.\" title=\"The Edge Software Consultancy Ltd.\" class=\"wiki-link\" data-key=\"8bba6fa76abd035e8e7d8c09f0d5ab19\">The Edge Software Consultancy Ltd.<\/a>\n<\/td>\n<td>BioRails LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United Kingdom\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/The_Edge_Software_Consultancy_Ltd.#Pricing\" title=\"The Edge Software Consultancy Ltd.\" class=\"wiki-link\" data-key=\"7a0bf905bae8a3c6f29b12888b9b8bb7\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/The_Edge_Software_Consultancy_Ltd.#Demonstration_videos_and_other_media\" title=\"The Edge Software Consultancy Ltd.\" class=\"wiki-link\" data-key=\"dd20eba8b08a2a01c661d0276d5a5df1\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Thermo_Scientific\" title=\"Thermo Scientific\" class=\"wiki-link\" data-key=\"e914753f99d483d4577b35fed71b3c94\">Thermo Fisher Scientific<\/a>\n<\/td>\n<td>Core LIMS, Nautilus, SampleManager, Watson\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Thermo_Scientific#Demonstration_videos_and_other_media\" title=\"Thermo Scientific\" class=\"wiki-link\" data-key=\"bc9c81191f00133ab2b7f284f692dfd9\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Third_Wave_Analytics,_Inc.\" title=\"Third Wave Analytics, Inc.\" class=\"wiki-link\" data-key=\"337ec8bf9e153e3ab81930dd7727b2c9\">Third Wave Analytics, Inc.<\/a>\n<\/td>\n<td>Lockbox LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Third_Wave_Analytics,_Inc.#Pricing\" title=\"Third Wave Analytics, Inc.\" class=\"wiki-link\" data-key=\"fc8cbe42b58535a022437a713638998b\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Third_Wave_Analytics,_Inc.#Demonstration_videos_and_other_media\" title=\"Third Wave Analytics, Inc.\" class=\"wiki-link\" data-key=\"e61411cba825a570f87ed7b29ba9dcb3\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Title21_Health_Solutions,_Inc.\" title=\"Title21 Health Solutions, Inc.\" class=\"wiki-link\" data-key=\"9d283785c774cc06f2bd63f59117f495\">Title21 Health Solutions, Inc.<\/a>\n<\/td>\n<td>Cellular Therapy Solution\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Title21_Health_Solutions,_Inc.#Demonstration_videos_and_other_media\" title=\"Title21 Health Solutions, Inc.\" class=\"wiki-link\" data-key=\"01707be9e978af9994704560ff793501\">Demonstration videos<\/a>\n<\/td>\n<td>A LIMS with a focus on cellular therapy\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Trace_First_Ltd.\" title=\"Trace First Ltd.\" class=\"wiki-link\" data-key=\"e01d6019719df1675a8c5b3d1ba0be06\">Trace First Ltd.<\/a>\n<\/td>\n<td>CoreOne for Labs\n<\/td>\n<td>Yes\n<\/td>\n<td>Ireland\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/TraxStar_Technologies,_Inc.\" title=\"TraxStar Technologies, Inc.\" class=\"wiki-link\" data-key=\"8f0ac30eb5f9495da9c46e721600453f\">TraxStar Technologies, Inc.<\/a>\n<\/td>\n<td>QATrax LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/TraxStar_Technologies,_Inc.#Demonstration_videos_and_other_media\" title=\"TraxStar Technologies, Inc.\" class=\"wiki-link\" data-key=\"522f206429aefa96fe67692a09799f57\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Tribal_Software,_Inc.\" title=\"Tribal Software, Inc.\" class=\"wiki-link\" data-key=\"fa8337face2e6e7aa027981d7519933a\">Tribal Software, Inc.<\/a>\n<\/td>\n<td>LIMS Lyte, Tribal-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Triestram_%26_Partner_GmbH\" title=\"Triestram & Partner GmbH\" class=\"wiki-link\" data-key=\"18c9d35d9f4d223cfa8c81b081105780\">Triestram & Partner GmbH<\/a>\n<\/td>\n<td>lisa.lims\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Trilogy_Group_Limited\" title=\"Trilogy Group Limited\" class=\"wiki-link\" data-key=\"134fe68f17f70cbdb8c2b78b42d62c03\">Trilogy Group Limited<\/a>\n<\/td>\n<td>TAPS\n<\/td>\n<td>No\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/TRUST_Infotech_Electronics,_LLC\" title=\"TRUST Infotech Electronics, LLC\" class=\"wiki-link\" data-key=\"2aba9749cdfff98e61897ef6759c82f4\">TRUST Infotech Electronics, LLC<\/a>\n<\/td>\n<td>TRUST LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United Arab Emirates\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/TQ_Technology_Pvt._Ltd.\" title=\"TQ Technology Pvt. Ltd.\" class=\"wiki-link\" data-key=\"3da755f9ce5759e7b09a281eb9d94303\">TQ Technology Pvt. Ltd.<\/a>\n<\/td>\n<td>TQLIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Uncountable,_Inc.\" title=\"Uncountable, Inc.\" class=\"wiki-link\" data-key=\"0c3ef9a11ed4232071f95a09db2af609\">Uncountable, Inc.<\/a>\n<\/td>\n<td>Uncountable\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Uncountable,_Inc.#Demonstration_videos_and_other_media\" title=\"Uncountable, Inc.\" class=\"wiki-link\" data-key=\"274c26dda7de58e6cbc3dbab608677fd\">Demonstration videos<\/a>\n<\/td>\n<td>LIMS- and ELN-like platform for chemical R&D\n<\/td><\/tr>\n \n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/United_States_Environmental_Protection_Agency\" title=\"United States Environmental Protection Agency\" class=\"wiki-link\" data-key=\"877b052e12328aa52f6f7c3f2d56f99a\">U.S. EPA<\/a>\n<\/td>\n<td>Scribe\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/United_States_Environmental_Protection_Agency#Pricing\" title=\"United States Environmental Protection Agency\" class=\"wiki-link\" data-key=\"2ed4892023f0593dc5d1147e5bbe3469\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Up_to_data_sales_and_services_GmbH\" title=\"Up to data sales and services GmbH\" class=\"wiki-link\" data-key=\"5c1e4566fa9e4e56107be79e86a9d284\">up to data sales and services GmbH<\/a>\n<\/td>\n<td>up2Lims\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Valdata_Systems_USA,_Inc.\" title=\"Valdata Systems USA, Inc.\" class=\"wiki-link\" data-key=\"6e019a9aa55b6d3039de9420a857e6bd\">Valdata Systems USA, Inc.<\/a>\n<\/td>\n<td>Chemical Management System\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Valdata_Systems_USA,_Inc.#Demonstration_videos_and_other_media\" title=\"Valdata Systems USA, Inc.\" class=\"wiki-link\" data-key=\"6bbc20d9f186bdc3c3727a9f88469aed\">Demonstration videos<\/a>\n<\/td>\n<td>Suite of modules, including a LIMS, for manufacturing\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Veeva_Systems,_Inc.\" title=\"Veeva Systems, Inc.\" class=\"wiki-link\" data-key=\"c14a34119387ec53d99f7104b32b1cbf\">Veeva Systems, Inc.<\/a>\n<\/td>\n<td>Vault LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Venture_Development,_LLC\" title=\"Venture Development, LLC\" class=\"wiki-link\" data-key=\"bb09b542cdb980b9e079eb7ed44ad31d\">Venture Development, LLC<\/a>\n<\/td>\n<td>GoRev\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Health information system with LIMS\/LIS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Verisis_A.S.\" title=\"Verisis A.S.\" class=\"wiki-link\" data-key=\"bb56d9521846dc50b224bab78e2b78d0\">Verisis A.S.<\/a>\n<\/td>\n<td>CLIMS\n<\/td>\n<td>No\n<\/td>\n<td>Turkey\n<\/td>\n<td>\n<\/td>\n<td>Forensic LIMS\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/VertiQ_Software,_LLC\" title=\"VertiQ Software, LLC\" class=\"wiki-link\" data-key=\"4f2ae414b151aceccf4980c5d50e0cb2\">VertiQ Software, LLC<\/a>\n<\/td>\n<td>CME-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Forensic LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Vette_EDV-Beratung_%26_Entwicklung_GmbH\" title=\"Vette EDV-Beratung & Entwicklung GmbH\" class=\"wiki-link\" data-key=\"e965d5eba1258c1aeec41e9e9f7d6bc0\">Vette EDV-Beratung & Entwicklung GmbH<\/a>\n<\/td>\n<td>TransGraph\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>Quality management software with a LIMS module\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Waters_Corporation\" title=\"Waters Corporation\" class=\"wiki-link\" data-key=\"d17153eab93be07066660e3cff4b84c5\">Waters Corporation<\/a>\n<\/td>\n<td>NuGenesis 8\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Waters_Corporation#Pricing\" title=\"Waters Corporation\" class=\"wiki-link\" data-key=\"6cbe6118fd0313e8da7ef4a55da6679c\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Waters_Corporation#Demonstration_videos_and_other_media\" title=\"Waters Corporation\" class=\"wiki-link\" data-key=\"24c5384b687bab01cd218c1706f6b18a\">demonstration videos<\/a>\n<\/td>\n<td>NuGenesis 8 is a data management and workflow package<br \/>of applications, including NuGenesis Sample Management.<sup id=\"rdp-ebb-cite_ref-NG8PDF_27-0\" class=\"reference\"><a href=\"#cite_note-NG8PDF-27\">[27]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Wavefront_Software,_Inc.\" title=\"Wavefront Software, Inc.\" class=\"wiki-link\" data-key=\"2d02b77c16ac3bdc30c7e55ff7db4b03\">Wavefront Software, Inc.<\/a>\n<\/td>\n<td>Wavefront LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Wavefront_Software,_Inc.#Demonstration_videos_and_other_media\" title=\"Wavefront Software, Inc.\" class=\"wiki-link\" data-key=\"4cad97233976e6f6d303add8660ec7ee\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/WESTcom_Logiciels_et_Services_SARL\" title=\"WESTcom Logiciels et Services SARL\" class=\"wiki-link\" data-key=\"f80225d76ef83290ee82a464403c938b\">WESTcom Logiciels et Services SARL<\/a>\n<\/td>\n<td>ARES\n<\/td>\n<td>No\n<\/td>\n<td>France\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/WireWorks_West,_Inc.\" title=\"WireWorks West, Inc.\" class=\"wiki-link\" data-key=\"89f764ad282d49126cc24da9786f722a\">WireWorks West, Inc.<\/a>\n<\/td>\n<td>FermWorks\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Formerly operated as <a href=\"https:\/\/www.limswiki.org\/index.php\/Jova_Solutions_Inc.\" title=\"Jova Solutions Inc.\" class=\"wiki-link\" data-key=\"f1d582bbb9d0d4e025f6a596e2be8d37\">Jova Solutions Inc.<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Wixon_and_Cross,_LLC\" title=\"Wixon and Cross, LLC\" class=\"wiki-link\" data-key=\"9f9ddae3f43c6e73a3ed6b2883c6c0f4\">Wixon and Cross, LLC<\/a>\n<\/td>\n<td>LIMFinite\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Wolfe_Information_Systems,_Inc.\" title=\"Wolfe Information Systems, Inc.\" class=\"wiki-link\" data-key=\"25980c0e09af7861cf87b6a0a5ba08e1\">Wolfe Information Systems, Inc.<\/a>\n<\/td>\n<td>Wolfe LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Wolfe_Information_Systems,_Inc.#Pricing\" title=\"Wolfe Information Systems, Inc.\" class=\"wiki-link\" data-key=\"3eac29cd3e31b022b6f6e7ffb0570e42\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Xybion_Corporation\" title=\"Xybion Corporation\" class=\"wiki-link\" data-key=\"ee87743428afb8c831b21e711e9e12e2\">Xybion Corporation<\/a>\n<\/td>\n<td>Labwise XD, Pristima XD\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Xybion_Corporation#Pricing\" title=\"Xybion Corporation\" class=\"wiki-link\" data-key=\"72acddce9a5e73ee70e01d6157804175\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Xybion_Corporation#Demonstration_videos_and_other_media\" title=\"Xybion Corporation\" class=\"wiki-link\" data-key=\"44fcaf25c1815476c3807f12cb8f302b\">demonstration videos<\/a>\n<\/td>\n<td>Pre-clinical LIMS solutions\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Yokogawa_Electric_Corporation\" title=\"Yokogawa Electric Corporation\" class=\"wiki-link\" data-key=\"bf63d081730579793d5bb288c5c05270\">Yokogawa Electric Corporation<\/a>\n<\/td>\n<td>OpreX, CIMVisionLIMS\n<\/td>\n<td>No\n<\/td>\n<td>Japan\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Yro_Systems_Pvt._Ltd.\" title=\"Yro Systems Pvt. Ltd.\" class=\"wiki-link\" data-key=\"736b956c9dab664ca911fea7ad3a47c3\">Yro Systems Pvt. Ltd.<\/a>\n<\/td>\n<td>MocDoc LIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Yullin_Technologies_Co.,_Ltd.\" title=\"Yullin Technologies Co., Ltd.\" class=\"wiki-link\" data-key=\"60cbee5540617d1233b538a008cf9ef7\">Yullin Technologies Co., Ltd.<\/a>\n<\/td>\n<td>LabMate Enterprise\n<\/td>\n<td>No\n<\/td>\n<td>South Korea\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/div>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-DSDatamine19-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DSDatamine19_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.dataminesoftware.com\/2019\/08\/27\/datamine-acquires-ims\/\" target=\"_blank\">\"Datamine Acquires Intelligent Mining Solutions (IMS)\"<\/a>. Datamine Software Ltd. 27 August 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.dataminesoftware.com\/2019\/08\/27\/datamine-acquires-ims\/\" target=\"_blank\">http:\/\/www.dataminesoftware.com\/2019\/08\/27\/datamine-acquires-ims\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 28 September 2019<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Datamine+Acquires+Intelligent+Mining+Solutions+%28IMS%29&rft.atitle=&rft.date=27+August+2019&rft.pub=Datamine+Software+Ltd&rft_id=http%3A%2F%2Fwww.dataminesoftware.com%2F2019%2F08%2F27%2Fdatamine-acquires-ims%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AgilentiLabAcqComp-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AgilentiLabAcqComp_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.agilent.com\/about\/newsroom\/presrel\/2016\/01aug-gp16015.html\" target=\"_blank\">\"Agilent Technologies Completes Asset Acquisition of iLab Solutions, a Leader in Cloud-Based Laboratory Management Software\"<\/a>. 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(2 May 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/actu.epfl.ch\/news\/us-group-agilent-enters-epfl-innovation-park-by-ac\/\" target=\"_blank\">\"US group Agilent enters EPFL Innovation Park by acquiring Genohm\"<\/a>. <i>EPFL News<\/i>. \u00c9cole polytechnique f\u00e9d\u00e9rale de Lausanne<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/actu.epfl.ch\/news\/us-group-agilent-enters-epfl-innovation-park-by-ac\/\" target=\"_blank\">https:\/\/actu.epfl.ch\/news\/us-group-agilent-enters-epfl-innovation-park-by-ac\/<\/a><\/span><span class=\"reference-accessdate\">. 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S.C Cylex Tehnologia Informatiei International S.N.C<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web2.cylex.de\/firma-home\/rhapsody-software-solutions-gmbh-1447434.html\" target=\"_blank\">https:\/\/web2.cylex.de\/firma-home\/rhapsody-software-solutions-gmbh-1447434.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 15 January 2019<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=RHAPSODY+Software+Solutions+GmbH%2C+Ibbenb%C3%BCren&rft.atitle=Cylex&rft.pub=S.C+Cylex+Tehnologia+Informatiei+International+S.N.C&rft_id=https%3A%2F%2Fweb2.cylex.de%2Ffirma-home%2Frhapsody-software-solutions-gmbh-1447434.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-OHRSoftwaresysteme-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-OHRSoftwaresysteme_22-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.online-handelsregister.de\/handelsregisterauszug\/nw\/Steinfurt\/S\/Softwaresysteme+Keeve+GmbH\/1798127\" target=\"_blank\">\"Softwaresysteme Keeve GmbH\"<\/a>. <i>online-handelregister.de<\/i>. Registeranzeiger GmbH<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.online-handelsregister.de\/handelsregisterauszug\/nw\/Steinfurt\/S\/Softwaresysteme+Keeve+GmbH\/1798127\" target=\"_blank\">https:\/\/www.online-handelsregister.de\/handelsregisterauszug\/nw\/Steinfurt\/S\/Softwaresysteme+Keeve+GmbH\/1798127<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 15 January 2019<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Softwaresysteme+Keeve+GmbH&rft.atitle=online-handelregister.de&rft.pub=Registeranzeiger+GmbH&rft_id=https%3A%2F%2Fwww.online-handelsregister.de%2Fhandelsregisterauszug%2Fnw%2FSteinfurt%2FS%2FSoftwaresysteme%2BKeeve%2BGmbH%2F1798127&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-23\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-23\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.labvantage.com\/newsroom\/index.php\/2011\/04\/labvantage-acquires-long-time-partner-software-point\/\" target=\"_blank\">\"LABVANTAGE Acquires Long-Time Partner Software Point\"<\/a>. LABVANTAGE Solutions, Inc. 5 April 2011<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.labvantage.com\/newsroom\/index.php\/2011\/04\/labvantage-acquires-long-time-partner-software-point\/\" target=\"_blank\">http:\/\/www.labvantage.com\/newsroom\/index.php\/2011\/04\/labvantage-acquires-long-time-partner-software-point\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 2 January 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=LABVANTAGE+Acquires+Long-Time+Partner+Software+Point&rft.atitle=&rft.date=5+April+2011&rft.pub=LABVANTAGE+Solutions%2C+Inc&rft_id=http%3A%2F%2Fwww.labvantage.com%2Fnewsroom%2Findex.php%2F2011%2F04%2Flabvantage-acquires-long-time-partner-software-point%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-24\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-24\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.softwarepoint.com\/news.html\" target=\"_blank\">\"Software Point - News\"<\/a>. Software Point Oy. 21 December 2012<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.softwarepoint.com\/news.html\" target=\"_blank\">http:\/\/www.softwarepoint.com\/news.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 10 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Point+-+News&rft.atitle=&rft.date=21+December+2012&rft.pub=Software+Point+Oy&rft_id=http%3A%2F%2Fwww.softwarepoint.com%2Fnews.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-OSArch1-25\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-OSArch1_25-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20150815162117\/https:\/\/www.objectsolutions.eu\/\" target=\"_blank\">\"Object Solutions\"<\/a>. SpecPage plc. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.objectsolutions.eu\/\" target=\"_blank\">the original<\/a> on 15 August 2015<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20150815162117\/https:\/\/www.objectsolutions.eu\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20150815162117\/https:\/\/www.objectsolutions.eu\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 July 2016<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Object+Solutions&rft.atitle=&rft.pub=SpecPage+plc&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20150815162117%2Fhttps%3A%2F%2Fwww.objectsolutions.eu%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SPArch1-26\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SPArch1_26-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"nofollow\" class=\"external text\" href=\"#002845730ff39021e\">\"Press\"<\/a>. SpecPage plc. Archived from <a rel=\"nofollow\" class=\"external text\" href=\"#002845730ff39021e\">the original<\/a> on 10 July 2016<span class=\"printonly\">. <a rel=\"nofollow\" class=\"external free\" href=\"#002845730ff39021e\">https:\/\/web.archive.org\/web\/20160710173713\/https:\/\/www.specpage.com\/about-us\/press\/#002845730ff39021e<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 July 2016<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Press&rft.atitle=&rft.pub=SpecPage+plc&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20160710173713%2Fhttps%3A%2F%2Fwww.specpage.com%2Fabout-us%2Fpress%2F%23002845730ff39021e&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NG8PDF-27\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NG8PDF_27-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.waters.com\/webassets\/cms\/library\/docs\/720003597en.pdf\" target=\"_blank\">\"NuGenesis 8 Featuring LE Technologies\"<\/a> (PDF). Waters Corporation<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.waters.com\/webassets\/cms\/library\/docs\/720003597en.pdf\" target=\"_blank\">http:\/\/www.waters.com\/webassets\/cms\/library\/docs\/720003597en.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 20 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=NuGenesis+8+Featuring+LE+Technologies&rft.atitle=&rft.pub=Waters+Corporation&rft_id=http%3A%2F%2Fwww.waters.com%2Fwebassets%2Fcms%2Flibrary%2Fdocs%2F720003597en.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230516215748\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.358 seconds\nReal time usage: 0.380 seconds\nPreprocessor visited node count: 18028\/1000000\nPost\u2010expand include size: 221019\/2097152 bytes\nTemplate argument size: 55209\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 42751\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 256.630 1 -total\n 90.80% 233.024 1 Template:Reflist\n 80.37% 206.251 27 Template:Cite_web\n 74.11% 190.184 27 Template:Citation\/core\n 15.77% 40.464 19 Template:Date\n 9.16% 23.511 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\n 7.65% 19.623 1 Template:All_active_LIMS_vendors\n 5.35% 13.719 44 Template:Citation\/make_link\n 1.27% 3.260 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14182-0!canonical and timestamp 20230516215747 and revision id 52004. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","d1c053b2048cf912b5b8f8e81bfa051d_images":[],"d1c053b2048cf912b5b8f8e81bfa051d_timestamp":1684275143,"5a3c4f3a39640cce57b0d27985a4ca7a_type":"article","5a3c4f3a39640cce57b0d27985a4ca7a_title":"3.4 How a user requirements specification fits into the entire process (LIMSpec)","5a3c4f3a39640cce57b0d27985a4ca7a_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)","5a3c4f3a39640cce57b0d27985a4ca7a_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Choosing laboratory informatics software for your manufacturing lab\/How a user requirements specification fits into the entire process (LIMSpec)From LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n 3.4 How a user requirements specification fits into the entire process (LIMSpec) \nMerriam-Webster defines a \"specification\" as \"a detailed precise presentation of something or of a plan or proposal for something.\"[1] In other words, an existing or theoretical product, concept, or idea is presented in detail for a particular audience. In a broad sense, detailing the specifics about a project, concept, or idea to others is just common sense. This applies just as well to the world of software development, where a software requirements specification is essential for preventing the second most commonly cited reason for project failure: poor requirements management.[2] \nIn fact, the ISO\/IEC\/IEEE 29148:2018 standard (a conglomeration of what was formerly IEEE 830 and other standards) is in place to help specify \"the required processes implemented in the engineering activities that result in requirements for systems and software products\" and provide guidelines for how to apply those requirements.[3] The standard describes the characteristics that make up quality software requirement development, including aspects such as[4]:\n\ncorrectly describing system behavior;\neffectively removing ambiguity from the language used;\ncompletely covering the system behavior and features;\naccurately prioritizing and ranking the requirements; and\nunequivocally ensuring the requirements are testable, modifiable, and traceable.\nA requirement typically comes in the form of a statement that begins with \"the system\/user\/vendor shall\/should ...\" and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level) or specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered. An example of a functional software requirement could be \"the user shall be able to query either all of the initial set of databases or select a subset from it.\" This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state \"the system's query tool shall conform to the ABC 123-2014 standard.\" The statement describes a constraint placed upon the system's query functionality. \nThis is where a requirements specification shines, not only for the software developer but also for those acquiring the software. A set of development requirements, compiled in the form of a software requirements specification, can serve to strengthen the software development process. For those acquiring the software, a set of user requirements, compiled in the form of a URS, can be used for the selection and acquisition of software or a service.[5][6] In the case of the URS, the acquiring business can approach this several ways. The simple way would be to essentially take the vendor at the word in regards to what they say their system can and can't do, agreeing formally to their description and taking responsibility that it will cover all the applicable regulations required by your business. However, this method isn't comprehensive and leaves the business open to not being able to fully meet its goals.[6]\nThe other method has the URS be specific to your business' needs. The process is more work but leaves less to chance.[6] Developing your own URS isn't always straightforward. Often times, the developed document turns into a mix of \"wishlist\" requirements from potential and active clients, as well as regulation-mandated requirements. The wishlist items aren't necessarily ignored by developers, but the URS should in fact clearly prioritize requirements as \"nice to have\" or \"essential to system operation,\" or something in between.[7][8][9] Whatever the URS looks like in the end, it's ultimately up to the vendor to be able to demonstrate how the software does and does not meet its requirements.\nIn the latter half of this guide, you'll be given an opportunity to see an example of a URS for the manufacturing industry in the form of LIMSpec, an evolving set of software requirements specifications for laboratory informatics systems. Built from requirements found in ASTM E1578-18 Standard Guide for Laboratory Informatics, as well as dozens of other standards and regulations, we will use LIMSpec to demonstrate how a URS can be put to use, while also showing you how an informatics system can help you laboratory better meet regulatory requirements.\n\nReferences \n\n\n\u2191 \"specification\". Merriam-Webster. Merriam-Webster, Inc. https:\/\/www.merriam-webster.com\/dictionary\/specification . Retrieved 05 May 2023 .   \n \n\n\u2191 Bieg, D.P. (August 2014). \"Introduction\" (PDF). Requirements Management: A Core Competency for Project and Program Success. Project Management Institute. p. 3. https:\/\/www.pmi.org\/-\/media\/pmi\/documents\/public\/pdf\/learning\/thought-leadership\/pulse\/requirements-management.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 \"ISO\/IEC\/IEEE 29148:2018\". International Organization for Standardization. November 2018. https:\/\/www.iso.org\/standard\/72089.html . Retrieved 05 May 2023 .   \n \n\n\u2191 Seibert, P. (28 July 2011). \"How do you write software requirements? What are software requirements? What is a software requirement?\". HubTechInsider. https:\/\/hubtechinsider.wordpress.com\/2011\/07\/28\/how-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Memon, A. (Spring 2010). \"Software Requirements: Descriptions and specifications of a system\" (PDF). University of Maryland. https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 6.0 6.1 6.2 Schmitt, S. (2018). \"User Requirements Specifications\u2013How Difficult Can It Be?\". Pharmaceutical Technology 42 (11): 58. https:\/\/www.pharmtech.com\/view\/user-requirements-specifications-how-difficult-can-it-be-0 . Retrieved 05 May 2023 .   \n \n\n\u2191 Aasem, M.; Ramzan, M.; Jaffar, A. (2010). \"Analysis and optimization of software requirements prioritization techniques\". Proceedings from the 2010 International Conference on Information and Emerging Technologies: 1\u20136. doi:10.1109\/ICIET.2010.5625687.   \n \n\n\u2191 Hirsch, J. (22 November 2013). \"10 Steps To Successful Requirements Gathering\". Phase2 Technology, LLC. https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering . Retrieved 05 May 2023 .   \n \n\n\u2191 Burris, E. (2007). \"Requirements Specification\". CS451R, University of Missouri\u2013Kansas City. University of Missouri\u2013Kansas City. Archived from the original on 25 September 2019. https:\/\/web.archive.org\/web\/20190925003040\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/ . Retrieved 05 May 2023 .   \n \n\n\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 3. Choosing laboratory informatics software for your manufacturing lab\nTitle: LIMS Selection Guide for Manufacturing Quality Control\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: May 2023\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 21:57.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 3 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","5a3c4f3a39640cce57b0d27985a4ca7a_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Choosing_laboratory_informatics_software_for_your_manufacturing_lab_How_a_user_requirements_specification_fits_into_the_entire_process_LIMSpec rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Choosing_laboratory_informatics_software_for_your_manufacturing_lab_How_a_user_requirements_specification_fits_into_the_entire_process_LIMSpec skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Choosing laboratory informatics software for your manufacturing lab\/How a user requirements specification fits into the entire process (LIMSpec)<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<h3><span id=\"rdp-ebb-3.4_How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\"><\/span><span class=\"mw-headline\" id=\"3.4_How_a_user_requirements_specification_fits_into_the_entire_process_.28LIMSpec.29\">3.4 How a user requirements specification fits into the entire process (LIMSpec)<\/span><\/h3>\n<p>Merriam-Webster defines a \"specification\" as \"a detailed precise presentation of something or of a plan or proposal for something.\"<sup id=\"rdp-ebb-cite_ref-MWSpec_1-0\" class=\"reference\"><a href=\"#cite_note-MWSpec-1\">[1]<\/a><\/sup> In other words, an existing or theoretical product, concept, or idea is presented in detail for a particular audience. In a broad sense, detailing the specifics about a project, concept, or idea to others is just common sense. This applies just as well to the world of software development, where a software requirements specification is essential for preventing the second most commonly cited reason for project failure: poor requirements management.<sup id=\"rdp-ebb-cite_ref-BiegRequire14_2-0\" class=\"reference\"><a href=\"#cite_note-BiegRequire14-2\">[2]<\/a><\/sup> \n<\/p><p>In fact, the ISO\/IEC\/IEEE 29148:2018 standard (a conglomeration of what was formerly IEEE 830 and other standards) is in place to help specify \"the required processes implemented in the engineering activities that result in requirements for systems and software products\" and provide guidelines for how to apply those requirements.<sup id=\"rdp-ebb-cite_ref-ISO29148_3-0\" class=\"reference\"><a href=\"#cite_note-ISO29148-3\">[3]<\/a><\/sup> The standard describes the characteristics that make up quality software requirement development, including aspects such as<sup id=\"rdp-ebb-cite_ref-SeibertHowDoYou11_4-0\" class=\"reference\"><a href=\"#cite_note-SeibertHowDoYou11-4\">[4]<\/a><\/sup>:\n<\/p>\n<ul><li>correctly describing system behavior;<\/li>\n<li>effectively removing ambiguity from the language used;<\/li>\n<li>completely covering the system behavior and features;<\/li>\n<li>accurately prioritizing and ranking the requirements; and<\/li>\n<li>unequivocally ensuring the requirements are testable, modifiable, and traceable.<\/li><\/ul>\n<p>A requirement typically comes in the form of a statement that begins with \"the system\/user\/vendor shall\/should ...\" and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level) or specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered. An example of a functional software requirement could be \"the user shall be able to query either all of the initial set of databases or select a subset from it.\" This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state \"the system's query tool shall conform to the ABC 123-2014 standard.\" The statement describes a constraint placed upon the system's query functionality. \n<\/p><p>This is where a requirements specification shines, not only for the software developer but also for those acquiring the software. A set of development requirements, compiled in the form of a software requirements specification, can serve to strengthen the software development process. For those acquiring the software, a set of user requirements, compiled in the form of a URS, can be used for the selection and acquisition of software or a service.<sup id=\"rdp-ebb-cite_ref-MemonSoftware10_5-0\" class=\"reference\"><a href=\"#cite_note-MemonSoftware10-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SchmittUser18_6-0\" class=\"reference\"><a href=\"#cite_note-SchmittUser18-6\">[6]<\/a><\/sup> In the case of the URS, the acquiring business can approach this several ways. The simple way would be to essentially take the vendor at the word in regards to what they say their system can and can't do, agreeing formally to their description and taking responsibility that it will cover all the applicable regulations required by your business. However, this method isn't comprehensive and leaves the business open to not being able to fully meet its goals.<sup id=\"rdp-ebb-cite_ref-SchmittUser18_6-1\" class=\"reference\"><a href=\"#cite_note-SchmittUser18-6\">[6]<\/a><\/sup>\n<\/p><p>The other method has the URS be specific to your business' needs. The process is more work but leaves less to chance.<sup id=\"rdp-ebb-cite_ref-SchmittUser18_6-2\" class=\"reference\"><a href=\"#cite_note-SchmittUser18-6\">[6]<\/a><\/sup> Developing your own URS isn't always straightforward. Often times, the developed document turns into a mix of \"wishlist\" requirements from potential and active clients, as well as regulation-mandated requirements. The wishlist items aren't necessarily ignored by developers, but the URS should in fact clearly prioritize requirements as \"nice to have\" or \"essential to system operation,\" or something in between.<sup id=\"rdp-ebb-cite_ref-AasemAnalysis10_7-0\" class=\"reference\"><a href=\"#cite_note-AasemAnalysis10-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Hirsch10Steps13_8-0\" class=\"reference\"><a href=\"#cite_note-Hirsch10Steps13-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BurrissSoftware07_9-0\" class=\"reference\"><a href=\"#cite_note-BurrissSoftware07-9\">[9]<\/a><\/sup> Whatever the URS looks like in the end, it's ultimately up to the vendor to be able to demonstrate how the software does and does not meet its requirements.\n<\/p><p>In the latter half of this guide, you'll be given an opportunity to see an example of a URS for the manufacturing industry in the form of LIMSpec, an evolving set of software requirements specifications for laboratory informatics systems. Built from requirements found in <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> <i>Standard Guide for Laboratory Informatics<\/i>, as well as dozens of other standards and regulations, we will use LIMSpec to demonstrate how a URS can be put to use, while also showing you how an informatics system can help you laboratory better meet regulatory requirements.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-MWSpec-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MWSpec_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.merriam-webster.com\/dictionary\/specification\" target=\"_blank\">\"specification\"<\/a>. <i>Merriam-Webster<\/i>. Merriam-Webster, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.merriam-webster.com\/dictionary\/specification\" target=\"_blank\">https:\/\/www.merriam-webster.com\/dictionary\/specification<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=specification&rft.atitle=Merriam-Webster&rft.pub=Merriam-Webster%2C+Inc&rft_id=https%3A%2F%2Fwww.merriam-webster.com%2Fdictionary%2Fspecification&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BiegRequire14-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BiegRequire14_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Bieg, D.P. (August 2014). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pmi.org\/-\/media\/pmi\/documents\/public\/pdf\/learning\/thought-leadership\/pulse\/requirements-management.pdf\" target=\"_blank\">\"Introduction\"<\/a> (PDF). <i>Requirements Management: A Core Competency for Project and Program Success<\/i>. Project Management Institute. p. 3<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.pmi.org\/-\/media\/pmi\/documents\/public\/pdf\/learning\/thought-leadership\/pulse\/requirements-management.pdf\" target=\"_blank\">https:\/\/www.pmi.org\/-\/media\/pmi\/documents\/public\/pdf\/learning\/thought-leadership\/pulse\/requirements-management.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Introduction&rft.atitle=Requirements+Management%3A+A+Core+Competency+for+Project+and+Program+Success&rft.aulast=Bieg%2C+D.P.&rft.au=Bieg%2C+D.P.&rft.date=August+2014&rft.pages=p.+3&rft.pub=Project+Management+Institute&rft_id=https%3A%2F%2Fwww.pmi.org%2F-%2Fmedia%2Fpmi%2Fdocuments%2Fpublic%2Fpdf%2Flearning%2Fthought-leadership%2Fpulse%2Frequirements-management.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ISO29148-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ISO29148_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/72089.html\" target=\"_blank\">\"ISO\/IEC\/IEEE 29148:2018\"<\/a>. International Organization for Standardization. November 2018<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.iso.org\/standard\/72089.html\" target=\"_blank\">https:\/\/www.iso.org\/standard\/72089.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ISO%2FIEC%2FIEEE+29148%3A2018&rft.atitle=&rft.date=November+2018&rft.pub=International+Organization+for+Standardization&rft_id=https%3A%2F%2Fwww.iso.org%2Fstandard%2F72089.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SeibertHowDoYou11-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SeibertHowDoYou11_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Seibert, P. (28 July 2011). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/hubtechinsider.wordpress.com\/2011\/07\/28\/how-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement\/\" target=\"_blank\">\"How do you write software requirements? What are software requirements? What is a software requirement?\"<\/a>. <i>HubTechInsider<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/hubtechinsider.wordpress.com\/2011\/07\/28\/how-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement\/\" target=\"_blank\">https:\/\/hubtechinsider.wordpress.com\/2011\/07\/28\/how-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+do+you+write+software+requirements%3F+What+are+software+requirements%3F+What+is+a+software+requirement%3F&rft.atitle=HubTechInsider&rft.aulast=Seibert%2C+P.&rft.au=Seibert%2C+P.&rft.date=28+July+2011&rft_id=https%3A%2F%2Fhubtechinsider.wordpress.com%2F2011%2F07%2F28%2Fhow-do-you-write-software-requirements-what-are-software-requirements-what-is-a-software-requirement%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MemonSoftware10-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MemonSoftware10_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Memon, A. (Spring 2010). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf\" target=\"_blank\">\"Software Requirements: Descriptions and specifications of a system\"<\/a> (PDF). University of Maryland<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf\" target=\"_blank\">https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Requirements%3A+Descriptions+and+specifications+of+a+system&rft.atitle=&rft.aulast=Memon%2C+A.&rft.au=Memon%2C+A.&rft.date=Spring+2010&rft.pub=University+of+Maryland&rft_id=https%3A%2F%2Fwww.cs.umd.edu%2F%7Eatif%2FTeaching%2FSpring2010%2FSlides%2F3.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SchmittUser18-6\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-SchmittUser18_6-0\">6.0<\/a><\/sup> <sup><a href=\"#cite_ref-SchmittUser18_6-1\">6.1<\/a><\/sup> <sup><a href=\"#cite_ref-SchmittUser18_6-2\">6.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Schmitt, S. (2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pharmtech.com\/view\/user-requirements-specifications-how-difficult-can-it-be-0\" target=\"_blank\">\"User Requirements Specifications\u2013How Difficult Can It Be?\"<\/a>. <i>Pharmaceutical Technology<\/i> <b>42<\/b> (11): 58<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.pharmtech.com\/view\/user-requirements-specifications-how-difficult-can-it-be-0\" target=\"_blank\">https:\/\/www.pharmtech.com\/view\/user-requirements-specifications-how-difficult-can-it-be-0<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=User+Requirements+Specifications%E2%80%93How+Difficult+Can+It+Be%3F&rft.jtitle=Pharmaceutical+Technology&rft.aulast=Schmitt%2C+S.&rft.au=Schmitt%2C+S.&rft.date=2018&rft.volume=42&rft.issue=11&rft.pages=58&rft_id=https%3A%2F%2Fwww.pharmtech.com%2Fview%2Fuser-requirements-specifications-how-difficult-can-it-be-0&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AasemAnalysis10-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AasemAnalysis10_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Aasem, M.; Ramzan, M.; Jaffar, A. (2010). \"Analysis and optimization of software requirements prioritization techniques\". <i>Proceedings from the 2010 International Conference on Information and Emerging Technologies<\/i>: 1\u20136. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1109%2FICIET.2010.5625687\" target=\"_blank\">10.1109\/ICIET.2010.5625687<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Analysis+and+optimization+of+software+requirements+prioritization+techniques&rft.jtitle=Proceedings+from+the+2010+International+Conference+on+Information+and+Emerging+Technologies&rft.aulast=Aasem%2C+M.%3B+Ramzan%2C+M.%3B+Jaffar%2C+A.&rft.au=Aasem%2C+M.%3B+Ramzan%2C+M.%3B+Jaffar%2C+A.&rft.date=2010&rft.pages=1%E2%80%936&rft_id=info:doi\/10.1109%2FICIET.2010.5625687&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Hirsch10Steps13-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Hirsch10Steps13_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Hirsch, J. (22 November 2013). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering\" target=\"_blank\">\"10 Steps To Successful Requirements Gathering\"<\/a>. Phase2 Technology, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering\" target=\"_blank\">https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering<\/a><\/span><span class=\"reference-accessdate\">. 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(2007). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20190925003040\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">\"Requirements Specification\"<\/a>. <i>CS451R, University of Missouri\u2013Kansas City<\/i>. University of Missouri\u2013Kansas City. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">the original<\/a> on 25 September 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20190925003040\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20190925003040\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Requirements+Specification&rft.atitle=CS451R%2C+University+of+Missouri%E2%80%93Kansas+City&rft.aulast=Burris%2C+E.&rft.au=Burris%2C+E.&rft.date=2007&rft.pub=University+of+Missouri%E2%80%93Kansas+City&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20190925003040%2Fhttp%3A%2F%2Fsce2.umkc.edu%2FBIT%2Fburrise%2Fpl%2Frequirements%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<p><br \/>\n<\/p>\n<div align=\"center\">-----Go to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Resources for selecting and implementing informatics solutions\/LIMS vendors\" class=\"wiki-link\" data-key=\"d1c053b2048cf912b5b8f8e81bfa051d\">the next chapter<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: 3. Choosing laboratory informatics software for your manufacturing lab\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for Manufacturing Quality Control<\/i>\n<\/p><p><b>Edition<\/b>: First Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: May 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230516215919\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.131 seconds\nReal time usage: 0.150 seconds\nPreprocessor visited node count: 6294\/1000000\nPost\u2010expand include size: 51888\/2097152 bytes\nTemplate argument size: 17554\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 15888\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 137.176 1 -total\n 91.69% 125.776 1 Template:Reflist\n 66.49% 91.211 9 Template:Citation\/core\n 54.75% 75.097 7 Template:Cite_web\n 24.42% 33.500 2 Template:Cite_journal\n 11.90% 16.321 6 Template:Date\n 9.93% 13.619 1 Template:Citation\/identifier\n 8.20% 11.248 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\n 4.96% 6.810 14 Template:Citation\/make_link\n 2.93% 4.021 2 Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14181-0!canonical and timestamp 20230516215919 and revision id 52003. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","5a3c4f3a39640cce57b0d27985a4ca7a_images":[],"5a3c4f3a39640cce57b0d27985a4ca7a_timestamp":1684275143,"951ce542e526420f000495fb950c810e_type":"article","951ce542e526420f000495fb950c810e_title":"3.3 MSW, updates, and other contracted services","951ce542e526420f000495fb950c810e_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/MSW,_updates,_and_other_contracted_services","951ce542e526420f000495fb950c810e_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Choosing laboratory informatics software for your manufacturing lab\/MSW, updates, and other contracted servicesFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n 3.3 MSW, updates, and other contracted services \nThe MSW offered with the vendor's solution is almost as important as the solution itself. The laboratory informatics solution you acquire is more than than the software you operate: it's mission-critical and deserves having a reliable and responsive team with the necessary resources to ensure it remains operational. Downtime can negatively affect both immediate customer satisfaction and your reputation. As such, it's imperative you ask the vendor about the details of its MSW, making sure you understand what is and isn't covered, as well as how much it will cost. Cost-wise, industry norms are anywhere from 15% to 25% of either the license fee or total contract, levied annually to provide this coverage.[1] Alternatively, it may simply be included with your subscription. The MSW will include a specified number of support and maintenance hours or guarantees. The actual warranty should be unlimited for as long as the MSW or subscription is kept current.\nMaintenance includes any and all work necessary to keep your system working as designed. It should include updates, patches, or fixes, and most if not all upgrades. (Note, however, a major upgrade to a totally new edition may not be covered, but it may come at a negotiable, significantly lower cost.[2]) The support aspect of MSW generally consists of a specified number of hours dedicated more to helping you with the operation of the system rather than \"fixing\" anything. Support includes guidance on training, password or login support, and more. Finally, with any professional application you also expect to have a warranty. The warranty should cover anything that doesn't work that otherwise should for the designated period of time.[2] That includes any standard features and functions, as well as any additional ones that were delivered and signed off on, and any other work performed by the vendor or its representatives. However, a typical warranty does not cover anything that was working fine, but upon being manipulated in a way beyond normal operation the functionality ceased. In these cases, you'll probably have to pay to get it fixed.\nBeyond the MSW, additional updates and services related to the system may also be required. No matter how well it is pre-configured, any professional laboratory informatics solution will require some amount of standard setup to reflect your particular lab. This includes adding lab branding and demographics for reports and certificates; entering users, their roles, and access permissions; adding and\/or modifying tests and workflows; renaming fields; adding or hiding fields; setting up a web portal; and implementing interfaces. Equally indispensable is proper training for both users and administrators. And of course you may later find that you would like additional features or functions. These and other services may prove particularly useful to the laboratory with little in the way of IT and systems expertise. As such, the vendor may provide one or more of the following as a billable service for the laboratory:\n\ninitial implementation meeting (e.g., initial planning, identify delta, set schedule)\nproject management\nrequirements gathering and documentation\ninitial setup\nuser and administrator training\nconfiguration and customization\ninterface development and implementation\ncustom screen and field development\ncustom functionality development\ncustom reports and labels\ncustom triggers and alerts\nvalidation or acceptance testing (to a third-party standard or certification, or to agreed manufacturer specs)\nReferences \n\n\n\u2191 Scavo, F. (8 February 2005). \"High Software Maintenance Fees and What to Do About Them\". Computer Economics. Archived from the original on 15 November 2022. https:\/\/web.archive.org\/web\/20221115005436\/https:\/\/www.computereconomics.com\/article.cfm?id=1033 . Retrieved 05 May 2023 .   \n \n\n\u2191 2.0 2.1 Gordon-Byrne, G. (2014). \"Maintenance in the Digital World\". IT Performance Improvement. Taylor & Francis, LLC. Archived from the original on 05 May 2021. https:\/\/web.archive.org\/web\/20210505220938\/http:\/\/www.ittoday.info\/ITPerformanceImprovement\/Articles\/2014-08GordonByrne2.html . Retrieved 05 May 2023 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/MSW,_updates,_and_other_contracted_services\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/MSW,_updates,_and_other_contracted_services<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 21:55.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","951ce542e526420f000495fb950c810e_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Choosing_laboratory_informatics_software_for_your_manufacturing_lab_MSW_updates_and_other_contracted_services rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Choosing_laboratory_informatics_software_for_your_manufacturing_lab_MSW_updates_and_other_contracted_services skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Choosing laboratory informatics software for your manufacturing lab\/MSW, updates, and other contracted services<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<h3><span id=\"rdp-ebb-3.3_MSW,_updates,_and_other_contracted_services\"><\/span><span class=\"mw-headline\" id=\"3.3_MSW.2C_updates.2C_and_other_contracted_services\">3.3 MSW, updates, and other contracted services<\/span><\/h3>\n<div class=\"floatleft\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Warranty_(267038)_-_The_Noun_Project.svg\" class=\"image wiki-link\" data-key=\"3f1b83843895fcf788d1fe871ab97a0e\"><img alt=\"Warranty (267038) - The Noun Project.svg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/a\/a0\/Warranty_%28267038%29_-_The_Noun_Project.svg\/200px-Warranty_%28267038%29_-_The_Noun_Project.svg.png\" decoding=\"async\" width=\"200\" height=\"200\" \/><\/a><\/div><p>The MSW offered with the vendor's solution is almost as important as the solution itself. The laboratory informatics solution you acquire is more than than the software you operate: it's mission-critical and deserves having a reliable and responsive team with the necessary resources to ensure it remains operational. Downtime can negatively affect both immediate customer satisfaction and your reputation. As such, it's imperative you ask the vendor about the details of its MSW, making sure you understand what is and isn't covered, as well as how much it will cost. Cost-wise, industry norms are anywhere from 15% to 25% of either the license fee or total contract, levied annually to provide this coverage.<sup id=\"rdp-ebb-cite_ref-ScavoHigh05_1-0\" class=\"reference\"><a href=\"#cite_note-ScavoHigh05-1\">[1]<\/a><\/sup> Alternatively, it may simply be included with your subscription. The MSW will include a specified number of support and maintenance hours or guarantees. The actual warranty should be unlimited for as long as the MSW or subscription is kept current.\n<\/p><p>Maintenance includes any and all work necessary to keep your system working as designed. It should include updates, patches, or fixes, and most if not all upgrades. (Note, however, a major upgrade to a totally new edition may not be covered, but it may come at a negotiable, significantly lower cost.<sup id=\"rdp-ebb-cite_ref-Gordon-ByrneMaint14_2-0\" class=\"reference\"><a href=\"#cite_note-Gordon-ByrneMaint14-2\">[2]<\/a><\/sup>) The support aspect of MSW generally consists of a specified number of hours dedicated more to helping you with the operation of the system rather than \"fixing\" anything. Support includes guidance on training, password or login support, and more. Finally, with any professional application you also expect to have a warranty. The warranty should cover anything that doesn't work that otherwise should for the designated period of time.<sup id=\"rdp-ebb-cite_ref-Gordon-ByrneMaint14_2-1\" class=\"reference\"><a href=\"#cite_note-Gordon-ByrneMaint14-2\">[2]<\/a><\/sup> That includes any standard features and functions, as well as any additional ones that were delivered and signed off on, and any other work performed by the vendor or its representatives. However, a typical warranty does not cover anything that was working fine, but upon being manipulated in a way beyond normal operation the functionality ceased. In these cases, you'll probably have to pay to get it fixed.\n<\/p><p>Beyond the MSW, additional updates and services related to the system may also be required. No matter how well it is pre-configured, any professional laboratory informatics solution will require some amount of standard setup to reflect your particular lab. This includes adding lab branding and demographics for reports and certificates; entering users, their roles, and access permissions; adding and\/or modifying tests and workflows; renaming fields; adding or hiding fields; setting up a web portal; and implementing interfaces. Equally indispensable is proper training for both users and administrators. And of course you may later find that you would like additional features or functions. These and other services may prove particularly useful to the laboratory with little in the way of IT and systems expertise. As such, the vendor may provide one or more of the following as a billable service for the laboratory:\n<\/p>\n<ul><li>initial implementation meeting (e.g., initial planning, identify delta, set schedule)<\/li>\n<li>project management<\/li>\n<li>requirements gathering and documentation<\/li>\n<li>initial setup<\/li>\n<li>user and administrator training<\/li>\n<li>configuration and customization<\/li>\n<li>interface development and implementation<\/li>\n<li>custom screen and field development<\/li>\n<li>custom functionality development<\/li>\n<li>custom reports and labels<\/li>\n<li>custom triggers and alerts<\/li>\n<li>validation or acceptance testing (to a third-party standard or certification, or to agreed manufacturer specs)<\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-ScavoHigh05-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ScavoHigh05_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Scavo, F. (8 February 2005). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20221115005436\/https:\/\/www.computereconomics.com\/article.cfm?id=1033\" target=\"_blank\">\"High Software Maintenance Fees and What to Do About Them\"<\/a>. <i>Computer Economics<\/i>. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.computereconomics.com\/article.cfm?id=1033\" target=\"_blank\">the original<\/a> on 15 November 2022<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20221115005436\/https:\/\/www.computereconomics.com\/article.cfm?id=1033\" target=\"_blank\">https:\/\/web.archive.org\/web\/20221115005436\/https:\/\/www.computereconomics.com\/article.cfm?id=1033<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=High+Software+Maintenance+Fees+and+What+to+Do+About+Them&rft.atitle=Computer+Economics&rft.aulast=Scavo%2C+F.&rft.au=Scavo%2C+F.&rft.date=8+February+2005&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20221115005436%2Fhttps%3A%2F%2Fwww.computereconomics.com%2Farticle.cfm%3Fid%3D1033&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/MSW,_updates,_and_other_contracted_services\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Gordon-ByrneMaint14-2\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-Gordon-ByrneMaint14_2-0\">2.0<\/a><\/sup> <sup><a href=\"#cite_ref-Gordon-ByrneMaint14_2-1\">2.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Gordon-Byrne, G. (2014). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20210505220938\/http:\/\/www.ittoday.info\/ITPerformanceImprovement\/Articles\/2014-08GordonByrne2.html\" target=\"_blank\">\"Maintenance in the Digital World\"<\/a>. <i>IT Performance Improvement<\/i>. Taylor & Francis, LLC. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ittoday.info\/ITPerformanceImprovement\/Articles\/2014-08GordonByrne2.html\" target=\"_blank\">the original<\/a> on 05 May 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20210505220938\/http:\/\/www.ittoday.info\/ITPerformanceImprovement\/Articles\/2014-08GordonByrne2.html\" target=\"_blank\">https:\/\/web.archive.org\/web\/20210505220938\/http:\/\/www.ittoday.info\/ITPerformanceImprovement\/Articles\/2014-08GordonByrne2.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Maintenance+in+the+Digital+World&rft.atitle=IT+Performance+Improvement&rft.aulast=Gordon-Byrne%2C+G.&rft.au=Gordon-Byrne%2C+G.&rft.date=2014&rft.pub=Taylor+%26+Francis%2C+LLC&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20210505220938%2Fhttp%3A%2F%2Fwww.ittoday.info%2FITPerformanceImprovement%2FArticles%2F2014-08GordonByrne2.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/MSW,_updates,_and_other_contracted_services\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230516215559\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.600 seconds\nReal time usage: 2.120 seconds\nPreprocessor visited node count: 1587\/1000000\nPost\u2010expand include size: 17292\/2097152 bytes\nTemplate argument size: 7023\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 4190\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 120.516 1 -total\n 82.39% 99.294 1 Template:Reflist\n 60.64% 73.082 2 Template:Cite_web\n 52.00% 62.663 2 Template:Citation\/core\n 17.43% 21.001 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/MSW,_updates,_and_other_contracted_services\n 14.72% 17.743 2 Template:Date\n 7.54% 9.082 6 Template:Citation\/make_link\n 4.70% 5.663 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14180-0!canonical and timestamp 20230516215559 and revision id 52002. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/MSW,_updates,_and_other_contracted_services\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/MSW,_updates,_and_other_contracted_services<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","951ce542e526420f000495fb950c810e_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/a\/a0\/Warranty_%28267038%29_-_The_Noun_Project.svg\/400px-Warranty_%28267038%29_-_The_Noun_Project.svg.png"],"951ce542e526420f000495fb950c810e_timestamp":1684275143,"f758af407ce57d327e64934c9c51b7b4_type":"article","f758af407ce57d327e64934c9c51b7b4_title":"3.2 Implementation","f758af407ce57d327e64934c9c51b7b4_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation","f758af407ce57d327e64934c9c51b7b4_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Choosing laboratory informatics software for your manufacturing lab\/ImplementationFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n3.2 Implementation \nIf you've ever worked through a system implementation process with a vendor, it was hopefully a smooth process. However, there are plenty of horror stories out there, highlighting the need of the laboratory to discuss in detail how a potential vendor will handle installation, validation, and training for the informatics solution. Does the vendor truly understand the industry and your needs? Does the vendor assign a project manager who will work with you, from planning to go-live and beyond? Can they offer you references of other labs who have gone through implementation so you can compare notes with those labs? How much attention does the potential vendor give to related issues such as data integrity of migrated data? Do they have the means to properly handle your legacy data? And are they able to work with your schedule, even if it means implementing software at off-peak work hours?[1][2]\nAs you finally get down to the ultimate decision on which vendor to work with, you may wish to start setting up an implementation checklist as part of your early project planning. Do you receive a help desk account as part of the implementation process, and if so, what information is included? If not, you'll need to keep track of specific details such as business associate agreement (BAA), sales agreement, scope documents, welcome letters, documentation, and approved staff who can utilize the vendor's support. You'll likely need to share other configuration details with the vendor, including time zone requirements, DNS and URL requirements, up-time monitors, and administrative account requirements. Finally, you'll want to ensure you and the vendor are on the same page concerning any additional customization, integration, and system validation requirements, ensuring the roll-out period is pain-free and efficient.\n\n3.2.1 Internal and external integrations \nManufacturing-based labs acquire data management software for many reasons, including improving accuracy, saving time, increasing productivity, and adding capabilities. One way of doing all of those activities is to integrate or interface the manufacturer's systems, databases, and instruments so that human error is greatly reduced or eliminated, workflows are automated and sped up, and each component's capabilities are brought into play in the most efficient and effective ways possible. In the world of manufacturing, choosing what gets integrated makes for a challenging decision, however, given the other systems that may be at work in the organization. Other systems that may used in the manufacturing enterprise include:\n\nmanufacturing execution systems (MES)\nquality management systems (QMS)\nenterprise resource planning systems (ERP)\nsupervisory control and data acquisition systems (SCADA)\nstatistical process control systems (SPC)\nproduct life cycle management systems (PLM)\ndistributed control systems (DCS)\nThese systems all have their strengths within the manufacturing enterprise but typically lack functionality necessary for laboratory processes. Not all systems need to be integrated with a laboratory system like a LIMS, but some may benefit, for example with the MES and QMS.[3][4][5][6] As such, you'll want to inquire with the vendor about its solution's hardware and software integration capabilities. Is it designed to interface with every laboratory instrument or software that can output any readable electronic file? Or are integrations limited to certain instruments and systems? How does it connect, i.e., what protocols does the software depend on to connect with other systems? Does the system allow a user to map their own file imports and exports? Can system processes be set to detect new instances of file outputs at regular intervals? Ask these and other questions to make sure the vendor clearly describes what internal and external integrations are supported with their application.\nIn many cases, a vendor's LIMS solution will have instrument integration capability built into the software, but occasionally such interfaces are separate from the main software. Today's instrument interfaces are generally built on standardized communication protocols such as RS-232, RS-422, IEEE-488 (GPIB), USB, Ethernet, and more.[7] The LIMS that can support such instrument integrations is increasingly vital to the manufacturing-based laboratory. Manufacturing labs may also want their laboratory informatics solution to be able to communicate with other software and databases. This is often done using application programming interfaces (APIs) that depend on web services implementation protocols such as REST and SOAP.[8][9][10] These messaging protocols actually allow for the creation of an API that receives communication requests and sends responses between two software systems. A more practical example is wanting your laboratory informatics solution to communicate with an enterprise resource planning (ERP) application. Perhaps the ERP system needs to create sample batches within the informatics solution, and when testing is done, have the results returned to the ERP. APIs and communication protocols make this happen.[9]\n\nReferences \n\n\n\u2191 Wagner, M. (10 October 2019). \"7 Software Implementation Challenges and How to Solve Them\". WalkMe Blog. WalkMe Ltd. https:\/\/blog.walkme.com\/7-software-implementation-challenges\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Mura, A. (12 July 2018). \"Bullet-Proof Software Implementation Plan: Challenges and Tactics\". Userlane Digital Adoption Blog. Userlane GmbH. Archived from the original on 18 April 2021. https:\/\/web.archive.org\/web\/20210418093657\/https:\/\/www.userlane.com\/software-implementation-plan\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Boyar, Kyle; Pham, Andrew; Swantek, Shannon; Ward, Gary; Herman, Gary (2021), Opie, Shaun R., ed., \"Laboratory Information Management Systems (LIMS)\" (in en), Cannabis Laboratory Fundamentals (Cham: Springer International Publishing): 131\u2013151, doi:10.1007\/978-3-030-62716-4_7, ISBN 978-3-030-62715-7, http:\/\/link.springer.com\/10.1007\/978-3-030-62716-4_7 . Retrieved 2023-05-03   \n \n\n\u2191 McDonald, J. (5 April 2023). \"Key differences between MES and LIMS in battery QA\". The Connected Lab. Thermo Fisher Scientific. https:\/\/www.thermofisher.com\/blog\/connectedlab\/key-differences-between-mes-and-lims-in-battery-qa\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Becks, M.B. (2021). \"Implementation of MES at Small EMS Providers\". University of Twente. https:\/\/purl.utwente.nl\/essays\/87515 . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Automate Production Even More: Laboratory Management Information Systems (LIMS) in Manufacturing Execution System (MES)\". Soft Industry Blog. Soft Industry. 21 February 2023. https:\/\/soft-industry.com\/blog\/lims-in-mes\/ .   \n \n\n\u2191 Williams, C.D.H.. \"Computer Interfaces for Instrumentation Systems\". University of Exeter. https:\/\/newton.ex.ac.uk\/teaching\/CDHW\/Interfaces\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Monus, A. (17 October 2022). \"SOAP vs REST vs JSON - a 2023 comparison\". Raygun. https:\/\/raygun.com\/blog\/soap-vs-rest-vs-json\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 9.0 9.1 LabVantage Solutions (7 January 2018). \"A Quick Guide to LIMS Web Services\". LabVantage Solutions, Inc. https:\/\/www.labvantage.com\/a-quick-guide-to-lims-web-services\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Grand, A.; Geda, E.; Mignone, A. et al. (2019). \"One tool to find them all: A case of data integration and querying in a distributed LIMS platform\". Database 2019: baz004. doi:10.1093\/database\/baz004.   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 21:55.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 2 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","f758af407ce57d327e64934c9c51b7b4_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Choosing_laboratory_informatics_software_for_your_manufacturing_lab_Implementation rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Choosing_laboratory_informatics_software_for_your_manufacturing_lab_Implementation skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Choosing laboratory informatics software for your manufacturing lab\/Implementation<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"3.2_Implementation\">3.2 Implementation<\/span><\/h3>\n<p>If you've ever worked through a system implementation process with a vendor, it was hopefully a smooth process. However, there are plenty of horror stories out there, highlighting the need of the laboratory to discuss in detail how a potential vendor will handle installation, validation, and training for the informatics solution. Does the vendor truly understand the industry and your needs? Does the vendor assign a project manager who will work with you, from planning to go-live and beyond? Can they offer you references of other labs who have gone through implementation so you can compare notes with those labs? How much attention does the potential vendor give to related issues such as data integrity of migrated data? Do they have the means to properly handle your legacy data? And are they able to work with your schedule, even if it means implementing software at off-peak work hours?<sup id=\"rdp-ebb-cite_ref-Wagner7Soft19_1-0\" class=\"reference\"><a href=\"#cite_note-Wagner7Soft19-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MuraBullet18_2-0\" class=\"reference\"><a href=\"#cite_note-MuraBullet18-2\">[2]<\/a><\/sup>\n<\/p><p>As you finally get down to the ultimate decision on which vendor to work with, you may wish to start setting up an implementation checklist as part of your early project planning. Do you receive a help desk account as part of the implementation process, and if so, what information is included? If not, you'll need to keep track of specific details such as business associate agreement (BAA), sales agreement, scope documents, welcome letters, documentation, and approved staff who can utilize the vendor's support. You'll likely need to share other configuration details with the vendor, including time zone requirements, DNS and URL requirements, up-time monitors, and administrative account requirements. Finally, you'll want to ensure you and the vendor are on the same page concerning any additional customization, integration, and system validation requirements, ensuring the roll-out period is pain-free and efficient.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.2.1_Internal_and_external_integrations\">3.2.1 Internal and external integrations<\/span><\/h4>\n<p>Manufacturing-based labs acquire data management software for many reasons, including improving accuracy, saving time, increasing productivity, and adding capabilities. One way of doing all of those activities is to integrate or interface the manufacturer's systems, databases, and instruments so that human error is greatly reduced or eliminated, workflows are automated and sped up, and each component's capabilities are brought into play in the most efficient and effective ways possible. In the world of manufacturing, choosing what gets integrated makes for a challenging decision, however, given the other systems that may be at work in the organization. Other systems that may used in the manufacturing enterprise include:\n<\/p>\n<ul><li>manufacturing execution systems (MES)<\/li>\n<li>quality management systems (QMS)<\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Enterprise_resource_planning\" title=\"Enterprise resource planning\" class=\"wiki-link\" data-key=\"07be791b94a208f794e38224f0c0950b\">enterprise resource planning systems<\/a> (ERP)<\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/SCADA\" title=\"SCADA\" class=\"wiki-link\" data-key=\"2e9d1c3a7073bee59b3d3b6e5aca466d\">supervisory control and data acquisition systems<\/a> (SCADA)<\/li>\n<li>statistical process control systems (SPC)<\/li>\n<li>product life cycle management systems (PLM)<\/li>\n<li>distributed control systems (DCS)<\/li><\/ul>\n<p>These systems all have their strengths within the manufacturing enterprise but typically lack functionality necessary for laboratory processes. Not all systems need to be integrated with a laboratory system like a LIMS, but some may benefit, for example with the MES and QMS.<sup id=\"rdp-ebb-cite_ref-:0_3-0\" class=\"reference\"><a href=\"#cite_note-:0-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-McDonaldKey23_4-0\" class=\"reference\"><a href=\"#cite_note-McDonaldKey23-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BecksImplem21_5-0\" class=\"reference\"><a href=\"#cite_note-BecksImplem21-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SIAutomate23_6-0\" class=\"reference\"><a href=\"#cite_note-SIAutomate23-6\">[6]<\/a><\/sup> As such, you'll want to inquire with the vendor about its solution's hardware and software integration capabilities. Is it designed to interface with every laboratory instrument or software that can output any readable electronic file? Or are integrations limited to certain instruments and systems? How does it connect, i.e., what protocols does the software depend on to connect with other systems? Does the system allow a user to map their own file imports and exports? Can system processes be set to detect new instances of file outputs at regular intervals? Ask these and other questions to make sure the vendor clearly describes what internal and external integrations are supported with their application.\n<\/p><p>In many cases, a vendor's LIMS solution will have instrument integration capability built into the software, but occasionally such interfaces are separate from the main software. Today's instrument interfaces are generally built on standardized communication protocols such as RS-232, RS-422, IEEE-488 (GPIB), USB, Ethernet, and more.<sup id=\"rdp-ebb-cite_ref-WilliamsComp_7-0\" class=\"reference\"><a href=\"#cite_note-WilliamsComp-7\">[7]<\/a><\/sup> The LIMS that can support such instrument integrations is increasingly vital to the manufacturing-based laboratory. Manufacturing labs may also want their laboratory informatics solution to be able to communicate with other software and databases. This is often done using <a href=\"https:\/\/www.limswiki.org\/index.php\/Application_programming_interface\" title=\"Application programming interface\" class=\"wiki-link\" data-key=\"36fc319869eba4613cb0854b421b0934\">application programming interfaces<\/a> (APIs) that depend on web services implementation protocols such as REST and SOAP.<sup id=\"rdp-ebb-cite_ref-MonusSOAP19_8-0\" class=\"reference\"><a href=\"#cite_note-MonusSOAP19-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LVAQuick18_9-0\" class=\"reference\"><a href=\"#cite_note-LVAQuick18-9\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GrandOneTool19_10-0\" class=\"reference\"><a href=\"#cite_note-GrandOneTool19-10\">[10]<\/a><\/sup> These messaging protocols actually allow for the creation of an API that receives communication requests and sends responses between two software systems. A more practical example is wanting your laboratory informatics solution to communicate with an <a href=\"https:\/\/www.limswiki.org\/index.php\/Enterprise_resource_planning\" title=\"Enterprise resource planning\" class=\"wiki-link\" data-key=\"07be791b94a208f794e38224f0c0950b\">enterprise resource planning<\/a> (ERP) application. Perhaps the ERP system needs to create sample batches within the informatics solution, and when testing is done, have the results returned to the ERP. APIs and communication protocols make this happen.<sup id=\"rdp-ebb-cite_ref-LVAQuick18_9-1\" class=\"reference\"><a href=\"#cite_note-LVAQuick18-9\">[9]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-Wagner7Soft19-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Wagner7Soft19_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Wagner, M. (10 October 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.walkme.com\/7-software-implementation-challenges\/\" target=\"_blank\">\"7 Software Implementation Challenges and How to Solve Them\"<\/a>. <i>WalkMe Blog<\/i>. WalkMe Ltd<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.walkme.com\/7-software-implementation-challenges\/\" target=\"_blank\">https:\/\/blog.walkme.com\/7-software-implementation-challenges\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=7+Software+Implementation+Challenges+and+How+to+Solve+Them&rft.atitle=WalkMe+Blog&rft.aulast=Wagner%2C+M.&rft.au=Wagner%2C+M.&rft.date=10+October+2019&rft.pub=WalkMe+Ltd&rft_id=https%3A%2F%2Fblog.walkme.com%2F7-software-implementation-challenges%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MuraBullet18-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MuraBullet18_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Mura, A. (12 July 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20210418093657\/https:\/\/www.userlane.com\/software-implementation-plan\/\" target=\"_blank\">\"Bullet-Proof Software Implementation Plan: Challenges and Tactics\"<\/a>. <i>Userlane Digital Adoption Blog<\/i>. Userlane GmbH. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.userlane.com\/software-implementation-plan\/\" target=\"_blank\">the original<\/a> on 18 April 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20210418093657\/https:\/\/www.userlane.com\/software-implementation-plan\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20210418093657\/https:\/\/www.userlane.com\/software-implementation-plan\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Bullet-Proof+Software+Implementation+Plan%3A+Challenges+and+Tactics&rft.atitle=Userlane+Digital+Adoption+Blog&rft.aulast=Mura%2C+A.&rft.au=Mura%2C+A.&rft.date=12+July+2018&rft.pub=Userlane+GmbH&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20210418093657%2Fhttps%3A%2F%2Fwww.userlane.com%2Fsoftware-implementation-plan%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-:0-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-:0_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation\" id=\"rdp-ebb-CITEREFBoyarPhamSwantekWard2021\">Boyar, Kyle; Pham, Andrew; Swantek, Shannon; Ward, Gary; Herman, Gary (2021), Opie, Shaun R., ed., <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/link.springer.com\/10.1007\/978-3-030-62716-4_7\" target=\"_blank\">\"Laboratory Information Management Systems (LIMS)\"<\/a> (in en), <i>Cannabis Laboratory Fundamentals<\/i> (Cham: Springer International Publishing): 131\u2013151, <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2F978-3-030-62716-4_7\" target=\"_blank\">10.1007\/978-3-030-62716-4_7<\/a>, <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-3-030-62715-7<span class=\"printonly\">, <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/link.springer.com\/10.1007\/978-3-030-62716-4_7\" target=\"_blank\">http:\/\/link.springer.com\/10.1007\/978-3-030-62716-4_7<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 2023-05-03<\/span><\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Laboratory+Information+Management+Systems+%28LIMS%29&rft.jtitle=Cannabis+Laboratory+Fundamentals&rft.aulast=Boyar&rft.aufirst=Kyle&rft.au=Boyar%2C%26%2332%3BKyle&rft.au=Pham%2C%26%2332%3BAndrew&rft.au=Swantek%2C%26%2332%3BShannon&rft.au=Ward%2C%26%2332%3BGary&rft.au=Herman%2C%26%2332%3BGary&rft.date=2021&rft.pages=131%E2%80%93151&rft.place=Cham&rft.pub=Springer+International+Publishing&rft_id=info:doi\/10.1007%2F978-3-030-62716-4_7&rft.isbn=978-3-030-62715-7&rft_id=http%3A%2F%2Flink.springer.com%2F10.1007%2F978-3-030-62716-4_7&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-McDonaldKey23-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-McDonaldKey23_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">McDonald, J. (5 April 2023). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.thermofisher.com\/blog\/connectedlab\/key-differences-between-mes-and-lims-in-battery-qa\/\" target=\"_blank\">\"Key differences between MES and LIMS in battery QA\"<\/a>. <i>The Connected Lab<\/i>. Thermo Fisher Scientific<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.thermofisher.com\/blog\/connectedlab\/key-differences-between-mes-and-lims-in-battery-qa\/\" target=\"_blank\">https:\/\/www.thermofisher.com\/blog\/connectedlab\/key-differences-between-mes-and-lims-in-battery-qa\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Key+differences+between+MES+and+LIMS+in+battery+QA&rft.atitle=The+Connected+Lab&rft.aulast=McDonald%2C+J.&rft.au=McDonald%2C+J.&rft.date=5+April+2023&rft.pub=Thermo+Fisher+Scientific&rft_id=https%3A%2F%2Fwww.thermofisher.com%2Fblog%2Fconnectedlab%2Fkey-differences-between-mes-and-lims-in-battery-qa%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BecksImplem21-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BecksImplem21_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Becks, M.B. (2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/purl.utwente.nl\/essays\/87515\" target=\"_blank\">\"Implementation of MES at Small EMS Providers\"<\/a>. University of Twente<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/purl.utwente.nl\/essays\/87515\" target=\"_blank\">https:\/\/purl.utwente.nl\/essays\/87515<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Implementation+of+MES+at+Small+EMS+Providers&rft.atitle=&rft.aulast=Becks%2C+M.B.&rft.au=Becks%2C+M.B.&rft.date=2021&rft.pub=University+of+Twente&rft_id=https%3A%2F%2Fpurl.utwente.nl%2Fessays%2F87515&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SIAutomate23-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SIAutomate23_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/soft-industry.com\/blog\/lims-in-mes\/\" target=\"_blank\">\"Automate Production Even More: Laboratory Management Information Systems (LIMS) in Manufacturing Execution System (MES)\"<\/a>. <i>Soft Industry Blog<\/i>. Soft Industry. 21 February 2023<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/soft-industry.com\/blog\/lims-in-mes\/\" target=\"_blank\">https:\/\/soft-industry.com\/blog\/lims-in-mes\/<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Automate+Production+Even+More%3A+Laboratory+Management+Information+Systems+%28LIMS%29+in+Manufacturing+Execution+System+%28MES%29&rft.atitle=Soft+Industry+Blog&rft.date=21+February+2023&rft.pub=Soft+Industry&rft_id=https%3A%2F%2Fsoft-industry.com%2Fblog%2Flims-in-mes%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WilliamsComp-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WilliamsComp_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Williams, C.D.H.. <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/newton.ex.ac.uk\/teaching\/CDHW\/Interfaces\/\" target=\"_blank\">\"Computer Interfaces for Instrumentation Systems\"<\/a>. University of Exeter<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/newton.ex.ac.uk\/teaching\/CDHW\/Interfaces\/\" target=\"_blank\">https:\/\/newton.ex.ac.uk\/teaching\/CDHW\/Interfaces\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Computer+Interfaces+for+Instrumentation+Systems&rft.atitle=&rft.aulast=Williams%2C+C.D.H.&rft.au=Williams%2C+C.D.H.&rft.pub=University+of+Exeter&rft_id=https%3A%2F%2Fnewton.ex.ac.uk%2Fteaching%2FCDHW%2FInterfaces%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MonusSOAP19-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MonusSOAP19_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Monus, A. (17 October 2022). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/raygun.com\/blog\/soap-vs-rest-vs-json\/\" target=\"_blank\">\"SOAP vs REST vs JSON - a 2023 comparison\"<\/a>. <i>Raygun<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/raygun.com\/blog\/soap-vs-rest-vs-json\/\" target=\"_blank\">https:\/\/raygun.com\/blog\/soap-vs-rest-vs-json\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=SOAP+vs+REST+vs+JSON+-+a+2023+comparison&rft.atitle=Raygun&rft.aulast=Monus%2C+A.&rft.au=Monus%2C+A.&rft.date=17+October+2022&rft_id=https%3A%2F%2Fraygun.com%2Fblog%2Fsoap-vs-rest-vs-json%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LVAQuick18-9\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-LVAQuick18_9-0\">9.0<\/a><\/sup> <sup><a href=\"#cite_ref-LVAQuick18_9-1\">9.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">LabVantage Solutions (7 January 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labvantage.com\/a-quick-guide-to-lims-web-services\/\" target=\"_blank\">\"A Quick Guide to LIMS Web Services\"<\/a>. LabVantage Solutions, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.labvantage.com\/a-quick-guide-to-lims-web-services\/\" target=\"_blank\">https:\/\/www.labvantage.com\/a-quick-guide-to-lims-web-services\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=A+Quick+Guide+to+LIMS+Web+Services&rft.atitle=&rft.aulast=LabVantage+Solutions&rft.au=LabVantage+Solutions&rft.date=7+January+2018&rft.pub=LabVantage+Solutions%2C+Inc&rft_id=https%3A%2F%2Fwww.labvantage.com%2Fa-quick-guide-to-lims-web-services%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GrandOneTool19-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GrandOneTool19_10-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Grand, A.; Geda, E.; Mignone, A. et al. (2019). \"One tool to find them all: A case of data integration and querying in a distributed LIMS platform\". <i>Database<\/i> <b>2019<\/b>: baz004. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1093%2Fdatabase%2Fbaz004\" target=\"_blank\">10.1093\/database\/baz004<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=One+tool+to+find+them+all%3A+A+case+of+data+integration+and+querying+in+a+distributed+LIMS+platform&rft.jtitle=Database&rft.aulast=Grand%2C+A.%3B+Geda%2C+E.%3B+Mignone%2C+A.+et+al.&rft.au=Grand%2C+A.%3B+Geda%2C+E.%3B+Mignone%2C+A.+et+al.&rft.date=2019&rft.volume=2019&rft.pages=baz004&rft_id=info:doi\/10.1093%2Fdatabase%2Fbaz004&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230516215538\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.238 seconds\nReal time usage: 0.279 seconds\nPreprocessor visited node count: 7450\/1000000\nPost\u2010expand include size: 59051\/2097152 bytes\nTemplate argument size: 18573\/2097152 bytes\nHighest expansion depth: 19\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 16768\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 261.600 1 -total\n 90.78% 237.485 1 Template:Reflist\n 64.76% 169.425 10 Template:Citation\/core\n 50.02% 130.840 8 Template:Cite_web\n 20.34% 53.212 1 Template:Citation\n 12.31% 32.196 8 Template:Date\n 9.97% 26.090 3 Template:Citation\/identifier\n 9.11% 23.830 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation\n 8.04% 21.039 1 Template:Cite_journal\n 4.89% 12.780 16 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14179-0!canonical and timestamp 20230516215539 and revision id 52001. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","f758af407ce57d327e64934c9c51b7b4_images":[],"f758af407ce57d327e64934c9c51b7b4_timestamp":1684275143,"65f78607cbccba23967db83197332e4c_type":"article","65f78607cbccba23967db83197332e4c_title":"3.1 Evaluation and selection","65f78607cbccba23967db83197332e4c_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection","65f78607cbccba23967db83197332e4c_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Choosing laboratory informatics software for your manufacturing lab\/Evaluation and selectionFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 3. Choosing laboratory informatics software for your manufacturing lab \n\n1.1 3.1 Evaluation and selection \n\n1.1.1 3.1.1 Technology considerations \n1.1.2 3.1.2 Features and functions \n1.1.3 3.1.3 Cybersecurity considerations \n1.1.4 3.1.4 Regulatory compliance considerations \n1.1.5 3.1.5 System flexibility \n1.1.6 3.1.6 Cost considerations \n\n\n\n\n2 References \n\n\n\n3. Choosing laboratory informatics software for your manufacturing lab \nComputers in the laboratory are not a recent phenomenon. The mid-1960s saw laboratory computerization become increasingly popular[1][2][3][4][5], though that enthusiasm was often based on the potential of the computers themselves rather than their actual capabilities.[1] Laboratorians imagined potentials such as automatic sample label generation, daily log and report management, instrument interfacing and data processing, results comparisons, and time management tools. However, it would take time for some of those potentials to be realized.[1]\nIn 1970, Temple University's Marion Ball, M.A., an assistant professor in the Department of Medical Physics, conducted a survey of pathology directors in clinical laboratories that were using computers. Asking their opinions about the advantages and disadvantages of computerized systems in the lab, she received responses from directors in 15 U.S. states, as well as from three other countries. Responses included[6]:\n\nThe ability to rapidly prepare cumulative records and then to inspect them for possible errors through analysis trends has been proven to be of tremendous advantage in a number of laboratories. We can prevent errors in our analytical systems, but we are not prepared to prevent errors in the collecting of the sample, the mislabeling of the sample, or the accidental use of an incorrect sample. Thus, the ability to inspect data trends presents the only real tool that we currently have to pick out these kinds of errors. - Max E. Chilcote, Ph.D, Meyer Memorial Hospital Division\nThere is little argument about whether an operating computer system can be an advantage in a laboratory, but the most critical time is the installation and transition from a \"manual\" to a \"computer\" oriented laboratory. - Robert L. Habig, Duke University Medical Center\nReading about these potentials and opinions today, some 50 years later, we see both clear similarities and definite advances. For example, Habig's statement about transitioning from manual to more automated processes still rings true today: it can be nerve wracking and critical to get the transition right. Conversely, while the systems of decades past weren't able to \"prevent errors in the collecting of the sample, the mislabeling of the sample, or the accidental use of an incorrect sample,\" modern laboratory informatics systems provide many assurances to sample management in the lab. In many cases, activities such as label generation, reporting, results analysis, workflow control, test ordering, and broad interoperability are commonplace in modern systems.[7] And those systems continue to advance, with machine learning now finding its way into a few laboratory data management and analysis workflows.[8][9]\nWe've come a long way since the 1960s, to a point where the question is no longer \"can a computerized system help my manufacturing-based lab?\" but rather \"how do I choose and implement an informatics system to help my manufacturing-based lab?\" As the previous chapter highlighted, a wide variety of standards and regulations further drive the narrative of \"not if but when\" for informatics systems acquisition. What follows is information to help you with this necessary acquisition, while considering the technology, features, security, cost, implementation, and vendor guarantees that come with such a system.\n\r\n\n\n3.1 Evaluation and selection \nWhat exactly is a laboratory information management system (LIMS) anyway? Do I need one? What options are available and how do I compare them? What about a request for information (RFI), request for proposal (RFP), or request for quotation (RFQ)? These are questions laboratory professionals typically ponder upon finding themselves charged with the mission of finding software for their food and beverage lab. For many the task can be a daunting proposition.\nYou may know the workflow-related needs of your laboratory, but perhaps you don't know much about data management solutions like LIMS, leaving you intimidated by all the options. You'll first need to gauge your lab's informatics needs in order to determine which products are worth investigating further. Of course your lab's analysis requirements, reporting and data sharing constraints, instrument interfacing needs, barcoding and tracking requirements, quality assurance processes, etc. are very important factors. But these systems vary in numerous ways, and other important factors exist. Price should certainly be considered, although value is ultimately more important than a low price. Other important questions that get asked include: \n\nShould we purchase software licenses or \"rent\" the software via a subscription-based model?\nDoes the software need to be on-site, or is a SaaS hosted option more practical?\nIs a modular or complete system better for us?\nWhat is the best licensing\/rental scheme for us? Should we consider site, named user, concurrent user, or workstation licenses?\nIs the company qualified and trustworthy?\nWhat functionality is available to help our lab not only accomplish workflow tasks but also remain regulatory compliant?\nThese and other questions are addressed in this chapter.\n\n3.1.1 Technology considerations \nYour laboratory's workflow, instruments, data management requirements, budget, technological expertise, business goals, and risk tolerances will all play a role in deciding what technology to invest in. The textile testing lab, for example, may depend less on instrument integration than the stability, cycle, and challenge testing lab, with its microbiological workflows. As such, look at your laboratory's short- and long-term goals, budget, workflow, and regulatory requirements to gain a better understanding of what technology will be involved.\nFirst, what are the laboratory's goals? Does the third-party laboratory owner envision a small investment, taking in a slow but steady flow of basic analytical requests, or do they envision expansive growth, expanding into multiple manufacturing-based testing domains? If the lab is starting small but is confidently expecting to grow, technological investments early on may want to take into account future technologies that may shape data management and security processes. Second, what kind of work will the lab be doing, and what regulatory responsibilities will guide hardware and software investment at the lab? If your lab will be conducting extractable and leachable testing, you'll be considering chromatography and spectroscopy instruments, as well as requirements for retaining analytical results for regulators. The accredited pharmaceutical manufacturing lab will likely have many more instruments to cover all its testing needs, and its data management system will likely need to be able to interface to U.S. Food and Drug Administration (FDA) systems, or at a minimum report in their specific format. Third, your laboratory's budget is always important. Does the budget allow for on-site hardware and software systems, with the personnel to maintain them? Is it easier to pay up-front or find a vendor willing to work with you on leasing or rental terms? (We talk about other cost considerations a bit later.) \nFinally, will the lab have someone on-site or on-call to resolve technology issues, including set-up and maintenance of software systems? If your lab will have little in the way of available tech help locally, you'll want to consider the distribution model you want to use for any installed software, i.e., you may want to consider software as a service (SaaS). An increasing number of software services are hosted using cloud computing, which when done well is an increasingly reliable option.[10] Having someone else host the software for you typically means the hosting provider will carry a non-trivial portion of responsibility for technology maintenance and security. Speaking of security, you'll also want to consider the cybersecurity (addressed later) of not only your software solution but also your overall laboratory operations. Does your organization have a cybersecurity plan already in place, or has the decision to make one been postponed? What extra investment is required to ensure your sensitive data is secure? Remember that how you rank your cybersecurity preparedness and implement a cybersecurity plan will also guide your technology investment decisions.[11]\n3.1.1.1 Laboratory informatics options\nKeeping the above in mind, what are the common software solutions used within the manufacturing-based laboratory? One of the more commonly discussed options is the LIMS, a laboratory informatics solution designed to assist laboratories with managing testing workflows, data, and other aspects of their operations. The use of LIMS in production facilities and labs is not a new concept.[12][13][14] However, little information can be found as to the percentage of today's manufacturing-based laboratories using a LIMS in their workflow. In 2020, Astrix Technology conducted a LIMS market survey, with results being compiled from \"137 professionals from a wide variety of industries,\" with some of those industries being related to manufacturing efforts. Astrix indicated some 77 percent of the surveyed companies reported having a LIMS deployment in their lab, but Astrix didn't break out those deployments by industry, making it difficult to determine what percentage of manufacturing-related companies had a LIMS deployment in 2020.[15] \nThat said, professional discussions about manufacturers and their LIMS use would seem to indicate the importance of an information management system being high in order to remain competitive in tighter economies.[16][17][18] When also taking into consideration the importance of integrating instrumentation and produced data in a manufacturing and testing environment[19][20][21], a LIMS or other informatics solution appears to be increasingly critical to eliminating manual processes, improving sample management, increasing productivity, and improving regulatory conformance.[22] This, of course, lends to the manufacturing lab's focus on safety, quality, and compliance.\nA LIMS can improve laboratory workflows and workloads while enhancing safety, quality, and compliance in a number of ways. A fragmented mix of paper-based and electronic information sources can be a detriment to the traceability of or rapid accessibility to manufacturing ingredients, additives, quality control samples, standard operating procedures (SOPs), environmental monitoring data, chain of custody data, and other vital aspects of the production of goods. A well-implemented LIMS can reduce the silos of information and data, while at the same time make that information and data more secure and readily accessible. Producers of pharmaceuticals and other goods are increasingly adding automation, and as such, a LIMS is able to better integrate and support digital data and information management while improving the adaptability and flexibility of workflows.[23] Given the regulatory demands for providing rapid proof of traceable product movement and relevant quality control data, the LIMS can also act as the central integrator and audit trail for that information.[20][24][25] Because the LIMS improves traceability\u2014including through its automated interfaces with instruments and other data systems\u2014real-time monitoring of supply chain issues, quality control data, instrument use, and more is further enabled, particularly when paired with configurable dashboards and alert mechanisms. By extension, manufacturers can more rapidly act on insights gained from those real-time dashboards.[20] This also means that the lab conducting analyses for the manufacturer can react more rapidly to issues that compromise compliance when certified to, e.g., the ISO\/IEC 17025 standard.[26][27] Finally, many modern LIMS tailored to a manufacturing-based industry come pre-configured out of the box with analytical and quality control workflow support tools that can be further optimized to a lab's unique workflow.[28]\nHowever, the LIMS is not the sole information management solution for manufacturers and the laboratories they use; they may also use a software-based quality management system (QMS) or manufacturing execution system (MES) in their operations. (We'll briefly discuss them more in section 3.2.1.) Software-based information management solutions are being marketed to manufacturing-based labs in ways other than as a LIMS. Some vendors have taken to marketing the somewhat related laboratory execution system (LES), which tends to focus more on laboratory test method execution at the process level while integrating other R&D functionalities found in, for example, electronic laboratory notebooks (ELNs).[29][30] Some software vendors incorporate artificial intelligence (AI) and machine learning (ML) mechanisms into their LIMS-like manufacturing labortatory software and package it differently, e.g., as a \"materials informatics platform\"[31] or an \"applied sciences platform.\"[32] This platform approach to software is arguably growing as a trend[33], so these laboratory informatics platforms may have utility in specific manufacturing-based labs. In comparison, some LIMS may or may not address these and other requirements; this functionality will be discussed further in the next subsection.\n\n3.1.2 Features and functions \nGiven the above, it's clear LIMS adoption and use is important to the continued success of manufacturing-based labs. However, in most cases, a generic LIMS won't do; it's imperative the lab find a solution that meets all or most of its workflow requirements. This more often than not requires a configurable solution that enables trained users to quickly make the changes they need, if those changes make sense within the overall data structure of the LIMS. It also requires a solution that has been thoughtfully developed and continues to be carefully maintained to address the ever-shifting standard- and regulation-based requirements of the manufacturing-based laboratory. The following examines both the base features and specialty requirements of a manufacturing LIMS.\n3.1.2.1 Base features\nWhat follows is a list of system functionality important to most any manufacturing-based laboratory, with a majority of that functionality found in many vendor software solutions.[20][26][24][28][29][34][35][36][37][38][39][40][41][42][43][44]\nTest, sample and result management\n\nSample log-in and management, with support for unique IDs\nSample batching\nBarcode and RFID support\nEnd-to-end sample and inventory tracking\nPre-defined and configurable industry-specific test and method management, including for bacteria (i.e., microbiology), heavy metals (i.e., chemistry), drug residues (i.e., pharmaceutical chemistry), and other substances\nPre-defined and configurable industry-specific workflows\nConfigurable screens and data fields\nSpecification management\nTest, sampling, instrument, etc. scheduling and assignment\nTest requesting\nData import and export\nRobust query tools\nAnalytical tools, including data visualization, statistical analysis, and data mining tools\nDocument and image management\nVersion control\nProject management\nMethod and protocol management\nInvestigation management\nFacility and sampling site management\nStorage management and monitoring\nContractor lab and outsourcing support\nQuality, security, and compliance\n\nQuality assurance \/ quality control mechanisms\nMechanisms for compliance with ISO\/IEC 17025 and HACCP, including support for critical control point (CCP) specifications and limits\nResult, method, protocol, batch, and material validation, review, and release\nData validation\nTrend and control charting for statistical analysis and measurement of uncertainty\nUser qualification, performance, and training management\nAudit trails and chain of custody support\nConfigurable and granular role-based security\nConfigurable system access and use (i.e., authentication requirements, account usage rules, account locking, etc.)\nElectronic signature support\nData encryption and secure communication protocols\nArchiving and retention of data and information\nConfigurable data backups\nStatus updates and alerts\nEnvironmental monitoring support\nIncident and non-conformance notification, tracking, and management\nOperations management and reporting\n\nConfigurable dashboards for monitoring, by product, process, facility, etc.\nCustomizable rich-text reporting, with multiple supported output formats\nCustom and industry-specific reporting, including certificates of analysis (CoAs)\nIndustry-compliant labeling\nEmail integration\nInstrument interfacing and data management\nThird-party software interfacing (e.g., LES, scientific data management system [SDMS], other database)\nData import, export, and archiving\nInstrument calibration and maintenance tracking\nInventory and material management\nSupplier\/vendor\/customer management\nIntegrated (or online) system help\n3.1.2.2 Specialty features\nAs noted previously, some software vendors are addressing manufacturing-based laboratories' needs beyond basic organizational LIMS functionality with their specialty solutions. A standard LIMS tailored for various manufacturing industries may already contribute to some of these wider organizational functions, as well as more advanced laboratory workflow requirements, but many may not, or may vary in what additional functionality they provide. In that regard, a LIMS vendor may also include specialized functionality that goes beyond the basic and addresses specialized activities of the manufacturer and its laboratories[29][36][38][40][41][43][45][46]:\n\nManage stability studies: From the pharmaceutical industry to the food and beverage industry, stability studies are an important specialty activity. These studies require careful statistical analysis, predictive modeling, sensory analysis, quantitative descriptive testing, discrimination testing, microbiology testing, and more. This translates to a need for a wide variety of analytical and visualization tools, as well as LIMS support for a wide variety of test methods and limits. A robust LIMS should have these abilities, but not all do.\nManage recipes and formulations, as well as master and batch production records: This functionality is more in the domain of the LES or manufacturing execution system (MES). However, a few LIMS vendors may extend their LIMS to provide these features. Given the Hazard Analysis and Critical Control Points (HACCP) rules of the food and beverage industry, as well as other master and batch record requirements for other regulated industries like the pharmaceutical industry, manufacturing labs testing batches and manufacturing materials may appreciate support in this regard.\nSupport molecular biology workflows: Molecular biology is an important tool in improving foods and beverages, ensuring the safety of pharmaceuticals, and meeting cannabis product testing requirements of state governments. However, not all LIMS are ideally equipped to handle related workflow aspects such as nucleic acid extraction, protein and cell isolation, and genotyping. A lab using such techniques may have to do extra due diligence in finding a manufacturing LIMS that also supports these workflow tasks.\nTake advantage of ELN functionality: Given the level of R&D to be found in manufacturing facilities, the ELN is a familiar companion to other informatics systems. A few LIMS vendors may have a built-in ELN with their LIMS or offer an ELN that comes readily integrated with the LIMS. Some elements of ELN functionality may even be found in a few solutions. At a minimum\u2014and nodded to in the base functionality above\u2014the LIMS should support ELN functionality through its ability to effectively connect to a third-party ELN.\nDevelop regulatory-driven safety plans: The HACCP quality control method is recommended or required for food and testing labs and is an influence on ISO\/IEC 17025, which applies to many other manufacturing labs. Some LIMS vendors have recognized this and integrated support for building HACCP steps into laboratory workflows. In some cases this may be as sophisticated as allowing the user to diagram HACCP in their lab or facility as a visualization tool.\nGenerate schedules for environmental monitoring\/testing in the facility\/lab: While a LIMS can help assign and schedule a variety of laboratory tasks, broader organizational goals of testing the production environment on a scheduled, reportable basis may not be so straightforward, particularly without facility and sampling site management functionality that allows for highlighting specific test points in the facility. Even offsite or randomized testing may not be fully supported by a generic LIMS, requiring a LIMS flexible enough to compensate for the need for broader scheduled and randomized testing and retesting.\nImprove reaction time to non-conformances: Many LIMS will have some basic form of non-conformance and incident management tools, but the robustness and extensibility of that functionality may be lacking. Can it send an SMS or email to the appropriate supplier in real-time when a pre-defined set of circumstances concerning that supplier's ingredients occurs? Can it re-prioritize or pause other related activities that are scheduled due to the identified non-conformance or incident? This is a useful area of functionality for the potential LIMS buyer to confirm with a vendor.\nImprove audit readiness and reporting: A LIMS worth its weight will have a robust audit trail, to be sure. But can your LIMS help you audit your suppliers? Can it capture internal audit data on-demand and directly from the facility floor via mobile-friendly forms? Can HACCP- and audit-related data be flagged as such to make retrieval more efficient for audit purposes? These and other considerations may be important to a manufacturing facility, and not all LIMS for manufacturers can provide that functionality.\n3.1.3 Cybersecurity considerations \nFrom law firms[47] to automotive manufacturers[48], the need to address cybersecurity is increasingly apparent. In 2018, the Center for Strategic & International Studies estimated that cybercrime causes close to $600 billion in damages to the global economy every year[49], though due to underreporting of crimes, that number may be much higher. That number also likely doesn't take into account lost business, fines, litigation, and intangible losses[50] In the end, businesses of all sizes average about $200,000 in losses due to a cybersecurity incident[51], and nearly 60 percent of small and midsize businesses go bankrupt within six months because of it.[52]\nManufacturing-based laboratories are no exception, regardless of business size. Even tiny labs whose primary digital footprint is a WordPress website advertising their lab are at risk, as hackers could still spread malware, steal user data, add the website to a bot network, hack the site for the learning experience, or even hack it just for fun.[53][54][55] Even more importantly are those labs performing digital data management tasks that handle sensitive proprietary manufacturer data, requiring additional cybersecurity considerations.\nA manufacturer and its associated laboratories can integrate cybersecurity thinking into its laboratory informatics product selection in several ways. First, the organization should have a cybersecurity plan in place, or if not, it should be on the radar. This is a good resource to tap into in regards to deciding what cybersecurity considerations should be made for the software. Can the software help your organization meet your cybersecurity goals? What regulatory requirements for your lab are or are not covered by the software?[11] Another tool to consider\u2014which may have been used in any prior cybersecurity planning efforts\u2014is a cybersecurity framework. Many, but not all, cybersecurity frameworks include a catalog of security controls. Each control is \"a safeguard or countermeasure prescribed for an information system or an organization designed to protect the confidentiality, integrity, and availability of its information and to meet a set of defined security requirements.\"[56] These controls give the implementing organization a concrete set of configurable goals to apply to their overall cybersecurity strategy. Other frameworks may be less oriented to security controls and more program-based or risk-based. Choosing the best frameworks will likely depend on multiple factors, including the organization's industry type, the amount of technical expertise within the organization, the budget, the organizational goals, the amount of buy-in from key organizational stakeholders, and those stakeholders' preferred approach.[11]\nFinally, having an organizational cybersecurity plan that incorporates one or more cybersecurity frameworks gives the laboratory ample opportunity to apply stated goals and chosen security controls to the evaluation and selection process for its informatics software. In particular, a user requirements specification (URS) that incorporates cybersecurity considerations will certainly help a laboratory with meeting regulatory requirements while also protecting its data systems. A USR that is pre-built with cybersecurity controls in mind\u2014such as LIMSpec, discussed later\u2014makes the evaluation process even easier.\n\n3.1.4 Regulatory compliance considerations \nWithout a doubt, it's vital that manufacturing-based laboratories operate within the bounds of a regulatory atmosphere, not only to better ensure the best consumer satisfaction outcomes but also to ensure the quality of analytical results, the safety of end users, and the promise of maintaining traceability across the manufacturing and distribution chain. Maintaining regulatory compliance requires deliberate approaches to developing and enforcing processes and procedures, quality training, consistent communication, and knowledgeable personnel. It also requires a top-down appreciation and commitment to a culture of quality. From ISO\/TS 22002-1:2009 Prerequisite programmes on food safety \u2014 Part 1: Food manufacturing and ISO 10993-1:2018 Biological evaluation of medical devices \u2014 Part 1: Evaluation and testing within a risk management process to 21 CFR Part 175 and 176 (concerning the materials used to package food) and current good manufacturing practice (cGMP), laboratories have much to consider in regards to what standards and regulations impact them.\nThat said, consider approaching the question of regulatory compliance from the standpoint of adopting standards. Consider first that the risks and consequences of performing a task poorly drives regulation and, more preferably[57][58], standardization, which in turn moves the \"goalposts\" of quality and security among organizations. In the case of regulations, those organization that get caught not conforming to the necessary regulations tend to suffer negative consequences, providing some incentive for them to improve organizational processes and procedures. \nOne of the downsides of regulations is that they can at times be \"imprecise\" or \"disconnected\"[58] from what actually occurs within the organization and its information systems. Rather than focusing heavily on regulatory conformance, well-designed standards may, when adopted, provide a clearer path of opportunity for organizations to improve their operational culture and outcomes, particularly since standards are usually developed with a broader consensus of interested individuals with expertise in a given field.[57] In turn, the organizations that adopt well-designed standards likely have a better chance of conforming to the regulations they must, and they'll likely have more interest in maintaining and improving the goalposts of quality and security in the lab.\nAdditionally, reputable software developers of laboratory informatics software will not only adopt their own industry standards for software development but also understand the standards and regulations that affect manufacturing-based laboratories. In turn, the developed software should meet regulations and standards, help the laboratory comply with its regulations and standards, and be of reliably good quality. \nIf you're a potential buyer of a laboratory informatics solution, it may be that you know a bit about your laboratory's workflow and a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed about all the regulations and standards that affect your lab. Turning to a URS such as LIMSpec\u2014which was developed around laboratory regulations and standards\u2014and reviewing the various statements contained within may be necessary to help further inform you. Additionally, as you investigate various informatics options, you can then use the requirements in the URS as a base for your laboratory's own requirements list. Using the categories and their subdivisions, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by the base URS. As you review the various options available to you and narrow down your search, your own list of requirements can be used as both as a personal checklist and as a requirements list you hand over to the vendor you query. And since your URS is based off the standards and regulations affecting your lab, you can feel more confident in your acquisition and its integration into your laboratory workflow.\n\n3.1.5 System flexibility \nBefore selecting a solution, your laboratory should also have internal discussions about how diversified its offered services are, as well as what the future may bring to the lab. If, for example, your lab is currently configured for microbiological testing, does your existing laboratory informatics system\u2014or the ones you may be considering\u2014have the flexibility to add other types of testing, protocols, and workflows? Will you be doing the footwork to add them, or will the vendor of your system support you in that effort? If you're a start-up, will your lab be focusing solely on a specific type of testing and expand into other types of analytical work later, or will your test menu need to be much broader right from the start? In most of these cases, you'll desire a LIMS that is flexible enough to allow for not only running the specific tests you need now, but also sufficiently expandable for any future testing services your lab may conduct in the mid- and long-term. Having the ability to create and customize sample registration screens, test protocols, labels, reports, specification limit sets, measurement units, and substrates\/matrices while being able to interface with practically most any instrument and software system required will go a long way towards making your expanding test menu and workflows integrates as smoothly as possible.\nSuch a system will typically be marketed as being highly user-configurable, giving labs a relatively painless means to adapt to rapid changes in test volume and type over time. However, once you've internally addressed current and anticipated future growth, your lab will want to learn what explicitly makes any given vendor's system user-configurable. How easy is it to configure the system to new tests? Add custom reports? What knowledge or skills will be required of your lab in order to make the necessary changes, i.e., will your staff require programming skills, or are the administrator and advanced user functions robust enough to make changes without hard-coding? These and other such questions should be fully addressed by the vendor in order to set your mind at ease towards a system's stated flexibility. Ultimately, you want the system to be flexible enough to change with the laboratory\u2014and industry\u2014itself, while minimizing overall costs and reducing the time required to make any necessary modifications.\n\n3.1.6 Cost considerations \nFirst, you'll want to be clear on what will be included in the sales agreement. Whether through an estimate or statement of work (SOW), it is important it includes exactly what is expected, being as specific as possible, since this will be the entire contractual obligation for both you the buyer and them the vendor. Note that line items may differ slightly from system to system, according to what features and functions are included by default with each vendor's solution and which, if any, are additional. Also keep in mind that any hourly amount in the the estimate or SOW is usually a best estimate; however, if sufficient attention to detailed requirements has been given, then it should be quite accurate, and in fact the final cost may even be below the quoted cost if you prioritize your own obligations so that the vendor's hours are used sparingly and efficiently. \nThe estimate or SOW should optimally include:\n\nlicensing or subscription rates;\nrequired core items to meet federal, state, and local regulations;\nadditional optional items and totals; and\nrequired services (implementation, maintenance and support, optional add-ons).\nThere are two primary ways to price a laboratory informatics solution: a one-time license fee or a subscription rate (cloud-hosted SaaS). If you have your own dedicated IT department and staff, you may prefer the former (although many system administrators are just as happy to let it be hosted elsewhere rather than add to their workload). Otherwise, a SaaS subscription may well be the better and more cost-effective way to go (since the primary IT cost is simply internet access). This item will be part of your up-front cost and, in the case of subscription, it will also figure into your first year and ongoing costs; otherwise only associated maintenance, support, and warranty (MSW) will figure in. Typically, your first year's subscription costs will be due at signing. More often, the vendor may require three months or even the first year up front, so be prepared to factor that into up-front costs. However, it still is almost always less expensive at the outset (and over time, if you factor in IT costs and annual MSW) than paying for a license fee.\nIn addition to the two types of software pricing, there are also sub-types. Generally these are based on the number of users (or, in some cases, \"nodes,\" which are simply any entities that access the informatics system, including other systems, instruments, etc.). How these are counted can vary.\n\nNamed users: This method bases pricing on the actual individual users of the system, even if they only log in sporadically. Users may not use each other's logins (this is a no-no regardless of pricing structure, for good laboratory practice and other regulatory reasons).\nConcurrent users: This bases pricing on the maximum number of users who will be logged in at any given time. You can define an unlimited number of named users in the system, each with their own login credentials. However, only the number of concurrent users specified in the license or subscription may be logged in at any one time. For example, you may have 10 staff, but due to work processes, shifts, etc., only up to six might ever be logged in simultaneously. Whereas this would require a named user license for 10, it would only require a concurrent user license for six.\nUnlimited users: In the case of very large labs (typically 30 to 50 and up), the license or subscription may simply be a flat fee that allows any number of users.\nThe line items in the estimate or SOW should reflect these nuances, as well as whether the listed costs are monthly or annual (for subscription services), hourly (typically for support and training), or a fixed one-time cost. Additionally, be cautious with fixed costs, as they typically represent one of two possible scenarios:\n\nFinal fixed cost: In this case, the cost has been figured by the vendor so as to cover their worst-case hourly labor total. If a line item (e.g., an interface) is not \"worst case,\" then you are overpaying.\n\"Expandable\" fixed cost: This is as bad as final fixed cost, and maybe even worse because it's almost a case of \"bait-and-switch,\" popping up as a surprise. The initial \"fixed cost\" number is low, and additional hourly services are needed to actually deliver the item. This will have been provided for somewhere in the small print.\nThe bottom line is that everything in a laboratory informatics solution is really either licensing or hourly services. Just be careful if they are portrayed as anything else.\nIt is important to be clear which category each line item falls under when figuring costs: up-front (due upon signing), annual, or ongoing (e.g., SaaS subscription). It is useful to clearly lay out each and compute initial costs, as well as first-year and subsequent years' costs. For example, your initial obligation may be as little as your first year's subscription plus the first 40 hours of services. Different vendors have different policies, however, and you may be required to pay for your first full year's subscription and all services, or some other combination. Normally, though, any instrument interface or other service charges aren't due until they are implemented, which may be a few weeks or even a month down the road. This may depend on your budget, complexity of the SOW, and urgency. Your first year's expenses will include everything, including initial license fees; all setup and training; any interfaces and additional configurations or customization; and first annual MSW. (If this isn't included in the SaaS subscription, then it usually commences on full system delivery). Afterwards, your subscription and MSW will be the only ongoing expenses (included as one in this example), unless you choose to have additional interfaces or other services performed at any time.\n\nReferences \n\n\n\u2191 1.0 1.1 1.2 Krieg, A.F. (1974). \"Chapter 30: Clinical Laboratory Computerization\". In Davidsohn, I.; Henry, J.B.. Clinical Diagnosis by Laboratory Methods. W.B. Saunders Company. pp. 1340\u201358. ISBN 0721629229.   \n \n\n\u2191 Flynn, F.V. (1965). \"Computer-assisted processing of bio-chemical test data\". In Atkins, H.J.B.. Progress in Medical Computing. Blackwell Science Ltd. p. 46. ISBN 0632001801.   \n \n\n\u2191 Williams, G.Z. (1964). \"The Use of Data Processing and Automation in Clinical Pathology\". Military Medicine 129 (6): 502\u20139. doi:10.1093\/milmed\/129.6.502.   \n \n\n\u2191 Hicks, G.P.; Gieschen, M.M.; Slack, W.V. et al. (1966). \"Routine Use of a Small Digital Computer in the Clinical Laboratory\". 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ISSN 1381-141X. https:\/\/www.sciencedirect.com\/science\/article\/pii\/1381141X9580027Z .   \n \n\n\u2191 Hinton, Mary D.; Hinton, Phillip R. (1996). \"LIMS and chromatographic data acquisition in the manufacturing environment\" (in en). Journal of Automatic Chemistry 18 (5): 169\u2013174. doi:10.1155\/S1463924696000181. ISSN 0142-0453. PMC PMC2548082. PMID 18925032. http:\/\/www.hindawi.com\/journals\/jamc\/1996\/723762\/abs\/ .   \n \n\n\u2191 \u00c7a\u011f\u0131nd\u0131, \u00d6zlem; \u00d6tle\u015f, Semih (1 December 2004). \"Importance of laboratory information management systems (LIMS) software for food processing factories\" (in en). Journal of Food Engineering 65 (4): 565\u2013568. doi:10.1016\/j.jfoodeng.2004.02.021.   \n \n\n\u2191 \"2020 LIMS Market Research Survey Report\" (PDT). Astrix Technology, LLC. March 2021. https:\/\/astrixinc.com\/wp-content\/uploads\/2021\/03\/Astrix-2020-LIMS-Market-Research-Report.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 Pharma Tech Outlook (2 September 2022). \"LIMS Add Competitive Advantage to CDMOs\". Pharma Tech Outlook. https:\/\/www.pharmatechoutlook.com\/news\/lims-add-competitive-advantage-to-cdmos-nwid-2386.html . Retrieved 05 May 2023 .   \n \n\n\u2191 Abazeri, L. (10 November 2022). \"How does using an integrated laboratory information management system (LIMS) improve food & beverage manufacturing quality?\". Siemens. https:\/\/blogs.sw.siemens.com\/consumer-products-retail\/2022\/11\/10\/how-does-using-an-integrated-laboratory-information-management-system-lims-improve-food-beverage-manufacturing-quality\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Frost & Sullivan (February 2021). \"Big Data Analytics and Artificial Intelligence are Driving the Global LIMS Market\". MarketResearch.com. https:\/\/www.marketresearch.com\/Frost-Sullivan-v383\/Big-Data-Analytics-Artificial-Intelligence-14233934\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Scholten, Bianca (2007). \"Chapter 4: Applying ISA-95 to Vertical Integration\". The road to integration: a guide to applying the ISA-95 standard in manufacturing. Research Triangle Park NC: ISA. pp. 167\u201393. ISBN 978-0-9792343-8-5. https:\/\/books.google.com\/books?id=-UQ0knDacZsC&pg=PA189&dq=manufacturing+system+integration+%22LIMS%22&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjTuuO0sNz-AhXHlWoFHfj9A1EQ6AF6BAgCEAI#v=onepage&q=manufacturing%20system%20integration%20%22LIMS%22&f=false .   \n \n\n\u2191 20.0 20.1 20.2 20.3 Smith, K. (2 July 2019). \"Integrated Informatics: Optimizing Food Quality and Safety by Building Regulatory Compliance into the Supply Chain\". Food Safety Tech. https:\/\/foodsafetytech.com\/feature_article\/integrated-informatics-optimizing-food-quality-and-safety-by-building-regulatory-compliance-into-the-supply-chain\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Food & Beverage Process Automation and Instrumentation\" (PDF). Siemens Industry, Inc. 2022. https:\/\/assets.new.siemens.com\/siemens\/assets\/api\/uuid:ca5438d3-5b52-4b41-aae0-aaaa3685484e\/pibr-00021-0820-food-bev-portrait.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Astrix 2020 LIMS Market Research Survey Report\" (PDF). Astrix Technology, LLC. March 2021. https:\/\/astrixinc.com\/wp-content\/uploads\/2021\/03\/Astrix-2020-LIMS-Market-Research-Report.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 Cardoso, R.; Kinscher, K.; Ruof, T. et al. (8 March 2023). \"From bench to bedside: Transforming R&D labs through automation\". McKinsey & Company. https:\/\/www.mckinsey.com\/industries\/life-sciences\/our-insights\/from-bench-to-bedside-transforming-r-and-d-labs-through-automation . Retrieved 05 May 2023 .   \n \n\n\u2191 24.0 24.1 McDermott, P. (31 July 2018). \"How Digital Solutions Support Supply Chain Transparency and Traceability\". Food Safety Tech. https:\/\/foodsafetytech.com\/column\/how-digital-solutions-support-supply-chain-transparency-and-traceability\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Evans, K. (15 November 2019). \"The Digital Transformation of Global Food Security\". Food Safety Tech. https:\/\/foodsafetytech.com\/feature_article\/the-digital-transformation-of-global-food-security\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 26.0 26.1 Apte, A. (20 October 2020). \"Is Your Food Testing Lab Prepping for an ISO\/IEC 17025 Audit?\". Food Safety Tech. https:\/\/foodsafetytech.com\/column\/is-your-food-testing-lab-prepping-for-an-iso-iec-17025-audit\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Paszko, C. (26 October 2015). \"How LIMS Facilitates ISO 17025 Certification in Food Testing Labs\". Food Safety Tech. https:\/\/foodsafetytech.com\/feature_article\/how-lims-facilitates-iso-17025-certification-in-food-testing-labs\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 28.0 28.1 Ingalls, E. (6 August 2020). \"How Advanced LIMS Brings Control, Consistency and Compliance to Food Safety\". Food Safety Tech. https:\/\/foodsafetytech.com\/feature_article\/how-advanced-lims-brings-control-consistency-and-compliance-to-food-safety\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 29.0 29.1 29.2 \"iLES Food & Beverages Lab Execution\". iVention BV. https:\/\/hs.iles.cloud\/en\/food-and-beverages-lab-execution . Retrieved 05 May 2023 .   \n \n\n\u2191 LabVantage Solutions (16 April 2020). \"How LIMS can Improve your Food and Beverage Testing Lab\". News Medical. https:\/\/www.news-medical.net\/whitepaper\/20200416\/How-LIMS-can-Improve-your-Food-and-Beverage-Testing-Lab.aspx . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Materials Informatics Platform vs. LIMS\". Materials.Zone Ltd. https:\/\/www.materials.zone\/blog\/materials-informatics-platform-vs-lims . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Make better products faster\". Alchemy Cloud, Inc. https:\/\/www.alchemy.cloud\/products\/lab-platform . Retrieved 05 May 2023 .   \n \n\n\u2191 Zhu, F.; Furr, N. (April 2016). \"Products to Platforms: Making the Leap\". Harvard Business Review. pp. 72\u20138. https:\/\/hbr.org\/2016\/04\/products-to-platforms-making-the-leap . Retrieved 05 May 2023 .   \n \n\n\u2191 Tech Net Magazine (27 September 2022). \"What Are the Features of LIMS?\". Tech Net Magazine. https:\/\/www.technetmagazine.com\/what-are-the-features-of-lims\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Role of Laboratory Information Management System in Manufacturing Sectors\". Insights Success. https:\/\/insightssuccess.com\/role-of-laboratory-information-management-system-in-manufacturing-sectors\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 36.0 36.1 \"STARLIMS General Manufacturing and Consumer Products Manufacturing Industries LIMS Specification Document\" (PDF). STARLIMS Corporation. June 2021. https:\/\/www.starlims.com\/wp-content\/uploads\/general-manufacturing-lims-spec-document.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 Goldberg, A. (27 June 2019). \"Benefits of a Laboratory Information Management System\". Labtag Blog. https:\/\/blog.labtag.com\/the-benefits-of-using-a-laboratory-information-management-system-lims\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 38.0 38.1 Rosha, V. (2005). \"LIMS: An Informatics Tool for Pharmaceutical Industries (A White Paper)\". Satyam Computer Services Ltd. https:\/\/citeseerx.ist.psu.edu\/document?repid=rep1&type=pdf&doi=5a4bc0e7d8421cb10b2740934964f44efb478bc1 . Retrieved 05 May 2023 .   \n \n\n\u2191 Thurston, C. (January 2013). \"Achieving Success in Chemical Manufacturing: How a Laboratory Information Management System (LIMS) Ensures Flexibility in the Lab\" (PDF). American Laboratory 45 (1): 1\u20133. http:\/\/www.thermoscientific.es\/content\/dam\/tfs\/ATG\/CMD\/CMD%20Documents\/Third-Party%20Papers\/Laboratory%20Information%20Management%20Systems%20(LIMS)\/D22087~.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 40.0 40.1 Russom, Diana; Ahmed, Amira; Gonzalez, Nancy; Alvarnas, Joseph; Digiusto, David (1 January 2012). \"Implementation of a configurable laboratory information management system for use in cellular process development and manufacturing\" (in en). Cytotherapy 14 (1): 114\u2013121. doi:10.3109\/14653249.2011.619007. https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1465324912706205 .   \n \n\n\u2191 41.0 41.1 Famili, Parsa; Cleary, Susan (9 March 2022), Huynh\u2010Ba, Kim, ed., \"Laboratory Information Management System (LIMS) and Electronic Data\" (in en), Analytical Testing for the Pharmaceutical GMP Laboratory (Wiley): 345\u2013373, doi:10.1002\/9781119680475.ch10, ISBN 978-1-119-12091-9, https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/9781119680475.ch10   \n \n\n\u2191 Guo, Pei; Peterson, Raymond; Paukstelis, Paul; Wang, Jianwu (2020), Yang, Hui; Qiu, Robin; Chen, Weiwei, eds., \"Cloud-Based Life Sciences Manufacturing System: Integrated Experiment Management and Data Analysis via Amazon Web Services\" (in en), Smart Service Systems, Operations Management, and Analytics (Cham: Springer International Publishing): 149\u2013159, doi:10.1007\/978-3-030-30967-1_14, ISBN 978-3-030-30966-4, http:\/\/link.springer.com\/10.1007\/978-3-030-30967-1_14   \n \n\n\u2191 43.0 43.1 \"STARLIMS Food and Beverage Industry LIMS Specification Document\" (PDF). STARLIMS Corporation. November 2021. https:\/\/www.starlims.com\/wp-content\/uploads\/food-and-bev-lims-spec-document.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 Boyar, Kyle; Pham, Andrew; Swantek, Shannon; Ward, Gary; Herman, Gary (2021), Opie, Shaun R., ed., \"Laboratory Information Management Systems (LIMS)\" (in en), Cannabis Laboratory Fundamentals (Cham: Springer International Publishing): 131\u2013151, doi:10.1007\/978-3-030-62716-4_7, ISBN 978-3-030-62715-7, http:\/\/link.springer.com\/10.1007\/978-3-030-62716-4_7 . Retrieved 2023-05-03   \n \n\n\u2191 Douglas, S.E. (May 2022). \"17. Production management\". LIMSpec 2022 R2. LIMSwiki.org. https:\/\/www.limswiki.org\/index.php?title=LII:LIMSpec\/Specialty_Laboratory_Functions#17._Production_management . Retrieved 05 May 2023 .   \n \n\n\u2191 Jayashree, B; Reddy, Praveen T; Leeladevi, Y; Crouch, Jonathan H; Mahalakshmi, V; Buhariwalla, Hutokshi K; Eshwar, Ke; Mace, Emma et al. (1 December 2006). \"Laboratory Information Management Software for genotyping workflows: applications in high throughput crop genotyping\" (in en). BMC Bioinformatics 7 (1): 383. doi:10.1186\/1471-2105-7-383. ISSN 1471-2105. PMC PMC1559653. PMID 16914063. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC1559653 .   \n \n\n\u2191 Sobowale, J. (1 March 2017). \"Law firms must manage cybersecurity risks\". ABA Journal. American Bar Association. http:\/\/www.abajournal.com\/magazine\/article\/managing_cybersecurity_risk\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Watney, C.; Draffin, C. (November 2017). \"Addressing new challenges in automotive cybersecurity\" (PDF). R Street Policy Study No. 118. R Street Institute. https:\/\/www.rstreet.org\/wp-content\/uploads\/2018\/04\/118-1.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 Lewis, J.A. (21 February 2018). \"Economic Impact of Cybercrime\". Center for Strategic & International Studies. https:\/\/www.csis.org\/analysis\/economic-impact-cybercrime . Retrieved 05 May 2023 .   \n \n\n\u2191 \"BLOG: Cost of Cyber Crime to Small Businesses\". Virginia SBDC Blog. Virginia SBDC. 30 May 2017. Archived from the original on 05 July 2020. https:\/\/web.archive.org\/web\/20200705061737\/https:\/\/www.virginiasbdc.org\/blog-cost-of-cyber-crime-to-small-businesses\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Hiscox Cyber Readiness Report 2019\" (PDF). Hiscox Ltd. April 2019. https:\/\/www.hiscox.com\/documents\/2019-Hiscox-Cyber-Readiness-Report.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 Galvin, J. (7 May 2018). \"60 Percent of Small Businesses Fold Within 6 Months of a Cyber Attack. Here's How to Protect Yourself\". Inc.com. https:\/\/www.inc.com\/joe-galvin\/60-percent-of-small-businesses-fold-within-6-months-of-a-cyber-attack-heres-how-to-protect-yourself.html . Retrieved 05 May 2023 .   \n \n\n\u2191 Grima, M. (15 June 2022). \"Top reasons why WordPress websites get hacked (and how you can stop it)\". WP White Security. https:\/\/www.wpwhitesecurity.com\/why-malicious-hacker-target-wordpress\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Moen, D. (19 April 2016). \"What Hackers Do With Compromised WordPress Sites\". Wordfence Blog. Defiant, Inc. https:\/\/www.wordfence.com\/blog\/2016\/04\/hackers-compromised-wordpress-sites\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Talaleve, A. (22 February 2022). \"Website Hacking Statistics You Should Know in 2022\". Patchstack. https:\/\/patchstack.com\/articles\/website-hacking-statistics\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"security control\". Computer Security Resource Center. National Institute of Standards and Technology. 2019. https:\/\/csrc.nist.gov\/glossary\/term\/security_control . Retrieved 05 May 2023 .   \n \n\n\u2191 57.0 57.1 Ciocoui, C.N.; Dobrea, R.C. (2010). \"Chapter 1. The Role of Standardization in Improving the Effectiveness of Integrated Risk Management\". In Nota, G.. Advances in Risk Management. IntechOpen. doi:10.5772\/9893. ISBN 9789535159469.   \n \n\n\u2191 58.0 58.1 \"Data Standardization: A Call to Action\" (PDF). JPMorgan Chase & Co. May 2018. https:\/\/www.jpmorganchase.com\/content\/dam\/jpmc\/jpmorgan-chase-and-co\/documents\/call-to-action.pdf . Retrieved 05 May 2023 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 21:55.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 3 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","65f78607cbccba23967db83197332e4c_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Choosing_laboratory_informatics_software_for_your_manufacturing_lab_Evaluation_and_selection rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Choosing_laboratory_informatics_software_for_your_manufacturing_lab_Evaluation_and_selection skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Choosing laboratory informatics software for your manufacturing lab\/Evaluation and selection<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h2><span class=\"mw-headline\" id=\"3._Choosing_laboratory_informatics_software_for_your_manufacturing_lab\">3. Choosing laboratory informatics software for your manufacturing lab<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Microwave_Microsystems_Laboratory_-_51997578036.jpg\" class=\"image wiki-link\" data-key=\"21ee52d956f6f6b86be2b5d92e691441\"><img alt=\"Microwave Microsystems Laboratory - 51997578036.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/50\/Microwave_Microsystems_Laboratory_-_51997578036.jpg\" decoding=\"async\" width=\"250\" height=\"375\" \/><\/a><\/div><p>Computers in the laboratory are not a recent phenomenon. The mid-1960s saw laboratory computerization become increasingly popular<sup id=\"rdp-ebb-cite_ref-KriegClinical74_1-0\" class=\"reference\"><a href=\"#cite_note-KriegClinical74-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FlynnComputer65_2-0\" class=\"reference\"><a href=\"#cite_note-FlynnComputer65-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WilliamsTheUse64_3-0\" class=\"reference\"><a href=\"#cite_note-WilliamsTheUse64-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HicksRoutine66_4-0\" class=\"reference\"><a href=\"#cite_note-HicksRoutine66-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-StraumfjordElectronic67_5-0\" class=\"reference\"><a href=\"#cite_note-StraumfjordElectronic67-5\">[5]<\/a><\/sup>, though that enthusiasm was often based on the potential of the computers themselves rather than their actual capabilities.<sup id=\"rdp-ebb-cite_ref-KriegClinical74_1-1\" class=\"reference\"><a href=\"#cite_note-KriegClinical74-1\">[1]<\/a><\/sup> Laboratorians imagined potentials such as automatic sample label generation, daily log and report management, instrument interfacing and data processing, results comparisons, and time management tools. However, it would take time for some of those potentials to be realized.<sup id=\"rdp-ebb-cite_ref-KriegClinical74_1-2\" class=\"reference\"><a href=\"#cite_note-KriegClinical74-1\">[1]<\/a><\/sup>\n<\/p><p>In 1970, Temple University's Marion Ball, M.A., an assistant professor in the Department of Medical Physics, conducted a survey of pathology directors in clinical laboratories that were using computers. Asking their opinions about the advantages and disadvantages of computerized systems in the lab, she received responses from directors in 15 U.S. states, as well as from three other countries. Responses included<sup id=\"rdp-ebb-cite_ref-BallASurvey70_6-0\" class=\"reference\"><a href=\"#cite_note-BallASurvey70-6\">[6]<\/a><\/sup>:\n<\/p>\n<blockquote><p><i>The ability to rapidly prepare cumulative records and then to inspect them for possible errors through analysis trends has been proven to be of tremendous advantage in a number of laboratories. We can prevent errors in our analytical systems, but we are not prepared to prevent errors in the collecting of the sample, the mislabeling of the sample, or the accidental use of an incorrect sample. Thus, the ability to inspect data trends presents the only real tool that we currently have to pick out these kinds of errors.<\/i> - Max E. Chilcote, Ph.D, Meyer Memorial Hospital Division<\/p><\/blockquote>\n<blockquote><p><i>There is little argument about whether an operating computer system can be an advantage in a laboratory, but the most critical time is the installation and transition from a \"manual\" to a \"computer\" oriented laboratory.<\/i> - Robert L. Habig, Duke University Medical Center<\/p><\/blockquote>\n<p>Reading about these potentials and opinions today, some 50 years later, we see both clear similarities and definite advances. For example, Habig's statement about transitioning from manual to more automated processes still rings true today: it can be nerve wracking and critical to get the transition right. Conversely, while the systems of decades past weren't able to \"prevent errors in the collecting of the sample, the mislabeling of the sample, or the accidental use of an incorrect sample,\" modern <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> systems provide many assurances to sample management in the lab. In many cases, activities such as label generation, reporting, results analysis, <a href=\"https:\/\/www.limswiki.org\/index.php\/Workflow\" title=\"Workflow\" class=\"wiki-link\" data-key=\"92bd8748272e20d891008dcb8243e8a8\">workflow<\/a> control, test ordering, and broad interoperability are commonplace in modern systems.<sup id=\"rdp-ebb-cite_ref-JonesInformatics14_7-0\" class=\"reference\"><a href=\"#cite_note-JonesInformatics14-7\">[7]<\/a><\/sup> And those systems continue to advance, with <a href=\"https:\/\/www.limswiki.org\/index.php\/Machine_learning\" title=\"Machine learning\" class=\"wiki-link\" data-key=\"79aab39cfa124c958cd1dbcab3dde122\">machine learning<\/a> now finding its way into a few laboratory data management and <a href=\"https:\/\/www.limswiki.org\/index.php\/Data_analysis\" title=\"Data analysis\" class=\"wiki-link\" data-key=\"545c95e40ca67c9e63cd0a16042a5bd1\">analysis<\/a> workflows.<sup id=\"rdp-ebb-cite_ref-BurtonNHS18_8-0\" class=\"reference\"><a href=\"#cite_note-BurtonNHS18-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CuffAugment18_9-0\" class=\"reference\"><a href=\"#cite_note-CuffAugment18-9\">[9]<\/a><\/sup>\n<\/p><p>We've come a long way since the 1960s, to a point where the question is no longer \"can a computerized system help my manufacturing-based lab?\" but rather \"how do I choose and implement an informatics system to help my manufacturing-based lab?\" As the previous chapter highlighted, a wide variety of standards and regulations further drive the narrative of \"not if but when\" for informatics systems acquisition. What follows is information to help you with this necessary acquisition, while considering the technology, features, security, cost, implementation, and vendor guarantees that come with such a system.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"3.1_Evaluation_and_selection\">3.1 Evaluation and selection<\/span><\/h3>\n<p>What exactly is a <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS) anyway? Do I need one? What options are available and how do I compare them? What about a request for information (RFI), request for proposal (RFP), or request for quotation (RFQ)? These are questions <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> professionals typically ponder upon finding themselves charged with the mission of finding software for their food and beverage lab. For many the task can be a daunting proposition.\n<\/p><p>You may know the workflow-related needs of your laboratory, but perhaps you don't know much about <a href=\"https:\/\/www.limswiki.org\/index.php\/Information_management\" title=\"Information management\" class=\"wiki-link\" data-key=\"f8672d270c0750a858ed940158ca0a73\">data management<\/a> solutions like LIMS, leaving you intimidated by all the options. You'll first need to gauge your lab's informatics needs in order to determine which products are worth investigating further. Of course your lab's analysis requirements, reporting and data sharing constraints, instrument interfacing needs, <a href=\"https:\/\/www.limswiki.org\/index.php\/Barcode\" title=\"Barcode\" class=\"wiki-link\" data-key=\"e0952b5b262392be0995237aec36d355\">barcoding<\/a> and tracking requirements, quality assurance processes, etc. are very important factors. But these systems vary in numerous ways, and other important factors exist. Price should certainly be considered, although value is ultimately more important than a low price. Other important questions that get asked include: \n<\/p>\n<ul><li>Should we purchase software licenses or \"rent\" the software via a subscription-based model?<\/li>\n<li>Does the software need to be on-site, or is a <a href=\"https:\/\/www.limswiki.org\/index.php\/Software_as_a_service\" title=\"Software as a service\" class=\"wiki-link\" data-key=\"ae8c8a7cd5ee1a264f4f0bbd4a4caedd\">SaaS<\/a> hosted option more practical?<\/li>\n<li>Is a modular or complete system better for us?<\/li>\n<li>What is the best licensing\/rental scheme for us? Should we consider site, named user, concurrent user, or workstation licenses?<\/li>\n<li>Is the company qualified and trustworthy?<\/li>\n<li>What functionality is available to help our lab not only accomplish workflow tasks but also remain regulatory compliant?<\/li><\/ul>\n<p>These and other questions are addressed in this chapter.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.1.1_Technology_considerations\">3.1.1 Technology considerations<\/span><\/h4>\n<p>Your laboratory's <a href=\"https:\/\/www.limswiki.org\/index.php\/Workflow\" title=\"Workflow\" class=\"wiki-link\" data-key=\"92bd8748272e20d891008dcb8243e8a8\">workflow<\/a>, instruments, data management requirements, budget, technological expertise, business goals, and risk tolerances will all play a role in deciding what technology to invest in. The textile testing lab, for example, may depend less on instrument integration than the stability, cycle, and challenge testing lab, with its microbiological workflows. As such, look at your laboratory's short- and long-term goals, budget, workflow, and regulatory requirements to gain a better understanding of what technology will be involved.\n<\/p><p>First, what are the laboratory's goals? Does the third-party laboratory owner envision a small investment, taking in a slow but steady flow of basic analytical requests, or do they envision expansive growth, expanding into multiple manufacturing-based testing domains? If the lab is starting small but is confidently expecting to grow, technological investments early on may want to take into account future technologies that may shape data management and security processes. Second, what kind of work will the lab be doing, and what regulatory responsibilities will guide hardware and software investment at the lab? If your lab will be conducting extractable and leachable testing, you'll be considering <a href=\"https:\/\/www.limswiki.org\/index.php\/Chromatography\" title=\"Chromatography\" class=\"wiki-link\" data-key=\"2615535d1f14c6cffdfad7285999ad9d\">chromatography<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Spectroscopy\" title=\"Spectroscopy\" class=\"wiki-link\" data-key=\"2babfd09e1f6d00d86ad7032cbb60d91\">spectroscopy<\/a> instruments, as well as requirements for retaining analytical results for regulators. The accredited pharmaceutical manufacturing lab will likely have many more instruments to cover all its testing needs, and its data management system will likely need to be able to interface to U.S. Food and Drug Administration (FDA) systems, or at a minimum report in their specific format. Third, your laboratory's budget is always important. Does the budget allow for on-site hardware and software systems, with the personnel to maintain them? Is it easier to pay up-front or find a vendor willing to work with you on leasing or rental terms? (We talk about other cost considerations a bit later.) \n<\/p><p>Finally, will the lab have someone on-site or on-call to resolve technology issues, including set-up and maintenance of software systems? If your lab will have little in the way of available tech help locally, you'll want to consider the distribution model you want to use for any installed software, i.e., you may want to consider <a href=\"https:\/\/www.limswiki.org\/index.php\/Software_as_a_service\" title=\"Software as a service\" class=\"wiki-link\" data-key=\"ae8c8a7cd5ee1a264f4f0bbd4a4caedd\">software as a service<\/a> (SaaS). An increasing number of software services are hosted using <a href=\"https:\/\/www.limswiki.org\/index.php\/Cloud_computing\" title=\"Cloud computing\" class=\"wiki-link\" data-key=\"fcfe5882eaa018d920cedb88398b604f\">cloud computing<\/a>, which when done well is an increasingly reliable option.<sup id=\"rdp-ebb-cite_ref-IzrailevskyCloud18_10-0\" class=\"reference\"><a href=\"#cite_note-IzrailevskyCloud18-10\">[10]<\/a><\/sup> Having someone else host the software for you typically means the hosting provider will carry a non-trivial portion of responsibility for technology maintenance and security. Speaking of security, you'll also want to consider the <a href=\"https:\/\/www.limswiki.org\/index.php\/Cybersecurity\" class=\"mw-redirect wiki-link\" title=\"Cybersecurity\" data-key=\"ba653dc2a1384e5f9f6ac9dc1a740109\">cybersecurity<\/a> (addressed later) of not only your software solution but also your overall laboratory operations. Does your organization have a cybersecurity plan already in place, or has the decision to make one been postponed? What extra investment is required to ensure your sensitive data is secure? Remember that how you rank your cybersecurity preparedness and implement a cybersecurity plan will also guide your technology investment decisions.<sup id=\"rdp-ebb-cite_ref-DouglasComp20_11-0\" class=\"reference\"><a href=\"#cite_note-DouglasComp20-11\">[11]<\/a><\/sup>\n<\/p><p><b>3.1.1.1 Laboratory informatics options<\/b>\n<\/p><p>Keeping the above in mind, what are the common software solutions used within the manufacturing-based laboratory? One of the more commonly discussed options is the LIMS, a laboratory informatics solution designed to assist laboratories with managing testing workflows, data, and other aspects of their operations. The use of LIMS in production facilities and labs is not a new concept.<sup id=\"rdp-ebb-cite_ref-HintonLIMSIn95_12-0\" class=\"reference\"><a href=\"#cite_note-HintonLIMSIn95-12\">[12]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HintonLIMS96_13-0\" class=\"reference\"><a href=\"#cite_note-HintonLIMS96-13\">[13]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-14\" class=\"reference\"><a href=\"#cite_note-14\">[14]<\/a><\/sup> However, little information can be found as to the percentage of today's manufacturing-based laboratories using a LIMS in their workflow. In 2020, Astrix Technology conducted a LIMS market survey, with results being compiled from \"137 professionals from a wide variety of industries,\" with some of those industries being related to manufacturing efforts. Astrix indicated some 77 percent of the surveyed companies reported having a LIMS deployment in their lab, but Astrix didn't break out those deployments by industry, making it difficult to determine what percentage of manufacturing-related companies had a LIMS deployment in 2020.<sup id=\"rdp-ebb-cite_ref-AstrixLIMS21_15-0\" class=\"reference\"><a href=\"#cite_note-AstrixLIMS21-15\">[15]<\/a><\/sup> \n<\/p><p>That said, professional discussions about manufacturers and their LIMS use would seem to indicate the importance of an information management system being high in order to remain competitive in tighter economies.<sup id=\"rdp-ebb-cite_ref-PTOLIMS22_16-0\" class=\"reference\"><a href=\"#cite_note-PTOLIMS22-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AbazeriHowDoes22_17-0\" class=\"reference\"><a href=\"#cite_note-AbazeriHowDoes22-17\">[17]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-F.26SBigData21_18-0\" class=\"reference\"><a href=\"#cite_note-F.26SBigData21-18\">[18]<\/a><\/sup> When also taking into consideration the importance of integrating instrumentation and produced data in a manufacturing and testing environment<sup id=\"rdp-ebb-cite_ref-19\" class=\"reference\"><a href=\"#cite_note-19\">[19]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SmithInteg19_20-0\" class=\"reference\"><a href=\"#cite_note-SmithInteg19-20\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SiemensProcess22_21-0\" class=\"reference\"><a href=\"#cite_note-SiemensProcess22-21\">[21]<\/a><\/sup>, a LIMS or other informatics solution appears to be increasingly critical to eliminating manual processes, improving sample management, increasing productivity, and improving regulatory conformance.<sup id=\"rdp-ebb-cite_ref-Astrix2020LIMS_22-0\" class=\"reference\"><a href=\"#cite_note-Astrix2020LIMS-22\">[22]<\/a><\/sup> This, of course, lends to the manufacturing lab's focus on safety, quality, and compliance.\n<\/p><p>A LIMS can improve laboratory workflows and workloads while enhancing safety, quality, and compliance in a number of ways. A fragmented mix of paper-based and electronic information sources can be a detriment to the traceability of or rapid accessibility to manufacturing ingredients, additives, quality control samples, standard operating procedures (SOPs), environmental monitoring data, chain of custody data, and other vital aspects of the production of goods. A well-implemented LIMS can reduce the silos of information and data, while at the same time make that information and data more secure and readily accessible. Producers of pharmaceuticals and other goods are increasingly adding automation, and as such, a LIMS is able to better integrate and support digital data and information management while improving the adaptability and flexibility of workflows.<sup id=\"rdp-ebb-cite_ref-CardosoFromBench23_23-0\" class=\"reference\"><a href=\"#cite_note-CardosoFromBench23-23\">[23]<\/a><\/sup> Given the regulatory demands for providing rapid proof of traceable product movement and relevant quality control data, the LIMS can also act as the central integrator and audit trail for that information.<sup id=\"rdp-ebb-cite_ref-SmithInteg19_20-1\" class=\"reference\"><a href=\"#cite_note-SmithInteg19-20\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-McDermottHowDig18_24-0\" class=\"reference\"><a href=\"#cite_note-McDermottHowDig18-24\">[24]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EvansTheDig19_25-0\" class=\"reference\"><a href=\"#cite_note-EvansTheDig19-25\">[25]<\/a><\/sup> Because the LIMS improves traceability\u2014including through its automated interfaces with instruments and other data systems\u2014real-time monitoring of supply chain issues, quality control data, instrument use, and more is further enabled, particularly when paired with configurable dashboards and alert mechanisms. By extension, manufacturers can more rapidly act on insights gained from those real-time dashboards.<sup id=\"rdp-ebb-cite_ref-SmithInteg19_20-2\" class=\"reference\"><a href=\"#cite_note-SmithInteg19-20\">[20]<\/a><\/sup> This also means that the lab conducting analyses for the manufacturer can react more rapidly to issues that compromise compliance when certified to, e.g., the <a href=\"https:\/\/www.limswiki.org\/index.php\/ISO_17025\" class=\"mw-redirect wiki-link\" title=\"ISO 17025\" data-key=\"e8525a8d5d35bc9c3c1015749eb8de05\">ISO\/IEC 17025<\/a> standard.<sup id=\"rdp-ebb-cite_ref-ApteIsYour20_26-0\" class=\"reference\"><a href=\"#cite_note-ApteIsYour20-26\">[26]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PaszkoHow15_27-0\" class=\"reference\"><a href=\"#cite_note-PaszkoHow15-27\">[27]<\/a><\/sup> Finally, many modern LIMS tailored to a manufacturing-based industry come pre-configured out of the box with analytical and quality control workflow support tools that can be further optimized to a lab's unique workflow.<sup id=\"rdp-ebb-cite_ref-IngallsHowAdv20_28-0\" class=\"reference\"><a href=\"#cite_note-IngallsHowAdv20-28\">[28]<\/a><\/sup>\n<\/p><p>However, the LIMS is not the sole information management solution for manufacturers and the laboratories they use; they may also use a software-based <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_management_system\" title=\"Quality management system\" class=\"wiki-link\" data-key=\"dfecf3cd6f18d4a5e9ac49ca360b447d\">quality management system<\/a> (QMS) or <a href=\"https:\/\/www.limswiki.org\/index.php\/Manufacturing_execution_system\" title=\"Manufacturing execution system\" class=\"wiki-link\" data-key=\"02e93282eda3e4708b1789cb47519917\">manufacturing execution system<\/a> (MES) in their operations. (We'll briefly discuss them more in section 3.2.1.) Software-based information management solutions are being marketed to manufacturing-based labs in ways other than as a LIMS. Some vendors have taken to marketing the somewhat related <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_execution_system\" title=\"Laboratory execution system\" class=\"wiki-link\" data-key=\"774bdcab852f4d09565f0486bfafc26a\">laboratory execution system<\/a> (LES), which tends to focus more on laboratory test method execution at the process level while integrating other R&D functionalities found in, for example, <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_laboratory_notebook\" title=\"Electronic laboratory notebook\" class=\"wiki-link\" data-key=\"a9fbbd5e0807980106763fab31f1e72f\">electronic laboratory notebooks<\/a> (ELNs).<sup id=\"rdp-ebb-cite_ref-iVentionLES_29-0\" class=\"reference\"><a href=\"#cite_note-iVentionLES-29\">[29]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LVSHowLIMS20_30-0\" class=\"reference\"><a href=\"#cite_note-LVSHowLIMS20-30\">[30]<\/a><\/sup> Some software vendors incorporate <a href=\"https:\/\/www.limswiki.org\/index.php\/Artificial_intelligence\" title=\"Artificial intelligence\" class=\"wiki-link\" data-key=\"0c45a597361ca47e1cd8112af676276e\">artificial intelligence<\/a> (AI) and <a href=\"https:\/\/www.limswiki.org\/index.php\/Machine_learning\" title=\"Machine learning\" class=\"wiki-link\" data-key=\"79aab39cfa124c958cd1dbcab3dde122\">machine learning<\/a> (ML) mechanisms into their LIMS-like manufacturing labortatory software and package it differently, e.g., as a \"materials informatics platform\"<sup id=\"rdp-ebb-cite_ref-MZMaterials_31-0\" class=\"reference\"><a href=\"#cite_note-MZMaterials-31\">[31]<\/a><\/sup> or an \"applied sciences platform.\"<sup id=\"rdp-ebb-cite_ref-ACIMakeBetter_32-0\" class=\"reference\"><a href=\"#cite_note-ACIMakeBetter-32\">[32]<\/a><\/sup> This platform approach to software is arguably growing as a trend<sup id=\"rdp-ebb-cite_ref-ZhuProducts16_33-0\" class=\"reference\"><a href=\"#cite_note-ZhuProducts16-33\">[33]<\/a><\/sup>, so these laboratory informatics platforms may have utility in specific manufacturing-based labs. In comparison, some LIMS may or may not address these and other requirements; this functionality will be discussed further in the next subsection.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.1.2_Features_and_functions\">3.1.2 Features and functions<\/span><\/h4>\n<p>Given the above, it's clear LIMS adoption and use is important to the continued success of manufacturing-based labs. However, in most cases, a generic LIMS won't do; it's imperative the lab find a solution that meets all or most of its workflow requirements. This more often than not requires a configurable solution that enables trained users to quickly make the changes they need, if those changes make sense within the overall data structure of the LIMS. It also requires a solution that has been thoughtfully developed and continues to be carefully maintained to address the ever-shifting standard- and regulation-based requirements of the manufacturing-based laboratory. The following examines both the base features and specialty requirements of a manufacturing LIMS.\n<\/p><p><b>3.1.2.1 Base features<\/b>\n<\/p><p>What follows is a list of system functionality important to most any manufacturing-based laboratory, with a majority of that functionality found in many vendor software solutions.<sup id=\"rdp-ebb-cite_ref-SmithInteg19_20-3\" class=\"reference\"><a href=\"#cite_note-SmithInteg19-20\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ApteIsYour20_26-1\" class=\"reference\"><a href=\"#cite_note-ApteIsYour20-26\">[26]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-McDermottHowDig18_24-1\" class=\"reference\"><a href=\"#cite_note-McDermottHowDig18-24\">[24]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-IngallsHowAdv20_28-1\" class=\"reference\"><a href=\"#cite_note-IngallsHowAdv20-28\">[28]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-iVentionLES_29-1\" class=\"reference\"><a href=\"#cite_note-iVentionLES-29\">[29]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-TNMWhatAre22_34-0\" class=\"reference\"><a href=\"#cite_note-TNMWhatAre22-34\">[34]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ISRoleOfLab_35-0\" class=\"reference\"><a href=\"#cite_note-ISRoleOfLab-35\">[35]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-StarlimsManuf21_36-0\" class=\"reference\"><a href=\"#cite_note-StarlimsManuf21-36\">[36]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GoldbergBeni19_37-0\" class=\"reference\"><a href=\"#cite_note-GoldbergBeni19-37\">[37]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RoshaLIMS05_38-0\" class=\"reference\"><a href=\"#cite_note-RoshaLIMS05-38\">[38]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ThurstonAchiev13_39-0\" class=\"reference\"><a href=\"#cite_note-ThurstonAchiev13-39\">[39]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RussomImplem12_40-0\" class=\"reference\"><a href=\"#cite_note-RussomImplem12-40\">[40]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FamiliLab22_41-0\" class=\"reference\"><a href=\"#cite_note-FamiliLab22-41\">[41]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GuoCloud20_42-0\" class=\"reference\"><a href=\"#cite_note-GuoCloud20-42\">[42]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-StarlimsFood22_43-0\" class=\"reference\"><a href=\"#cite_note-StarlimsFood22-43\">[43]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-:0_44-0\" class=\"reference\"><a href=\"#cite_note-:0-44\">[44]<\/a><\/sup>\n<\/p><p><i><b>Test, sample and result management<\/b><\/i>\n<\/p>\n<ul><li>Sample log-in and management, with support for unique IDs<\/li>\n<li>Sample batching<\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Barcode\" title=\"Barcode\" class=\"wiki-link\" data-key=\"e0952b5b262392be0995237aec36d355\">Barcode<\/a> and RFID support<\/li>\n<li>End-to-end sample and inventory tracking<\/li>\n<li>Pre-defined and configurable industry-specific test and method management, including for bacteria (i.e., microbiology), heavy metals (i.e., chemistry), drug residues (i.e., pharmaceutical chemistry), and other substances<\/li>\n<li>Pre-defined and configurable industry-specific workflows<\/li>\n<li>Configurable screens and data fields<\/li>\n<li>Specification management<\/li>\n<li>Test, sampling, instrument, etc. scheduling and assignment<\/li>\n<li>Test requesting<\/li>\n<li>Data import and export<\/li>\n<li>Robust query tools<\/li>\n<li>Analytical tools, including <a href=\"https:\/\/www.limswiki.org\/index.php\/Data_visualization\" title=\"Data visualization\" class=\"wiki-link\" data-key=\"4a3b86cba74bc7bb7471aa3fc2fcccc3\">data visualization<\/a>, statistical analysis, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Data_mining\" title=\"Data mining\" class=\"wiki-link\" data-key=\"be09d3680fe1608addedf6f62692ee47\">data mining<\/a> tools<\/li>\n<li>Document and image management<\/li>\n<li>Version control<\/li>\n<li>Project management<\/li>\n<li>Method and protocol management<\/li>\n<li>Investigation management<\/li>\n<li>Facility and sampling site management<\/li>\n<li>Storage management and monitoring<\/li>\n<li>Contractor lab and outsourcing support<\/li><\/ul>\n<p><i><b>Quality, security, and compliance<\/b><\/i>\n<\/p>\n<ul><li><a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_assurance\" title=\"Quality assurance\" class=\"wiki-link\" data-key=\"2ede4490f0ea707b14456f44439c0984\">Quality assurance<\/a> \/ <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_control\" title=\"Quality control\" class=\"wiki-link\" data-key=\"1e0e0c2eb3e45aff02f5d61799821f0f\">quality control<\/a> mechanisms<\/li>\n<li>Mechanisms for compliance with ISO\/IEC 17025 and HACCP, including support for critical control point (CCP) specifications and limits<\/li>\n<li>Result, method, protocol, batch, and material validation, review, and release<\/li>\n<li>Data validation<\/li>\n<li>Trend and control charting for statistical analysis and measurement of uncertainty<\/li>\n<li>User qualification, performance, and training management<\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Audit_trail\" title=\"Audit trail\" class=\"wiki-link\" data-key=\"96a617b543c5b2f26617288ba923c0f0\">Audit trails<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Chain_of_custody\" title=\"Chain of custody\" class=\"wiki-link\" data-key=\"6ba04fe2bb1c8375e133455821aa3894\">chain of custody<\/a> support<\/li>\n<li>Configurable and granular role-based security<\/li>\n<li>Configurable system access and use (i.e., authentication requirements, account usage rules, account locking, etc.)<\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_signature\" title=\"Electronic signature\" class=\"wiki-link\" data-key=\"dd6997760552a80c6babaf1174c092f4\">Electronic signature<\/a> support<\/li>\n<li>Data <a href=\"https:\/\/www.limswiki.org\/index.php\/Encryption\" title=\"Encryption\" class=\"wiki-link\" data-key=\"86a503652ed5cc9d8e2b0252a480b5e1\">encryption<\/a> and secure communication protocols<\/li>\n<li>Archiving and <a href=\"https:\/\/www.limswiki.org\/index.php\/Data_retention\" title=\"Data retention\" class=\"wiki-link\" data-key=\"d77533b92d003d39cee958a82b62391a\">retention<\/a> of data and information<\/li>\n<li>Configurable data <a href=\"https:\/\/www.limswiki.org\/index.php\/Backup\" title=\"Backup\" class=\"wiki-link\" data-key=\"e12548e6bf5f28bfee99099fe8662dde\">backups<\/a><\/li>\n<li>Status updates and alerts<\/li>\n<li>Environmental monitoring support<\/li>\n<li>Incident and non-conformance notification, tracking, and management<\/li><\/ul>\n<p><i><b>Operations management and reporting<\/b><\/i>\n<\/p>\n<ul><li>Configurable dashboards for monitoring, by product, process, facility, etc.<\/li>\n<li>Customizable rich-text reporting, with multiple supported output formats<\/li>\n<li>Custom and industry-specific reporting, including certificates of analysis (CoAs)<\/li>\n<li>Industry-compliant labeling<\/li>\n<li>Email integration<\/li>\n<li>Instrument interfacing and data management<\/li>\n<li>Third-party software interfacing (e.g., LES, scientific data management system [SDMS], other database)<\/li>\n<li>Data import, export, and archiving<\/li>\n<li>Instrument calibration and maintenance tracking<\/li>\n<li>Inventory and material management<\/li>\n<li>Supplier\/vendor\/customer management<\/li>\n<li>Integrated (or online) system help<\/li><\/ul>\n<p><b>3.1.2.2 Specialty features<\/b>\nAs noted previously, some software vendors are addressing manufacturing-based laboratories' needs beyond basic organizational LIMS functionality with their specialty solutions. A standard LIMS tailored for various manufacturing industries may already contribute to some of these wider organizational functions, as well as more advanced laboratory workflow requirements, but many may not, or may vary in what additional functionality they provide. In that regard, a LIMS vendor may also include specialized functionality that goes beyond the basic and addresses specialized activities of the manufacturer and its laboratories<sup id=\"rdp-ebb-cite_ref-iVentionLES_29-2\" class=\"reference\"><a href=\"#cite_note-iVentionLES-29\">[29]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-StarlimsManuf21_36-1\" class=\"reference\"><a href=\"#cite_note-StarlimsManuf21-36\">[36]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RoshaLIMS05_38-1\" class=\"reference\"><a href=\"#cite_note-RoshaLIMS05-38\">[38]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RussomImplem12_40-1\" class=\"reference\"><a href=\"#cite_note-RussomImplem12-40\">[40]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FamiliLab22_41-1\" class=\"reference\"><a href=\"#cite_note-FamiliLab22-41\">[41]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-StarlimsFood22_43-1\" class=\"reference\"><a href=\"#cite_note-StarlimsFood22-43\">[43]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Douglas_45-0\" class=\"reference\"><a href=\"#cite_note-Douglas-45\">[45]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-46\" class=\"reference\"><a href=\"#cite_note-46\">[46]<\/a><\/sup>:\n<\/p>\n<ul><li><b>Manage stability studies<\/b>: From the pharmaceutical industry to the food and beverage industry, stability studies are an important specialty activity. These studies require careful statistical analysis, predictive modeling, sensory analysis, quantitative descriptive testing, discrimination testing, microbiology testing, and more. This translates to a need for a wide variety of analytical and visualization tools, as well as LIMS support for a wide variety of test methods and limits. A robust LIMS should have these abilities, but not all do.<\/li>\n<li><b>Manage recipes and formulations, as well as master and batch production records<\/b>: This functionality is more in the domain of the LES or manufacturing execution system (MES). However, a few LIMS vendors may extend their LIMS to provide these features. Given the Hazard Analysis and Critical Control Points (HACCP) rules of the food and beverage industry, as well as other master and batch record requirements for other regulated industries like the pharmaceutical industry, manufacturing labs testing batches and manufacturing materials may appreciate support in this regard.<\/li>\n<li><b>Support molecular biology workflows<\/b>: Molecular biology is an important tool in improving foods and beverages, ensuring the safety of pharmaceuticals, and meeting cannabis product testing requirements of state governments. However, not all LIMS are ideally equipped to handle related workflow aspects such as nucleic acid extraction, protein and cell isolation, and genotyping. A lab using such techniques may have to do extra due diligence in finding a manufacturing LIMS that also supports these workflow tasks.<\/li>\n<li><b>Take advantage of ELN functionality<\/b>: Given the level of R&D to be found in manufacturing facilities, the ELN is a familiar companion to other informatics systems. A few LIMS vendors may have a built-in ELN with their LIMS or offer an ELN that comes readily integrated with the LIMS. Some elements of ELN functionality may even be found in a few solutions. At a minimum\u2014and nodded to in the base functionality above\u2014the LIMS should support ELN functionality through its ability to effectively connect to a third-party ELN.<\/li>\n<li><b>Develop regulatory-driven safety plans<\/b>: The HACCP quality control method is recommended or required for food and testing labs and is an influence on ISO\/IEC 17025, which applies to many other manufacturing labs. Some LIMS vendors have recognized this and integrated support for building HACCP steps into laboratory workflows. In some cases this may be as sophisticated as allowing the user to diagram HACCP in their lab or facility as a visualization tool.<\/li>\n<li><b>Generate schedules for environmental monitoring\/testing in the facility\/lab<\/b>: While a LIMS can help assign and schedule a variety of laboratory tasks, broader organizational goals of testing the production environment on a scheduled, reportable basis may not be so straightforward, particularly without facility and sampling site management functionality that allows for highlighting specific test points in the facility. Even offsite or randomized testing may not be fully supported by a generic LIMS, requiring a LIMS flexible enough to compensate for the need for broader scheduled and randomized testing and retesting.<\/li>\n<li><b>Improve reaction time to non-conformances<\/b>: Many LIMS will have some basic form of non-conformance and incident management tools, but the robustness and extensibility of that functionality may be lacking. Can it send an SMS or email to the appropriate supplier in real-time when a pre-defined set of circumstances concerning that supplier's ingredients occurs? Can it re-prioritize or pause other related activities that are scheduled due to the identified non-conformance or incident? This is a useful area of functionality for the potential LIMS buyer to confirm with a vendor.<\/li>\n<li><b>Improve audit readiness and reporting<\/b>: A LIMS worth its weight will have a robust audit trail, to be sure. But can your LIMS help you audit your suppliers? Can it capture internal audit data on-demand and directly from the facility floor via mobile-friendly forms? Can HACCP- and audit-related data be flagged as such to make retrieval more efficient for audit purposes? These and other considerations may be important to a manufacturing facility, and not all LIMS for manufacturers can provide that functionality.<\/li><\/ul>\n<h4><span class=\"mw-headline\" id=\"3.1.3_Cybersecurity_considerations\">3.1.3 Cybersecurity considerations<\/span><\/h4>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Measuring_cybersecurity.png\" class=\"image wiki-link\" data-key=\"faa87e8246fb8997d91b59e244fb5e2d\"><img alt=\"Measuring cybersecurity.png\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/5e\/Measuring_cybersecurity.png\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>From law firms<sup id=\"rdp-ebb-cite_ref-SobowaleLaw17_47-0\" class=\"reference\"><a href=\"#cite_note-SobowaleLaw17-47\">[47]<\/a><\/sup> to automotive manufacturers<sup id=\"rdp-ebb-cite_ref-WatneyAddress17_48-0\" class=\"reference\"><a href=\"#cite_note-WatneyAddress17-48\">[48]<\/a><\/sup>, the need to address cybersecurity is increasingly apparent. In 2018, the Center for Strategic & International Studies estimated that cybercrime causes close to $600 billion in damages to the global economy every year<sup id=\"rdp-ebb-cite_ref-LewisEcon18_49-0\" class=\"reference\"><a href=\"#cite_note-LewisEcon18-49\">[49]<\/a><\/sup>, though due to underreporting of crimes, that number may be much higher. That number also likely doesn't take into account lost business, fines, litigation, and intangible losses<sup id=\"rdp-ebb-cite_ref-SBDCC_BlogCost17_50-0\" class=\"reference\"><a href=\"#cite_note-SBDCC_BlogCost17-50\">[50]<\/a><\/sup> In the end, businesses of all sizes average about $200,000 in losses due to a cybersecurity incident<sup id=\"rdp-ebb-cite_ref-HiscoxHiscox19.22_51-0\" class=\"reference\"><a href=\"#cite_note-HiscoxHiscox19.22-51\">[51]<\/a><\/sup>, and nearly 60 percent of small and midsize businesses go bankrupt within six months because of it.<sup id=\"rdp-ebb-cite_ref-Galvin60_18_52-0\" class=\"reference\"><a href=\"#cite_note-Galvin60_18-52\">[52]<\/a><\/sup>\n<\/p><p>Manufacturing-based laboratories are no exception, regardless of business size. Even tiny labs whose primary digital footprint is a WordPress website advertising their lab are at risk, as hackers could still spread malware, steal user data, add the website to a bot network, hack the site for the learning experience, or even hack it just for fun.<sup id=\"rdp-ebb-cite_ref-GrimaTop19_53-0\" class=\"reference\"><a href=\"#cite_note-GrimaTop19-53\">[53]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MoenWhatHack16_54-0\" class=\"reference\"><a href=\"#cite_note-MoenWhatHack16-54\">[54]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-TalalevWebsite19_55-0\" class=\"reference\"><a href=\"#cite_note-TalalevWebsite19-55\">[55]<\/a><\/sup> Even more importantly are those labs performing digital data management tasks that handle sensitive proprietary manufacturer data, requiring additional cybersecurity considerations.\n<\/p><p>A manufacturer and its associated laboratories can integrate cybersecurity thinking into its laboratory informatics product selection in several ways. First, the organization should have a cybersecurity plan in place, or if not, it should be on the radar. This is a good resource to tap into in regards to deciding what cybersecurity considerations should be made for the software. Can the software help your organization meet your cybersecurity goals? What regulatory requirements for your lab are or are not covered by the software?<sup id=\"rdp-ebb-cite_ref-DouglasComp20_11-1\" class=\"reference\"><a href=\"#cite_note-DouglasComp20-11\">[11]<\/a><\/sup> Another tool to consider\u2014which may have been used in any prior cybersecurity planning efforts\u2014is a cybersecurity framework. Many, but not all, cybersecurity frameworks include a catalog of security controls. Each control is \"a safeguard or countermeasure prescribed for an information system or an organization designed to protect the confidentiality, integrity, and availability of its information and to meet a set of defined security requirements.\"<sup id=\"rdp-ebb-cite_ref-NISTSecurity19_56-0\" class=\"reference\"><a href=\"#cite_note-NISTSecurity19-56\">[56]<\/a><\/sup> These controls give the implementing organization a concrete set of configurable goals to apply to their overall cybersecurity strategy. Other frameworks may be less oriented to security controls and more program-based or risk-based. Choosing the best frameworks will likely depend on multiple factors, including the organization's industry type, the amount of technical expertise within the organization, the budget, the organizational goals, the amount of buy-in from key organizational stakeholders, and those stakeholders' preferred approach.<sup id=\"rdp-ebb-cite_ref-DouglasComp20_11-2\" class=\"reference\"><a href=\"#cite_note-DouglasComp20-11\">[11]<\/a><\/sup>\n<\/p><p>Finally, having an organizational cybersecurity plan that incorporates one or more cybersecurity frameworks gives the laboratory ample opportunity to apply stated goals and chosen security controls to the evaluation and selection process for its informatics software. In particular, a user requirements specification (URS) that incorporates cybersecurity considerations will certainly help a laboratory with meeting regulatory requirements while also protecting its data systems. A USR that is pre-built with cybersecurity controls in mind\u2014such as <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMSpec_2022_R2\" title=\"Book:LIMSpec 2022 R2\" class=\"wiki-link\" data-key=\"df2e12ebefc2379e95f3f1956aac4400\">LIMSpec<\/a>, discussed later\u2014makes the evaluation process even easier.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.1.4_Regulatory_compliance_considerations\">3.1.4 Regulatory compliance considerations<\/span><\/h4>\n<p>Without a doubt, it's vital that manufacturing-based laboratories operate within the bounds of a regulatory atmosphere, not only to better ensure the best consumer satisfaction outcomes but also to ensure the quality of analytical results, the safety of end users, and the promise of maintaining traceability across the manufacturing and distribution chain. Maintaining regulatory compliance requires deliberate approaches to developing and enforcing processes and procedures, quality training, consistent communication, and knowledgeable personnel. It also requires a top-down appreciation and commitment to a culture of quality. From ISO\/TS 22002-1:2009 <i>Prerequisite programmes on food safety \u2014 Part 1: Food manufacturing<\/i> and ISO 10993-1:2018 <i>Biological evaluation of medical devices \u2014 Part 1: Evaluation and testing within a risk management process<\/i> to 21 CFR Part 175 and 176 (concerning the materials used to package food) and current good manufacturing practice (cGMP), laboratories have much to consider in regards to what standards and regulations impact them.\n<\/p><p>That said, consider approaching the question of regulatory compliance from the standpoint of adopting standards. Consider first that the risks and consequences of performing a task poorly drives regulation and, more preferably<sup id=\"rdp-ebb-cite_ref-CiocoiuTheRole10_57-0\" class=\"reference\"><a href=\"#cite_note-CiocoiuTheRole10-57\">[57]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-JPMorganData18_58-0\" class=\"reference\"><a href=\"#cite_note-JPMorganData18-58\">[58]<\/a><\/sup>, standardization, which in turn moves the \"goalposts\" of quality and security among organizations. In the case of regulations, those organization that get caught not conforming to the necessary regulations tend to suffer negative consequences, providing some incentive for them to improve organizational processes and procedures. \n<\/p><p>One of the downsides of regulations is that they can at times be \"imprecise\" or \"disconnected\"<sup id=\"rdp-ebb-cite_ref-JPMorganData18_58-1\" class=\"reference\"><a href=\"#cite_note-JPMorganData18-58\">[58]<\/a><\/sup> from what actually occurs within the organization and its information systems. Rather than focusing heavily on regulatory conformance, well-designed standards may, when adopted, provide a clearer path of opportunity for organizations to improve their operational culture and outcomes, particularly since standards are usually developed with a broader consensus of interested individuals with expertise in a given field.<sup id=\"rdp-ebb-cite_ref-CiocoiuTheRole10_57-1\" class=\"reference\"><a href=\"#cite_note-CiocoiuTheRole10-57\">[57]<\/a><\/sup> In turn, the organizations that adopt well-designed standards likely have a better chance of conforming to the regulations they must, and they'll likely have more interest in maintaining and improving the goalposts of quality and security in the lab.\n<\/p><p>Additionally, reputable software developers of laboratory informatics software will not only adopt their own industry standards for software development but also understand the standards and regulations that affect manufacturing-based laboratories. In turn, the developed software should meet regulations and standards, help the laboratory comply with its regulations and standards, and be of reliably good quality. \n<\/p><p>If you're a potential buyer of a laboratory informatics solution, it may be that you know a bit about your laboratory's workflow and a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed about all the regulations and standards that affect your lab. Turning to a URS such as LIMSpec\u2014which was developed around laboratory regulations and standards\u2014and reviewing the various statements contained within may be necessary to help further inform you. Additionally, as you investigate various informatics options, you can then use the requirements in the URS as a base for your laboratory's own requirements list. Using the categories and their subdivisions, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by the base URS. As you review the various options available to you and narrow down your search, your own list of requirements can be used as both as a personal checklist and as a requirements list you hand over to the vendor you query. And since your URS is based off the standards and regulations affecting your lab, you can feel more confident in your acquisition and its integration into your laboratory workflow.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.1.5_System_flexibility\">3.1.5 System flexibility<\/span><\/h4>\n<p>Before selecting a solution, your laboratory should also have internal discussions about how diversified its offered services are, as well as what the future may bring to the lab. If, for example, your lab is currently configured for microbiological testing, does your existing laboratory informatics system\u2014or the ones you may be considering\u2014have the flexibility to add other types of testing, protocols, and workflows? Will you be doing the footwork to add them, or will the vendor of your system support you in that effort? If you're a start-up, will your lab be focusing solely on a specific type of testing and expand into other types of analytical work later, or will your test menu need to be much broader right from the start? In most of these cases, you'll desire a LIMS that is flexible enough to allow for not only running the specific tests you need now, but also sufficiently expandable for any future testing services your lab may conduct in the mid- and long-term. Having the ability to create and customize <a href=\"https:\/\/www.limswiki.org\/index.php\/Sample_(material)\" title=\"Sample (material)\" class=\"wiki-link\" data-key=\"7f8cd41a077a88d02370c02a3ba3d9d6\">sample<\/a> registration screens, test protocols, labels, reports, specification limit sets, measurement units, and substrates\/matrices while being able to interface with practically most any instrument and software system required will go a long way towards making your expanding test menu and workflows integrates as smoothly as possible.\n<\/p><p>Such a system will typically be marketed as being highly user-configurable, giving labs a relatively painless means to adapt to rapid changes in test volume and type over time. However, once you've internally addressed current and anticipated future growth, your lab will want to learn what explicitly makes any given vendor's system user-configurable. How easy is it to configure the system to new tests? Add custom reports? What knowledge or skills will be required of your lab in order to make the necessary changes, i.e., will your staff require programming skills, or are the administrator and advanced user functions robust enough to make changes without hard-coding? These and other such questions should be fully addressed by the vendor in order to set your mind at ease towards a system's stated flexibility. Ultimately, you want the system to be flexible enough to change with the laboratory\u2014and industry\u2014itself, while minimizing overall costs and reducing the time required to make any necessary modifications.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.1.6_Cost_considerations\">3.1.6 Cost considerations<\/span><\/h4>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Lies-pound-yen-euro-dollar.png\" class=\"image wiki-link\" data-key=\"b4c18a89cdc2846c9d5fd1db6c6bcdcd\"><img alt=\"Lies-pound-yen-euro-dollar.png\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/f\/f4\/Lies-pound-yen-euro-dollar.png\" decoding=\"async\" width=\"300\" height=\"107\" \/><\/a><\/div><p>First, you'll want to be clear on what will be included in the sales agreement. Whether through an estimate or statement of work (SOW), it is important it includes exactly what is expected, being as specific as possible, since this will be the entire contractual obligation for both you the buyer and them the vendor. Note that line items may differ slightly from system to system, according to what features and functions are included by default with each vendor's solution and which, if any, are additional. Also keep in mind that any hourly amount in the the estimate or SOW is usually a best estimate; however, if sufficient attention to detailed requirements has been given, then it should be quite accurate, and in fact the final cost may even be below the quoted cost if you prioritize your own obligations so that the vendor's hours are used sparingly and efficiently. \n<\/p><p>The estimate or SOW should optimally include:\n<\/p>\n<ul><li>licensing or subscription rates;<\/li>\n<li>required core items to meet federal, state, and local regulations;<\/li>\n<li>additional optional items and totals; and<\/li>\n<li>required services (implementation, maintenance and support, optional add-ons).<\/li><\/ul>\n<p>There are two primary ways to price a laboratory informatics solution: a one-time license fee or a subscription rate (<a href=\"https:\/\/www.limswiki.org\/index.php\/Cloud_computing\" title=\"Cloud computing\" class=\"wiki-link\" data-key=\"fcfe5882eaa018d920cedb88398b604f\">cloud-hosted<\/a> SaaS). If you have your own dedicated IT department and staff, you may prefer the former (although many system administrators are just as happy to let it be hosted elsewhere rather than add to their workload). Otherwise, a SaaS subscription may well be the better and more cost-effective way to go (since the primary IT cost is simply internet access). This item will be part of your up-front cost and, in the case of subscription, it will also figure into your first year and ongoing costs; otherwise only associated maintenance, support, and warranty (MSW) will figure in. Typically, your first year's subscription costs will be due at signing. More often, the vendor may require three months or even the first year up front, so be prepared to factor that into up-front costs. However, it still is almost always less expensive at the outset (and over time, if you factor in IT costs and annual MSW) than paying for a license fee.\n<\/p><p>In addition to the two types of software pricing, there are also sub-types. Generally these are based on the number of users (or, in some cases, \"nodes,\" which are simply any entities that access the informatics system, including other systems, instruments, etc.). How these are counted can vary.\n<\/p>\n<ul><li>Named users: This method bases pricing on the actual individual users of the system, even if they only log in sporadically. Users may not use each other's logins (this is a no-no regardless of pricing structure, for good laboratory practice and other regulatory reasons).<\/li>\n<li>Concurrent users: This bases pricing on the maximum number of users who will be logged in at any given time. You can define an unlimited number of named users in the system, each with their own login credentials. However, only the number of concurrent users specified in the license or subscription may be logged in at any one time. For example, you may have 10 staff, but due to work processes, shifts, etc., only up to six might ever be logged in simultaneously. Whereas this would require a named user license for 10, it would only require a concurrent user license for six.<\/li>\n<li>Unlimited users: In the case of very large labs (typically 30 to 50 and up), the license or subscription may simply be a flat fee that allows any number of users.<\/li><\/ul>\n<p>The line items in the estimate or SOW should reflect these nuances, as well as whether the listed costs are monthly or annual (for subscription services), hourly (typically for support and training), or a fixed one-time cost. Additionally, be cautious with fixed costs, as they typically represent one of two possible scenarios:\n<\/p>\n<ol><li>Final fixed cost: In this case, the cost has been figured by the vendor so as to cover their worst-case hourly labor total. If a line item (e.g., an interface) is not \"worst case,\" then you are overpaying.<\/li>\n<li>\"Expandable\" fixed cost: This is as bad as final fixed cost, and maybe even worse because it's almost a case of \"bait-and-switch,\" popping up as a surprise. The initial \"fixed cost\" number is low, and additional hourly services are needed to actually deliver the item. This will have been provided for somewhere in the small print.<\/li><\/ol>\n<p>The bottom line is that everything in a laboratory informatics solution is really either licensing or hourly services. Just be careful if they are portrayed as anything else.\n<\/p><p>It is important to be clear which category each line item falls under when figuring costs: up-front (due upon signing), annual, or ongoing (e.g., SaaS subscription). It is useful to clearly lay out each and compute initial costs, as well as first-year and subsequent years' costs. For example, your initial obligation may be as little as your first year's subscription plus the first 40 hours of services. Different vendors have different policies, however, and you may be required to pay for your first full year's subscription and all services, or some other combination. Normally, though, any instrument interface or other service charges aren't due until they are implemented, which may be a few weeks or even a month down the road. This may depend on your budget, complexity of the SOW, and urgency. Your first year's expenses will include everything, including initial license fees; all setup and training; any interfaces and additional configurations or customization; and first annual MSW. (If this isn't included in the SaaS subscription, then it usually commences on full system delivery). Afterwards, your subscription and MSW will be the only ongoing expenses (included as one in this example), unless you choose to have additional interfaces or other services performed at any time.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-KriegClinical74-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-KriegClinical74_1-0\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-KriegClinical74_1-1\">1.1<\/a><\/sup> <sup><a href=\"#cite_ref-KriegClinical74_1-2\">1.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Krieg, A.F. (1974). \"Chapter 30: Clinical Laboratory Computerization\". In Davidsohn, I.; Henry, J.B.. <i>Clinical Diagnosis by Laboratory Methods<\/i>. W.B. Saunders Company. pp. 1340\u201358. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 0721629229.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+30%3A+Clinical+Laboratory+Computerization&rft.atitle=Clinical+Diagnosis+by+Laboratory+Methods&rft.aulast=Krieg%2C+A.F.&rft.au=Krieg%2C+A.F.&rft.date=1974&rft.pages=pp.%26nbsp%3B1340%E2%80%9358&rft.pub=W.B.+Saunders+Company&rft.isbn=0721629229&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FlynnComputer65-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FlynnComputer65_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Flynn, F.V. (1965). \"Computer-assisted processing of bio-chemical test data\". In Atkins, H.J.B.. <i>Progress in Medical Computing<\/i>. Blackwell Science Ltd. p. 46. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 0632001801.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Computer-assisted+processing+of+bio-chemical+test+data&rft.atitle=Progress+in+Medical+Computing&rft.aulast=Flynn%2C+F.V.&rft.au=Flynn%2C+F.V.&rft.date=1965&rft.pages=p.%26nbsp%3B46&rft.pub=Blackwell+Science+Ltd&rft.isbn=0632001801&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WilliamsTheUse64-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WilliamsTheUse64_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Williams, G.Z. (1964). \"The Use of Data Processing and Automation in Clinical Pathology\". <i>Military Medicine<\/i> <b>129<\/b> (6): 502\u20139. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1093%2Fmilmed%2F129.6.502\" target=\"_blank\">10.1093\/milmed\/129.6.502<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Use+of+Data+Processing+and+Automation+in+Clinical+Pathology&rft.jtitle=Military+Medicine&rft.aulast=Williams%2C+G.Z.&rft.au=Williams%2C+G.Z.&rft.date=1964&rft.volume=129&rft.issue=6&rft.pages=502%E2%80%939&rft_id=info:doi\/10.1093%2Fmilmed%2F129.6.502&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HicksRoutine66-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HicksRoutine66_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Hicks, G.P.; Gieschen, M.M.; Slack, W.V. et al. (1966). \"Routine Use of a Small Digital Computer in the Clinical Laboratory\". <i>JAMA<\/i> <b>196<\/b> (11): 973\u201378. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1001%2Fjama.1966.03100240107021\" target=\"_blank\">10.1001\/jama.1966.03100240107021<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Routine+Use+of+a+Small+Digital+Computer+in+the+Clinical+Laboratory&rft.jtitle=JAMA&rft.aulast=Hicks%2C+G.P.%3B+Gieschen%2C+M.M.%3B+Slack%2C+W.V.+et+al.&rft.au=Hicks%2C+G.P.%3B+Gieschen%2C+M.M.%3B+Slack%2C+W.V.+et+al.&rft.date=1966&rft.volume=196&rft.issue=11&rft.pages=973%E2%80%9378&rft_id=info:doi\/10.1001%2Fjama.1966.03100240107021&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-StraumfjordElectronic67-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-StraumfjordElectronic67_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Straumfjord, J.V.; Spraberry, M.N.; Biggs, H.G.; Noto, T.A. (1967). \"Electronic Data Processing System for Clinical Laboratories: A System Used for All Laboratory Sections\". <i>American Journal of Clinical Pathology<\/i> <b>47<\/b> (5_ts): 661\u201376. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1093%2Fajcp%2F47.5_ts.661\" target=\"_blank\">10.1093\/ajcp\/47.5_ts.661<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Electronic+Data+Processing+System+for+Clinical+Laboratories%3A+A+System+Used+for+All+Laboratory+Sections&rft.jtitle=American+Journal+of+Clinical+Pathology&rft.aulast=Straumfjord%2C+J.V.%3B+Spraberry%2C+M.N.%3B+Biggs%2C+H.G.%3B+Noto%2C+T.A.&rft.au=Straumfjord%2C+J.V.%3B+Spraberry%2C+M.N.%3B+Biggs%2C+H.G.%3B+Noto%2C+T.A.&rft.date=1967&rft.volume=47&rft.issue=5_ts&rft.pages=661%E2%80%9376&rft_id=info:doi\/10.1093%2Fajcp%2F47.5_ts.661&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BallASurvey70-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BallASurvey70_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Ball, M.J. (1970). \"A Survey of Field Experience in Clinical Laboratory Computerization\". <i>Laboratory Medicine<\/i> <b>1<\/b> (11): 25\u201327, 49\u201351. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1093%2Flabmed%2F1.11.25\" target=\"_blank\">10.1093\/labmed\/1.11.25<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=A+Survey+of+Field+Experience+in+Clinical+Laboratory+Computerization&rft.jtitle=Laboratory+Medicine&rft.aulast=Ball%2C+M.J.&rft.au=Ball%2C+M.J.&rft.date=1970&rft.volume=1&rft.issue=11&rft.pages=25%E2%80%9327%2C+49%E2%80%9351&rft_id=info:doi\/10.1093%2Flabmed%2F1.11.25&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JonesInformatics14-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-JonesInformatics14_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Jones, R.G.; Johnson, O.A.; Batstone, G. (2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4204239\" target=\"_blank\">\"Informatics and the Clinical Laboratory\"<\/a>. <i>The Clinical Biochemist Reviews<\/i> <b>35<\/b> (3): 177\u201392. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4204239\/\" target=\"_blank\">PMC4204239<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25336763\" target=\"_blank\">25336763<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4204239\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4204239<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Informatics+and+the+Clinical+Laboratory&rft.jtitle=The+Clinical+Biochemist+Reviews&rft.aulast=Jones%2C+R.G.%3B+Johnson%2C+O.A.%3B+Batstone%2C+G.&rft.au=Jones%2C+R.G.%3B+Johnson%2C+O.A.%3B+Batstone%2C+G.&rft.date=2014&rft.volume=35&rft.issue=3&rft.pages=177%E2%80%9392&rft_id=info:pmc\/PMC4204239&rft_id=info:pmid\/25336763&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC4204239&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BurtonNHS18-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BurtonNHS18_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Burton, R. (19 July 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/towardsdatascience.com\/nhs-laboratories-need-data-science-c93f7983302c\" target=\"_blank\">\"NHS Laboratories Need Data Science\"<\/a>. <i>Towards Data Science<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/towardsdatascience.com\/nhs-laboratories-need-data-science-c93f7983302c\" target=\"_blank\">https:\/\/towardsdatascience.com\/nhs-laboratories-need-data-science-c93f7983302c<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=NHS+Laboratories+Need+Data+Science&rft.atitle=Towards+Data+Science&rft.aulast=Burton%2C+R.&rft.au=Burton%2C+R.&rft.date=19+July+2018&rft_id=https%3A%2F%2Ftowardsdatascience.com%2Fnhs-laboratories-need-data-science-c93f7983302c&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CuffAugment18-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CuffAugment18_9-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Cuff, J. (18 June 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nextplatform.com\/2018\/06\/19\/augmenting-pathology-labs-with-big-data-and-machine-learning\/\" target=\"_blank\">\"Augmenting Pathology Labs with Big Data and Machine Learning\"<\/a>. <i>The Next Platform<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.nextplatform.com\/2018\/06\/19\/augmenting-pathology-labs-with-big-data-and-machine-learning\/\" target=\"_blank\">https:\/\/www.nextplatform.com\/2018\/06\/19\/augmenting-pathology-labs-with-big-data-and-machine-learning\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Augmenting+Pathology+Labs+with+Big+Data+and+Machine+Learning&rft.atitle=The+Next+Platform&rft.aulast=Cuff%2C+J.&rft.au=Cuff%2C+J.&rft.date=18+June+2018&rft_id=https%3A%2F%2Fwww.nextplatform.com%2F2018%2F06%2F19%2Faugmenting-pathology-labs-with-big-data-and-machine-learning%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-IzrailevskyCloud18-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-IzrailevskyCloud18_10-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Izrailevsky, Y.; Bell, C. (2018). \"Cloud Reliability\". <i>IEEE Cloud Computing<\/i> <b>5<\/b> (3): 39\u201344. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1109%2FMCC.2018.032591615\" target=\"_blank\">10.1109\/MCC.2018.032591615<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Cloud+Reliability&rft.jtitle=IEEE+Cloud+Computing&rft.aulast=Izrailevsky%2C+Y.%3B+Bell%2C+C.&rft.au=Izrailevsky%2C+Y.%3B+Bell%2C+C.&rft.date=2018&rft.volume=5&rft.issue=3&rft.pages=39%E2%80%9344&rft_id=info:doi\/10.1109%2FMCC.2018.032591615&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DouglasComp20-11\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-DouglasComp20_11-0\">11.0<\/a><\/sup> <sup><a href=\"#cite_ref-DouglasComp20_11-1\">11.1<\/a><\/sup> <sup><a href=\"#cite_ref-DouglasComp20_11-2\">11.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Douglas, S.E. (July 2020). \"<a href=\"https:\/\/www.limswiki.org\/index.php\/LII:Comprehensive_Guide_to_Developing_and_Implementing_a_Cybersecurity_Plan\" title=\"LII:Comprehensive Guide to Developing and Implementing a Cybersecurity Plan\" class=\"wiki-link\" data-key=\"fce1737a2e9697fc03e956327817f8ea\"><i>Comprehensive Guide to Developing and Implementing a Cybersecurity Plan<\/i><\/a>\". <i>LIMSwiki<\/i>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=%5B%5BLII%3AComprehensive+Guide+to+Developing+and+Implementing+a+Cybersecurity+Plan%7C%27%27Comprehensive+Guide+to+Developing+and+Implementing+a+Cybersecurity+Plan%27%27%5D%5D&rft.atitle=LIMSwiki&rft.aulast=Douglas%2C+S.E.&rft.au=Douglas%2C+S.E.&rft.date=July+2020&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HintonLIMSIn95-12\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HintonLIMSIn95_12-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Hinton, Mary (1 December 1995). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/1381141X9580027Z\" target=\"_blank\">\"LIMS in the manufacturing environment\"<\/a> (in en). <i>Laboratory Automation & Information Management<\/i> <b>31<\/b> (2): 109\u2013113. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2F1381-141X%2895%2980027-Z\" target=\"_blank\">10.1016\/1381-141X(95)80027-Z<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" data-key=\"a5dec3e4d005e654c29ad167ab53f53a\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/issn\/1381-141X\" target=\"_blank\">1381-141X<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/1381141X9580027Z\" target=\"_blank\">https:\/\/www.sciencedirect.com\/science\/article\/pii\/1381141X9580027Z<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=LIMS+in+the+manufacturing+environment&rft.jtitle=Laboratory+Automation+%26+Information+Management&rft.aulast=Hinton&rft.aufirst=Mary&rft.au=Hinton%2C%26%2332%3BMary&rft.date=1+December+1995&rft.volume=31&rft.issue=2&rft.pages=109%E2%80%93113&rft_id=info:doi\/10.1016%2F1381-141X%2895%2980027-Z&rft.issn=1381-141X&rft_id=https%3A%2F%2Fwww.sciencedirect.com%2Fscience%2Farticle%2Fpii%2F1381141X9580027Z&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HintonLIMS96-13\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HintonLIMS96_13-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Hinton, Mary D.; Hinton, Phillip R. (1996). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hindawi.com\/journals\/jamc\/1996\/723762\/abs\/\" target=\"_blank\">\"LIMS and chromatographic data acquisition in the manufacturing environment\"<\/a> (in en). <i>Journal of Automatic Chemistry<\/i> <b>18<\/b> (5): 169\u2013174. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1155%2FS1463924696000181\" target=\"_blank\">10.1155\/S1463924696000181<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" data-key=\"a5dec3e4d005e654c29ad167ab53f53a\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/issn\/0142-0453\" target=\"_blank\">0142-0453<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2548082\/\" target=\"_blank\">PMC2548082<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/18925032\" target=\"_blank\">18925032<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.hindawi.com\/journals\/jamc\/1996\/723762\/abs\/\" target=\"_blank\">http:\/\/www.hindawi.com\/journals\/jamc\/1996\/723762\/abs\/<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=LIMS+and+chromatographic+data+acquisition+in+the+manufacturing+environment&rft.jtitle=Journal+of+Automatic+Chemistry&rft.aulast=Hinton&rft.aufirst=Mary+D.&rft.au=Hinton%2C%26%2332%3BMary+D.&rft.au=Hinton%2C%26%2332%3BPhillip+R.&rft.date=1996&rft.volume=18&rft.issue=5&rft.pages=169%E2%80%93174&rft_id=info:doi\/10.1155%2FS1463924696000181&rft.issn=0142-0453&rft_id=info:pmc\/PMC2548082&rft_id=info:pmid\/18925032&rft_id=http%3A%2F%2Fwww.hindawi.com%2Fjournals%2Fjamc%2F1996%2F723762%2Fabs%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-14\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-14\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">\u00c7a\u011f\u0131nd\u0131, \u00d6zlem; \u00d6tle\u015f, Semih (1 December 2004). \"Importance of laboratory information management systems (LIMS) software for food processing factories\" (in en). <i>Journal of Food Engineering<\/i> <b>65<\/b> (4): 565\u2013568. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.jfoodeng.2004.02.021\" target=\"_blank\">10.1016\/j.jfoodeng.2004.02.021<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Importance+of+laboratory+information+management+systems+%28LIMS%29+software+for+food+processing+factories&rft.jtitle=Journal+of+Food+Engineering&rft.aulast=%C3%87a%C4%9F%C4%B1nd%C4%B1&rft.aufirst=%C3%96zlem&rft.au=%C3%87a%C4%9F%C4%B1nd%C4%B1%2C%26%2332%3B%C3%96zlem&rft.au=%C3%96tle%C5%9F%2C%26%2332%3BSemih&rft.date=1+December+2004&rft.volume=65&rft.issue=4&rft.pages=565%E2%80%93568&rft_id=info:doi\/10.1016%2Fj.jfoodeng.2004.02.021&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AstrixLIMS21-15\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AstrixLIMS21_15-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/astrixinc.com\/wp-content\/uploads\/2021\/03\/Astrix-2020-LIMS-Market-Research-Report.pdf\" target=\"_blank\">\"2020 LIMS Market Research Survey Report\"<\/a> (PDT). Astrix Technology, LLC. March 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/astrixinc.com\/wp-content\/uploads\/2021\/03\/Astrix-2020-LIMS-Market-Research-Report.pdf\" target=\"_blank\">https:\/\/astrixinc.com\/wp-content\/uploads\/2021\/03\/Astrix-2020-LIMS-Market-Research-Report.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=2020+LIMS+Market+Research+Survey+Report&rft.atitle=&rft.date=March+2021&rft.pub=Astrix+Technology%2C+LLC&rft_id=https%3A%2F%2Fastrixinc.com%2Fwp-content%2Fuploads%2F2021%2F03%2FAstrix-2020-LIMS-Market-Research-Report.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PTOLIMS22-16\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PTOLIMS22_16-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pharma Tech Outlook (2 September 2022). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pharmatechoutlook.com\/news\/lims-add-competitive-advantage-to-cdmos-nwid-2386.html\" target=\"_blank\">\"LIMS Add Competitive Advantage to CDMOs\"<\/a>. <i>Pharma Tech Outlook<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.pharmatechoutlook.com\/news\/lims-add-competitive-advantage-to-cdmos-nwid-2386.html\" target=\"_blank\">https:\/\/www.pharmatechoutlook.com\/news\/lims-add-competitive-advantage-to-cdmos-nwid-2386.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=LIMS+Add+Competitive+Advantage+to+CDMOs&rft.atitle=Pharma+Tech+Outlook&rft.aulast=Pharma+Tech+Outlook&rft.au=Pharma+Tech+Outlook&rft.date=2+September+2022&rft_id=https%3A%2F%2Fwww.pharmatechoutlook.com%2Fnews%2Flims-add-competitive-advantage-to-cdmos-nwid-2386.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AbazeriHowDoes22-17\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AbazeriHowDoes22_17-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Abazeri, L. (10 November 2022). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blogs.sw.siemens.com\/consumer-products-retail\/2022\/11\/10\/how-does-using-an-integrated-laboratory-information-management-system-lims-improve-food-beverage-manufacturing-quality\/\" target=\"_blank\">\"How does using an integrated laboratory information management system (LIMS) improve food & beverage manufacturing quality?\"<\/a>. Siemens<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blogs.sw.siemens.com\/consumer-products-retail\/2022\/11\/10\/how-does-using-an-integrated-laboratory-information-management-system-lims-improve-food-beverage-manufacturing-quality\/\" target=\"_blank\">https:\/\/blogs.sw.siemens.com\/consumer-products-retail\/2022\/11\/10\/how-does-using-an-integrated-laboratory-information-management-system-lims-improve-food-beverage-manufacturing-quality\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+does+using+an+integrated+laboratory+information+management+system+%28LIMS%29+improve+food+%26+beverage+manufacturing+quality%3F&rft.atitle=&rft.aulast=Abazeri%2C+L.&rft.au=Abazeri%2C+L.&rft.date=10+November+2022&rft.pub=Siemens&rft_id=https%3A%2F%2Fblogs.sw.siemens.com%2Fconsumer-products-retail%2F2022%2F11%2F10%2Fhow-does-using-an-integrated-laboratory-information-management-system-lims-improve-food-beverage-manufacturing-quality%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-F.26SBigData21-18\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-F.26SBigData21_18-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Frost & Sullivan (February 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.marketresearch.com\/Frost-Sullivan-v383\/Big-Data-Analytics-Artificial-Intelligence-14233934\/\" target=\"_blank\">\"Big Data Analytics and Artificial Intelligence are Driving the Global LIMS Market\"<\/a>. <i>MarketResearch.com<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.marketresearch.com\/Frost-Sullivan-v383\/Big-Data-Analytics-Artificial-Intelligence-14233934\/\" target=\"_blank\">https:\/\/www.marketresearch.com\/Frost-Sullivan-v383\/Big-Data-Analytics-Artificial-Intelligence-14233934\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Big+Data+Analytics+and+Artificial+Intelligence+are+Driving+the+Global+LIMS+Market&rft.atitle=MarketResearch.com&rft.aulast=Frost+%26+Sullivan&rft.au=Frost+%26+Sullivan&rft.date=February+2021&rft_id=https%3A%2F%2Fwww.marketresearch.com%2FFrost-Sullivan-v383%2FBig-Data-Analytics-Artificial-Intelligence-14233934%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-19\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-19\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Scholten, Bianca (2007). <a rel=\"nofollow\" class=\"external text\" href=\"#v=onepage&q=manufacturing%20system%20integration%20%22LIMS%22&f=false\">\"Chapter 4: Applying ISA-95 to Vertical Integration\"<\/a>. <i>The road to integration: a guide to applying the ISA-95 standard in manufacturing<\/i>. Research Triangle Park NC: ISA. pp. 167\u201393. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-9792343-8-5<span class=\"printonly\">. <a rel=\"nofollow\" class=\"external free\" href=\"#v=onepage&q=manufacturing%20system%20integration%20%22LIMS%22&f=false\">https:\/\/books.google.com\/books?id=-UQ0knDacZsC&pg=PA189&dq=manufacturing+system+integration+%22LIMS%22&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjTuuO0sNz-AhXHlWoFHfj9A1EQ6AF6BAgCEAI#v=onepage&q=manufacturing%20system%20integration%20%22LIMS%22&f=false<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+4%3A+Applying+ISA-95+to+Vertical+Integration&rft.atitle=The+road+to+integration%3A+a+guide+to+applying+the+ISA-95+standard+in+manufacturing&rft.aulast=Scholten&rft.aufirst=Bianca&rft.au=Scholten%2C%26%2332%3BBianca&rft.date=2007&rft.pages=pp.%26nbsp%3B167%E2%80%9393&rft.place=Research+Triangle+Park+NC&rft.pub=ISA&rft.isbn=978-0-9792343-8-5&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3D-UQ0knDacZsC%26pg%3DPA189%26dq%3Dmanufacturing%2Bsystem%2Bintegration%2B%2522LIMS%2522%26hl%3Den%26newbks%3D1%26newbks_redir%3D0%26sa%3DX%26ved%3D2ahUKEwjTuuO0sNz-AhXHlWoFHfj9A1EQ6AF6BAgCEAI%23v%3Donepage%26q%3Dmanufacturing%2520system%2520integration%2520%2522LIMS%2522%26f%3Dfalse&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SmithInteg19-20\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-SmithInteg19_20-0\">20.0<\/a><\/sup> <sup><a href=\"#cite_ref-SmithInteg19_20-1\">20.1<\/a><\/sup> <sup><a href=\"#cite_ref-SmithInteg19_20-2\">20.2<\/a><\/sup> <sup><a href=\"#cite_ref-SmithInteg19_20-3\">20.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Smith, K. (2 July 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/foodsafetytech.com\/feature_article\/integrated-informatics-optimizing-food-quality-and-safety-by-building-regulatory-compliance-into-the-supply-chain\/\" target=\"_blank\">\"Integrated Informatics: Optimizing Food Quality and Safety by Building Regulatory Compliance into the Supply Chain\"<\/a>. <i>Food Safety Tech<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/foodsafetytech.com\/feature_article\/integrated-informatics-optimizing-food-quality-and-safety-by-building-regulatory-compliance-into-the-supply-chain\/\" target=\"_blank\">https:\/\/foodsafetytech.com\/feature_article\/integrated-informatics-optimizing-food-quality-and-safety-by-building-regulatory-compliance-into-the-supply-chain\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Integrated+Informatics%3A+Optimizing+Food+Quality+and+Safety+by+Building+Regulatory+Compliance+into+the+Supply+Chain&rft.atitle=Food+Safety+Tech&rft.aulast=Smith%2C+K.&rft.au=Smith%2C+K.&rft.date=2+July+2019&rft_id=https%3A%2F%2Ffoodsafetytech.com%2Ffeature_article%2Fintegrated-informatics-optimizing-food-quality-and-safety-by-building-regulatory-compliance-into-the-supply-chain%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SiemensProcess22-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SiemensProcess22_21-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/assets.new.siemens.com\/siemens\/assets\/api\/uuid:ca5438d3-5b52-4b41-aae0-aaaa3685484e\/pibr-00021-0820-food-bev-portrait.pdf\" target=\"_blank\">\"Food & Beverage Process Automation and Instrumentation\"<\/a> (PDF). Siemens Industry, Inc. 2022<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/assets.new.siemens.com\/siemens\/assets\/api\/uuid:ca5438d3-5b52-4b41-aae0-aaaa3685484e\/pibr-00021-0820-food-bev-portrait.pdf\" target=\"_blank\">https:\/\/assets.new.siemens.com\/siemens\/assets\/api\/uuid:ca5438d3-5b52-4b41-aae0-aaaa3685484e\/pibr-00021-0820-food-bev-portrait.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Food+%26+Beverage+Process+Automation+and+Instrumentation&rft.atitle=&rft.date=2022&rft.pub=Siemens+Industry%2C+Inc&rft_id=https%3A%2F%2Fassets.new.siemens.com%2Fsiemens%2Fassets%2Fapi%2Fuuid%3Aca5438d3-5b52-4b41-aae0-aaaa3685484e%2Fpibr-00021-0820-food-bev-portrait.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Astrix2020LIMS-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Astrix2020LIMS_22-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/astrixinc.com\/wp-content\/uploads\/2021\/03\/Astrix-2020-LIMS-Market-Research-Report.pdf\" target=\"_blank\">\"Astrix 2020 LIMS Market Research Survey Report\"<\/a> (PDF). Astrix Technology, LLC. March 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/astrixinc.com\/wp-content\/uploads\/2021\/03\/Astrix-2020-LIMS-Market-Research-Report.pdf\" target=\"_blank\">https:\/\/astrixinc.com\/wp-content\/uploads\/2021\/03\/Astrix-2020-LIMS-Market-Research-Report.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Astrix+2020+LIMS+Market+Research+Survey+Report&rft.atitle=&rft.date=March+2021&rft.pub=Astrix+Technology%2C+LLC&rft_id=https%3A%2F%2Fastrixinc.com%2Fwp-content%2Fuploads%2F2021%2F03%2FAstrix-2020-LIMS-Market-Research-Report.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CardosoFromBench23-23\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CardosoFromBench23_23-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Cardoso, R.; Kinscher, K.; Ruof, T. et al. (8 March 2023). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mckinsey.com\/industries\/life-sciences\/our-insights\/from-bench-to-bedside-transforming-r-and-d-labs-through-automation\" target=\"_blank\">\"From bench to bedside: Transforming R&D labs through automation\"<\/a>. <i>McKinsey & Company<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.mckinsey.com\/industries\/life-sciences\/our-insights\/from-bench-to-bedside-transforming-r-and-d-labs-through-automation\" target=\"_blank\">https:\/\/www.mckinsey.com\/industries\/life-sciences\/our-insights\/from-bench-to-bedside-transforming-r-and-d-labs-through-automation<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=From+bench+to+bedside%3A+Transforming+R%26D+labs+through+automation&rft.atitle=McKinsey+%26+Company&rft.aulast=Cardoso%2C+R.%3B+Kinscher%2C+K.%3B+Ruof%2C+T.+et+al.&rft.au=Cardoso%2C+R.%3B+Kinscher%2C+K.%3B+Ruof%2C+T.+et+al.&rft.date=8+March+2023&rft_id=https%3A%2F%2Fwww.mckinsey.com%2Findustries%2Flife-sciences%2Four-insights%2Ffrom-bench-to-bedside-transforming-r-and-d-labs-through-automation&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-McDermottHowDig18-24\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-McDermottHowDig18_24-0\">24.0<\/a><\/sup> <sup><a href=\"#cite_ref-McDermottHowDig18_24-1\">24.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">McDermott, P. (31 July 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/foodsafetytech.com\/column\/how-digital-solutions-support-supply-chain-transparency-and-traceability\/\" target=\"_blank\">\"How Digital Solutions Support Supply Chain Transparency and Traceability\"<\/a>. <i>Food Safety Tech<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/foodsafetytech.com\/column\/how-digital-solutions-support-supply-chain-transparency-and-traceability\/\" target=\"_blank\">https:\/\/foodsafetytech.com\/column\/how-digital-solutions-support-supply-chain-transparency-and-traceability\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+Digital+Solutions+Support+Supply+Chain+Transparency+and+Traceability&rft.atitle=Food+Safety+Tech&rft.aulast=McDermott%2C+P.&rft.au=McDermott%2C+P.&rft.date=31+July+2018&rft_id=https%3A%2F%2Ffoodsafetytech.com%2Fcolumn%2Fhow-digital-solutions-support-supply-chain-transparency-and-traceability%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-EvansTheDig19-25\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EvansTheDig19_25-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Evans, K. (15 November 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/foodsafetytech.com\/feature_article\/the-digital-transformation-of-global-food-security\/\" target=\"_blank\">\"The Digital Transformation of Global Food Security\"<\/a>. <i>Food Safety Tech<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/foodsafetytech.com\/feature_article\/the-digital-transformation-of-global-food-security\/\" target=\"_blank\">https:\/\/foodsafetytech.com\/feature_article\/the-digital-transformation-of-global-food-security\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+Digital+Transformation+of+Global+Food+Security&rft.atitle=Food+Safety+Tech&rft.aulast=Evans%2C+K.&rft.au=Evans%2C+K.&rft.date=15+November+2019&rft_id=https%3A%2F%2Ffoodsafetytech.com%2Ffeature_article%2Fthe-digital-transformation-of-global-food-security%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ApteIsYour20-26\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ApteIsYour20_26-0\">26.0<\/a><\/sup> <sup><a href=\"#cite_ref-ApteIsYour20_26-1\">26.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Apte, A. (20 October 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/foodsafetytech.com\/column\/is-your-food-testing-lab-prepping-for-an-iso-iec-17025-audit\/\" target=\"_blank\">\"Is Your Food Testing Lab Prepping for an ISO\/IEC 17025 Audit?\"<\/a>. <i>Food Safety Tech<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/foodsafetytech.com\/column\/is-your-food-testing-lab-prepping-for-an-iso-iec-17025-audit\/\" target=\"_blank\">https:\/\/foodsafetytech.com\/column\/is-your-food-testing-lab-prepping-for-an-iso-iec-17025-audit\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Is+Your+Food+Testing+Lab+Prepping+for+an+ISO%2FIEC+17025+Audit%3F&rft.atitle=Food+Safety+Tech&rft.aulast=Apte%2C+A.&rft.au=Apte%2C+A.&rft.date=20+October+2020&rft_id=https%3A%2F%2Ffoodsafetytech.com%2Fcolumn%2Fis-your-food-testing-lab-prepping-for-an-iso-iec-17025-audit%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PaszkoHow15-27\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PaszkoHow15_27-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Paszko, C. (26 October 2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/foodsafetytech.com\/feature_article\/how-lims-facilitates-iso-17025-certification-in-food-testing-labs\/\" target=\"_blank\">\"How LIMS Facilitates ISO 17025 Certification in Food Testing Labs\"<\/a>. <i>Food Safety Tech<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/foodsafetytech.com\/feature_article\/how-lims-facilitates-iso-17025-certification-in-food-testing-labs\/\" target=\"_blank\">https:\/\/foodsafetytech.com\/feature_article\/how-lims-facilitates-iso-17025-certification-in-food-testing-labs\/<\/a><\/span><span class=\"reference-accessdate\">. 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(6 August 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/foodsafetytech.com\/feature_article\/how-advanced-lims-brings-control-consistency-and-compliance-to-food-safety\/\" target=\"_blank\">\"How Advanced LIMS Brings Control, Consistency and Compliance to Food Safety\"<\/a>. <i>Food Safety Tech<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/foodsafetytech.com\/feature_article\/how-advanced-lims-brings-control-consistency-and-compliance-to-food-safety\/\" target=\"_blank\">https:\/\/foodsafetytech.com\/feature_article\/how-advanced-lims-brings-control-consistency-and-compliance-to-food-safety\/<\/a><\/span><span class=\"reference-accessdate\">. 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Ahmed, Amira; Gonzalez, Nancy; Alvarnas, Joseph; Digiusto, David (1 January 2012). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1465324912706205\" target=\"_blank\">\"Implementation of a configurable laboratory information management system for use in cellular process development and manufacturing\"<\/a> (in en). <i>Cytotherapy<\/i> <b>14<\/b> (1): 114\u2013121. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.3109%2F14653249.2011.619007\" target=\"_blank\">10.3109\/14653249.2011.619007<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1465324912706205\" target=\"_blank\">https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1465324912706205<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Implementation+of+a+configurable+laboratory+information+management+system+for+use+in+cellular+process+development+and+manufacturing&rft.jtitle=Cytotherapy&rft.aulast=Russom&rft.aufirst=Diana&rft.au=Russom%2C%26%2332%3BDiana&rft.au=Ahmed%2C%26%2332%3BAmira&rft.au=Gonzalez%2C%26%2332%3BNancy&rft.au=Alvarnas%2C%26%2332%3BJoseph&rft.au=Digiusto%2C%26%2332%3BDavid&rft.date=1+January+2012&rft.volume=14&rft.issue=1&rft.pages=114%E2%80%93121&rft_id=info:doi\/10.3109%2F14653249.2011.619007&rft_id=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1465324912706205&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FamiliLab22-41\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-FamiliLab22_41-0\">41.0<\/a><\/sup> <sup><a href=\"#cite_ref-FamiliLab22_41-1\">41.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation\" id=\"rdp-ebb-CITEREFFamiliCleary2022\">Famili, Parsa; 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Law+firms+must+manage+cybersecurity+risks&rft.atitle=ABA+Journal&rft.aulast=Sobowale%2C+J.&rft.au=Sobowale%2C+J.&rft.date=1+March+2017&rft.pub=American+Bar+Association&rft_id=http%3A%2F%2Fwww.abajournal.com%2Fmagazine%2Farticle%2Fmanaging_cybersecurity_risk%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WatneyAddress17-48\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WatneyAddress17_48-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Watney, C.; Draffin, C. (November 2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.rstreet.org\/wp-content\/uploads\/2018\/04\/118-1.pdf\" target=\"_blank\">\"Addressing new challenges in automotive cybersecurity\"<\/a> (PDF). <i>R Street Policy Study No. 118<\/i>. R Street Institute<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.rstreet.org\/wp-content\/uploads\/2018\/04\/118-1.pdf\" target=\"_blank\">https:\/\/www.rstreet.org\/wp-content\/uploads\/2018\/04\/118-1.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Addressing+new+challenges+in+automotive+cybersecurity&rft.atitle=R+Street+Policy+Study+No.+118&rft.aulast=Watney%2C+C.%3B+Draffin%2C+C.&rft.au=Watney%2C+C.%3B+Draffin%2C+C.&rft.date=November+2017&rft.pub=R+Street+Institute&rft_id=https%3A%2F%2Fwww.rstreet.org%2Fwp-content%2Fuploads%2F2018%2F04%2F118-1.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LewisEcon18-49\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LewisEcon18_49-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Lewis, J.A. (21 February 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.csis.org\/analysis\/economic-impact-cybercrime\" target=\"_blank\">\"Economic Impact of Cybercrime\"<\/a>. Center for Strategic & International Studies<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.csis.org\/analysis\/economic-impact-cybercrime\" target=\"_blank\">https:\/\/www.csis.org\/analysis\/economic-impact-cybercrime<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Economic+Impact+of+Cybercrime&rft.atitle=&rft.aulast=Lewis%2C+J.A.&rft.au=Lewis%2C+J.A.&rft.date=21+February+2018&rft.pub=Center+for+Strategic+%26+International+Studies&rft_id=https%3A%2F%2Fwww.csis.org%2Fanalysis%2Feconomic-impact-cybercrime&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SBDCC_BlogCost17-50\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SBDCC_BlogCost17_50-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20200705061737\/https:\/\/www.virginiasbdc.org\/blog-cost-of-cyber-crime-to-small-businesses\/\" target=\"_blank\">\"BLOG: Cost of Cyber Crime to Small Businesses\"<\/a>. <i>Virginia SBDC Blog<\/i>. Virginia SBDC. 30 May 2017. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.virginiasbdc.org\/blog-cost-of-cyber-crime-to-small-businesses\/\" target=\"_blank\">the original<\/a> on 05 July 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20200705061737\/https:\/\/www.virginiasbdc.org\/blog-cost-of-cyber-crime-to-small-businesses\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20200705061737\/https:\/\/www.virginiasbdc.org\/blog-cost-of-cyber-crime-to-small-businesses\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=BLOG%3A+Cost+of+Cyber+Crime+to+Small+Businesses&rft.atitle=Virginia+SBDC+Blog&rft.date=30+May+2017&rft.pub=Virginia+SBDC&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20200705061737%2Fhttps%3A%2F%2Fwww.virginiasbdc.org%2Fblog-cost-of-cyber-crime-to-small-businesses%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HiscoxHiscox19.22-51\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HiscoxHiscox19.22_51-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hiscox.com\/documents\/2019-Hiscox-Cyber-Readiness-Report.pdf\" target=\"_blank\">\"Hiscox Cyber Readiness Report 2019\"<\/a> (PDF). Hiscox Ltd. April 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.hiscox.com\/documents\/2019-Hiscox-Cyber-Readiness-Report.pdf\" target=\"_blank\">https:\/\/www.hiscox.com\/documents\/2019-Hiscox-Cyber-Readiness-Report.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Hiscox+Cyber+Readiness+Report+2019&rft.atitle=&rft.date=April+2019&rft.pub=Hiscox+Ltd&rft_id=https%3A%2F%2Fwww.hiscox.com%2Fdocuments%2F2019-Hiscox-Cyber-Readiness-Report.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Galvin60_18-52\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Galvin60_18_52-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Galvin, J. (7 May 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.inc.com\/joe-galvin\/60-percent-of-small-businesses-fold-within-6-months-of-a-cyber-attack-heres-how-to-protect-yourself.html\" target=\"_blank\">\"60 Percent of Small Businesses Fold Within 6 Months of a Cyber Attack. Here's How to Protect Yourself\"<\/a>. <i>Inc.com<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.inc.com\/joe-galvin\/60-percent-of-small-businesses-fold-within-6-months-of-a-cyber-attack-heres-how-to-protect-yourself.html\" target=\"_blank\">https:\/\/www.inc.com\/joe-galvin\/60-percent-of-small-businesses-fold-within-6-months-of-a-cyber-attack-heres-how-to-protect-yourself.html<\/a><\/span><span class=\"reference-accessdate\">. 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(15 June 2022). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wpwhitesecurity.com\/why-malicious-hacker-target-wordpress\/\" target=\"_blank\">\"Top reasons why WordPress websites get hacked (and how you can stop it)\"<\/a>. WP White Security<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.wpwhitesecurity.com\/why-malicious-hacker-target-wordpress\/\" target=\"_blank\">https:\/\/www.wpwhitesecurity.com\/why-malicious-hacker-target-wordpress\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Top+reasons+why+WordPress+websites+get+hacked+%28and+how+you+can+stop+it%29&rft.atitle=&rft.aulast=Grima%2C+M.&rft.au=Grima%2C+M.&rft.date=15+June+2022&rft.pub=WP+White+Security&rft_id=https%3A%2F%2Fwww.wpwhitesecurity.com%2Fwhy-malicious-hacker-target-wordpress%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MoenWhatHack16-54\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MoenWhatHack16_54-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Moen, D. (19 April 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wordfence.com\/blog\/2016\/04\/hackers-compromised-wordpress-sites\/\" target=\"_blank\">\"What Hackers Do With Compromised WordPress Sites\"<\/a>. <i>Wordfence Blog<\/i>. Defiant, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.wordfence.com\/blog\/2016\/04\/hackers-compromised-wordpress-sites\/\" target=\"_blank\">https:\/\/www.wordfence.com\/blog\/2016\/04\/hackers-compromised-wordpress-sites\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=What+Hackers+Do+With+Compromised+WordPress+Sites&rft.atitle=Wordfence+Blog&rft.aulast=Moen%2C+D.&rft.au=Moen%2C+D.&rft.date=19+April+2016&rft.pub=Defiant%2C+Inc&rft_id=https%3A%2F%2Fwww.wordfence.com%2Fblog%2F2016%2F04%2Fhackers-compromised-wordpress-sites%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-TalalevWebsite19-55\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-TalalevWebsite19_55-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Talaleve, A. (22 February 2022). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/patchstack.com\/articles\/website-hacking-statistics\/\" target=\"_blank\">\"Website Hacking Statistics You Should Know in 2022\"<\/a>. Patchstack<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/patchstack.com\/articles\/website-hacking-statistics\/\" target=\"_blank\">https:\/\/patchstack.com\/articles\/website-hacking-statistics\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Website+Hacking+Statistics+You+Should+Know+in+2022&rft.atitle=&rft.aulast=Talaleve%2C+A.&rft.au=Talaleve%2C+A.&rft.date=22+February+2022&rft.pub=Patchstack&rft_id=https%3A%2F%2Fpatchstack.com%2Farticles%2Fwebsite-hacking-statistics%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NISTSecurity19-56\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NISTSecurity19_56-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/glossary\/term\/security_control\" target=\"_blank\">\"security control\"<\/a>. <i>Computer Security Resource Center<\/i>. National Institute of Standards and Technology. 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/csrc.nist.gov\/glossary\/term\/security_control\" target=\"_blank\">https:\/\/csrc.nist.gov\/glossary\/term\/security_control<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=security+control&rft.atitle=Computer+Security+Resource+Center&rft.date=2019&rft.pub=National+Institute+of+Standards+and+Technology&rft_id=https%3A%2F%2Fcsrc.nist.gov%2Fglossary%2Fterm%2Fsecurity_control&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CiocoiuTheRole10-57\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CiocoiuTheRole10_57-0\">57.0<\/a><\/sup> <sup><a href=\"#cite_ref-CiocoiuTheRole10_57-1\">57.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Ciocoui, C.N.; Dobrea, R.C. (2010). \"Chapter 1. The Role of Standardization in Improving the Effectiveness of Integrated Risk Management\". In Nota, G.. <i>Advances in Risk Management<\/i>. IntechOpen. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.5772%2F9893\" target=\"_blank\">10.5772\/9893<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9789535159469.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+1.+The+Role+of+Standardization+in+Improving+the+Effectiveness+of+Integrated+Risk+Management&rft.atitle=Advances+in+Risk+Management&rft.aulast=Ciocoui%2C+C.N.%3B+Dobrea%2C+R.C.&rft.au=Ciocoui%2C+C.N.%3B+Dobrea%2C+R.C.&rft.date=2010&rft.pub=IntechOpen&rft_id=info:doi\/10.5772%2F9893&rft.isbn=9789535159469&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JPMorganData18-58\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-JPMorganData18_58-0\">58.0<\/a><\/sup> <sup><a href=\"#cite_ref-JPMorganData18_58-1\">58.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jpmorganchase.com\/content\/dam\/jpmc\/jpmorgan-chase-and-co\/documents\/call-to-action.pdf\" target=\"_blank\">\"Data Standardization: A Call to Action\"<\/a> (PDF). JPMorgan Chase & Co. May 2018<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.jpmorganchase.com\/content\/dam\/jpmc\/jpmorgan-chase-and-co\/documents\/call-to-action.pdf\" target=\"_blank\">https:\/\/www.jpmorganchase.com\/content\/dam\/jpmc\/jpmorgan-chase-and-co\/documents\/call-to-action.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Data+Standardization%3A+A+Call+to+Action&rft.atitle=&rft.date=May+2018&rft.pub=JPMorgan+Chase+%26+Co&rft_id=https%3A%2F%2Fwww.jpmorganchase.com%2Fcontent%2Fdam%2Fjpmc%2Fjpmorgan-chase-and-co%2Fdocuments%2Fcall-to-action.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230516215523\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.666 seconds\nReal time usage: 0.700 seconds\nPreprocessor visited node count: 43426\/1000000\nPost\u2010expand include size: 378250\/2097152 bytes\nTemplate argument size: 120290\/2097152 bytes\nHighest expansion depth: 25\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 108932\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 632.961 1 -total\n 92.19% 583.506 1 Template:Reflist\n 74.04% 468.657 58 Template:Citation\/core\n 47.79% 302.503 39 Template:Cite_web\n 18.15% 114.872 12 Template:Cite_journal\n 14.34% 90.789 45 Template:Date\n 10.88% 68.852 4 Template:Cite_book\n 7.79% 49.339 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\n 5.53% 35.006 3 Template:Citation\n 4.67% 29.532 30 Template:Citation\/identifier\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14178-0!canonical and timestamp 20230516215522 and revision id 52000. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","65f78607cbccba23967db83197332e4c_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/50\/Microwave_Microsystems_Laboratory_-_51997578036.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/5e\/Measuring_cybersecurity.png","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/f\/f4\/Lies-pound-yen-euro-dollar.png"],"65f78607cbccba23967db83197332e4c_timestamp":1684275143,"829960d7b100216b435c1232f06318e6_type":"article","829960d7b100216b435c1232f06318e6_title":"2.2 Regulations and laws around the world","829960d7b100216b435c1232f06318e6_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world","829960d7b100216b435c1232f06318e6_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Standards and regulations affecting manufacturing labs\/Regulations and laws around the worldFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 2.2 Regulations and laws around the world \n\n1.1 2.2.1 Food and beverage \n1.2 2.2.2 Materials \n1.3 2.2.3 Pharmaceutical and medical devices \n1.4 2.3.4 Other industries and regulations \n\n\n2 References \n3 Citation information for this chapter \n\n\n\n2.2 Regulations and laws around the world \nAs the end of Chapter 1 highlighted, today's regulatory focus on product safety, quality, and efficacy is largely built on the past failures, injuries, and deaths that highlighted the regulatory need.[1][2][3][4] For example, the consumption of raw milk was associated with a growing number of health issues in the mid- to late 1800s, particularly milk from unscrupulous dairy farms. In the U.S. Northeast during the 1860s, recognition was growing concerning the threat that tainted milk originating from dairy cows being singularly fed distillery byproducts had to human health. Not only was the milk generated from such cows thin and low in nutrients, but it also was adulterated with questionable substances to give it a better appearance. This resulted in many children and adults falling ill or dying from consuming the product. The efforts of Dr. Henry Coit and others in the late 1800s to develop a certification program for milk\u2014which included laboratory testing among other activities\u2014eventually helped plant the seeds for a national food and beverage safety program.[5] By 1939, the U.S. Public Health Services had drafted the Model Milk Health Ordinance \"in order to encourage a greater uniformity of milk-control practice in the United States.\"[6]\nWhile regulation can at times be overbearing and harmful, well-crafted regulations can definitely benefit our society. This can be seen with manufacturing regulations driven on safety, quality, and efficacy principles. How those regulations are implemented around the world may differ slightly, however, which should not be surprising given the cultural, political, and functional differences across regions and nations of the world.[7] \nThe following subsections examine some of the more critical regulations that apply to a wide variety of manufacturing industries, from various parts of the world.\n\n2.2.1 Food and beverage \nThe safety and quality of food is a high priority for most countries around the world, though how that safety and quality is regulated and legislated varies, sometimes significantly. The following subsections briefly address the primary regulations and legislation enacted in seven major countries and supranational unions around the world. (It is beyond the scope of this guide to address them all.) Similarities among the countries may be seen in their goals, but it should be noted that differences\u2014significant and nuanced\u2014exist among them all in regards to regulatory approaches to sampling, testing, risk, and importing of products.[7][8][9][10] \n2.2.1.1 Food Safety Act 1990 and Food Standards Act 1999 - United Kingdom\nThe Food Safety Act of 1990 and Food Standards Act of 1999 represent the core of food safety regulation in the United Kingdom, though there are other pieces of legislation that also have an impact.[11][12] The Food Safety Act of 1990 encourages entities to \"not include anything in food, remove anything from food, or treat food in any way which means it would be damaging to the health of people eating it\"; serve or sell food that is of a quality that \"consumers would expect\"; and ensure food is labeled, advertised, and presented clearly and truthfully.[11][12] The Food Standards Act of 1999 later created the UK's Food Standards Agency (FSA) \"to protect public health from risks which may arise in connection with the consumption of food (including risks caused by the way in which it is produced or supplied) and otherwise to protect the interests of consumers in relation to food.\"[13] One of the ways the FSA does this is through enforcing food safety regulation at the local level, including within food production facilities, as well as setting ingredient and nutrition labeling policy.[14] Regulations and guidance from the FSA address not only labelling but also radioactivity monitoring, meat processing, manure management, Salmonella testing, temperature control, dairy hygiene, and more.[15]\n2.2.1.2 Food Safety and Standards Act of 2006 - India\nThis act was enacted in 2006 to both consolidate existing food-related law and to establish the Food Safety and Standards Authority of India (FSSAI), which develops regulations and standards of practice for the manufacture, storage, distribution, and packaging of food.[16][17] However, an audit of FSSAI by the Comptroller and Auditor General of India (CAG) in December 2017 revealed some deficiencies in the FSSAI's activities, including an overall \"low quality\" of food testing laboratories in the country.[16] Nonetheless, the FSSAI remains the primary regulatory watchdog, developing standards and guidelines for food and enforcing those standards. This includes setting limits for food additives, contaminants, pesticides, drugs, heavy metals, and more, as well as defining quality control mechanisms, accreditation requirements, sampling and analytical techniques, and more.[17]\n2.2.1.3 Food Safety Law - China\nThe Food Safety Law is described as \"the fundamental law regulating food safety in China.\"[18] Enacted in 2009 and revised in 2015, the Law \"builds up the basic legal framework for food safety supervision and management\" and \"introduces many new regulatory requirements,\" including \"not only general requirements applicable to food and food additives, but also specific requirements for food-related products and other product categories.\"[18] Among these activities, the Law describes how food testing laboratories shall conduct their activities, from accreditation and sampling to testing and reporting.[19]\n2.2.1.4 Food Sanitation Act and Food Safety Basic Act - Japan\nThe Food Sanitation Act of 1947 and the Food Safety Basic Act of 2003 represent the most important pieces of food-related legislation in Japan, though there are others. The Food Sanitation Act was originally enacted \"to prevent sanitation hazards resulting from eating and drinking by enforcing regulations and other measures necessary from the viewpoint of public health, to ensure food safety and thereby to protect citizens' health.\"[20] The Food Safety Basic Act recognized the effects of \"internationalization\" and changing dietary habits, as well as scientific and technological shifts in food production, as a primary driver for modernizing food safety and sustainability in the country, and it also created the Food Safety Commission of Japan.[21] Between the two pieces of legislation, standards and specifications for food and food additives, as well as associated tools and packaging, are addressed, as are inspection standards, production standards, hygiene management, and individual food and ingredient safety.[22]\n2.2.1.5 Food Safety Modernization Act (FSMA) and other acts - United States\nThe Food Safety Modernization Act of the United States was signed into law in January 2011, giving the US Food and Drug Administration (FDA) more regulatory authority to address the way food is grown, harvested, and processed.[23][24] It has been described by the FDA as \"the most sweeping reform of our food safety laws in more than 70 years.\"[24] The FSMA, at its base, has five key aspects, addressing preventive controls, inspection and compliance, safety of food imports, mandatory recall response, and food partnership enhancement.[24] However, FSMA continues to evolve, with additional rules getting added since its enactment, including rules about record management, good manufacturing practice (GMP) for human food and animal feed, and laboratory accreditation (referred to as the LAAF Rule).[25]\nAnother important regulatory body in the US is the Food Safety and Inspection Service (FSIS), which is overseen by the US Department of Agriculture (USDA). The FSIS and its authority to regulate are derived from three different acts: the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957, and the Egg Products Inspection Act of 1970.[26] The FSIS has developed its own regulatory requirements for meat, poultry, and egg products, including for inspections, imports and exports, labeling, and laboratory testing.[27][28][29]\n2.2.1.6 General Food Law Regulation (GFLR) - European Union\nThe GFLR was enacted across the European Union in 2002 as part of Regulation (EC) No 178\/2002, and it is described as \"the foundation of food and feed law\" for the EU.[30] Along with setting requirements and procedures for food and feed safety, the GFLR also mandated the creation of the European Food Safety Authority (EFSA), an independent body assigned to developing sound scientific advice about and providing support towards the goals of food, beverage, and feed safety in the EU.[23][30] As such, the EFSA develops broad and sector-specific guidance[31], as well as other rules related to scientific assessment of food safety matters, e.g., Regulation (EC) No 2073\/2005 on microbiological criteria for foodstuffs.[32] The EFSA also develops food classification standardization tools such as the Standard Sample Description (SSD2) data model, to better ensure an appropriate \"format for describing food and feed samples and analytical results that is used by EFSA\u2019s data providers.\"[33]\n2.2.1.7 Safe Food for Canadians Act (SFCA) - Canada\nIn November 2012, the SFCA was enacted to place regulatory \"focus on prevention to ensure a food that is imported, exported or shipped from one province to another, is manufactured, stored, packaged and labelled in a way that does not present a risk of contamination.\"[34][35] Though Canadian Food Inspection Agency (CFIA) enforcement of the SFCA's regulations didn't start until January 2019[34], the consolidation of 14 sets of existing food regulations by the SFCA has managed to improve consistency, reduce administrative burden, and enable food business innovation.[36] An interpretive guide published by the CFIA, Understanding the Safe Food for Canadians Regulations: A handbook for food businesses, summarizes and explains some of the nuances of the SFCA and its 16 parts on matters such as trade, licensing, preventive controls, packaging and labeling, and traceability.[36]\n\n2.2.2 Materials \n\nLike materials standards, there are too many materials regulations to list for the given scope of this guide. However, several different examples are given below of materials-related regulations found in various parts of the world.\n2.2.2.1 21 CFR Part 175 and 176 - United States\nThese two regulations from the U.S. Code of Federal Regulations system relate specifically to the materials used to package food. (While the food and beverage industry is the recipient and end user of such materials, the materials researcher and manufacturer is responsible, in part, for developing and producing materials that meet such regulations.) Part 175 dictates what substances can be used as components of adhesives and coatings in food packaging materials[37], and Part 176 addresses what substances can be used as components of paper and paperboard in food packaging materials.[38]\n2.2.2.2 Building Standard Law - Japan\nJapan's Building Standard Law, broadly speaking, states a minimum set of standards that must be followed concerning the construction of buildings in the country, in order to protect the health and property of those using those buildings. Given the country's infrastructure is affected by snow accumulation, earthquakes, and tsunamis, a modern approach to building regulation was required in 1950. One section of the law addresses the quality of materials used in building construction, particularly in important sections of the home such as the foundation, load-bearing walls, columns, and more. The regulation mandates that such materials must conform to the Japanese Industrial Standard or Japanese Agriculture Standard, or that they be specifically approved by the Minister. This means manufacturers of structural steel, high-strength bolts, concrete, wood-based composite panels, membrane materials, and more are largely beholden to those standards throughout the manufacturing process.[39]\n2.2.2.3 The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - United Kingdom\nIn 1988, the U.K. made into law The Furniture and Furnishings (Fire) (Safety) Regulations, which \"were introduced to help reduce the risks of injury or loss of life through fires in the home spread by upholstered furniture.\"[40] The regulations set out general testing requirements for foam fillings, non-foam fillings, composite fillings, and cover materials, requiring that they pass various material and combustion requirements.[41] Various updates have been made to the regulations over time. In 2019, the government, noting \"growing evidence linking the specific flame-retardant chemicals most often used in furniture to serious long-term health impacts,\" acknowledged that updates to regulations on the materials used in furniture making were required, which would in turn further dictate manufacturing processes.\n2.2.2.4 National Environment Protection (Used Packaging Materials) Measure 2011 - Australia\nIn September 2011, Australia's National Environment Protection Council made law the National Environment Protection (Used Packaging Materials) Measure 2011. Signatories of the Covenant agreed to \"a voluntary system of industry self regulation\" to better ensure \"improved environmental outcomes\" in regards to packaging material use and re-use.[42] However, a 2021 review found that the regulation was lacking in several areas, including with monitoring and enforcement. A December 2022 response by the government agreed, noting, \"[l]ack of compliance monitoring and enforcement activity has undermined the effectiveness of, and confidence in, the mandatory co-regulatory arrangement and enabled some businesses to avoid their obligations.\" Updates to the regulations are expected by 2025, \"to ensure that all packaging available in Australia is designed to be recovered, reused, recycled and reprocessed safely in line with circular economy principles. Reforming the regulation of packaging in Australia presents a significant opportunity to improve the way our packaging is designed ...\"[43] As this language suggests, such regulatory changes, should they come, will further dictate the materials designed and used in manufacturing processes in the country.\n2.2.2.5 Surface Coating Materials Regulations (SOR\/2016-193) - Canada\nEnacted in 2016, these regulations\u2014enabled by Canada's Consumer Product Safety Act\u2014dictate the amount of lead and mercury allowed in surface coating materials, stickers, and films under certain circumstances. The testing for those heavy metals must be done by manufacturers (or their third-party labs) \"in accordance with a method that conforms to good laboratory practices.\"[44]\n\n2.2.3 Pharmaceutical and medical devices \nAs was similarly noted in the section about pharmaceutical and medical device standards, regulations in this industry are vital for ensuring the safety of consumers and the efficacy of the drugs and devices they use, and they are typically present as some of the most rigorous regulations for the broad world of manufacturing. That said, as serious as pharmaceutical regulation can be, governments can often be slow to act with their regulatory duties[45] or have complex governance structures and difficult-to-enforce rules.[46][47] As these regulatory bodies and their regulations improve, manufacturers of pharmaceuticals and medical devices find themselves needing to be even more efficient in their activities and focused on good manufacturing practices.\nThe following represent examples of pharmaceutical and medical device regulation around the world. Note that the discussion of GMP and cGMP is discussed further in the next section.\n2.2.3.1 Current Good Manufacturing Practice (cGMP) regulations - United States and other countries\nFor more on this, see the next section on other industries and regulations.\n2.2.3.2 Drugs and Cosmetics Act of 1940 - India\nThis act represents the primary regulatory control over the manufacture of pharmaceuticals and cosmetics in India. The act \"creates a web of regulatory authorities to govern the process at both the central and the state levels.\"[46] Like other pharmaceutical regulations in other countries, the act attempts to ensure that drugs, cosmetics, medical devices, and diagnostic devices sold in India are safe, standardized to a certain quality, and effective at what they are said to do. Public health activists, lawyers, and specialized agencies such as the WHO, however, have criticized India's regulatory efforts in recent years for not keeping up with the rapidly growing industry while exhibiting poor transparency, unnecessary complexity, and insufficient statutory backing (as seen with the Central Drugs Standard Control Organisation or CDSCO).[46][47] The country has been attempting to reform the regulatory system by, for example, updating the Indian Pharmacopoeia and the Drugs and Cosmetics Act with more modern, relevant information and improved labeling mechanisms for tracking and tracing drugs.[48]\n2.2.3.3 Food and Drugs Act - Canada\nCanada's Food and Drugs Act enables its Food and Drug Regulations, which, among other things, helps to \"ensure the pharmaceutical drugs offered for sale in Canada are safe, effective and of high quality.\"[49] Part C of the regulations addresses drugs in a broad sense, with Division 2 of that part regulating manufacturing controls, quality testing, and records management.[50] These regulations are overseen and updated by Health Canada \"through a combination of scientific review, monitoring, compliance, and enforcement activities.\"[45]\n2.2.3.4 Pharmaceutical Affairs Act (PAA) and Medical Devices Act (MDA) - South Korea\nOverseen by the Ministry of Food and Drug Safety (MFDS), these acts help ensure safer and effective pharmaceuticals and medical devices to the people of South Korea. The country's PAA classifies pharmaceuticals as either pharmaceutical ingredients or drug products, which in turn are broken down into new drugs, pharmaceuticals requiring specific data submissions, and generic drugs.[51] The PAA's goal is described as being \"to prescribe matters necessary to deal with pharmaceutical affairs smoothly, thereby contributing to the improvement of the national public health.\"[52] The MDA's goal is \"to promote the efficient management of medical devices and further contribute to the improvement of public health by providing for matters concerning the manufacturing, import, distribution, etc. of medical devices.\"[53] Along with managing the regulations from these acts, the MFDS is also responsible for setting the manufacturing standards and specifications for pharmaceuticals, monitoring certain pre- and post-manufacturing procedures, enforcing good manufacturing practice, reinforcing safety controls, and more.[51]\n2.2.3.5 Pharmaceutical and Medical Device Act (PMD Act) - Japan\nThe PMD Act represents one of the primary pieces of pharmaceutical and medical device regulation in Japan. The PMD Act replaced Japan's Pharmaceutical Affairs Law in November 2014, with the primary goal of using regulation to improve public health by assuring the quality, safety, and efficacy of pharmaceuticals, medical devices, and cosmetics, as well as preventing the expansion of activities harmful to those efforts. Under the PMD Act, manufacturers are expected to demonstrate how their products conform to Japan's regulations and how their operations are guided by a well-defined QMS.[54][55] The act has multiple chapters addressing the manufacturing of drugs, \"quasi-drugs,\" cosmetics, cellular and tissue-based products, medical devices, and in vitro diagnostic devices, as well as separate chapters on the safety of and standards applicable to drugs.[54] In regards to manufacturers of medical devices, they should turn to several sets of standards published by Japan's Ministry of Health, Labour and Welfare (MHLW)\u2014MO No. 169 \u2013 Standards for Manufacturing Control and Quality Control for Medical Devices and In Vitro Diagnostic Reagents and MO No. 135 \u2013 Standards for Good Vigilance Practice (GVP)\u2014in order to better comply with the PMD Act.[55]\n\n2.3.4 Other industries and regulations \nLike standards, manufacturing regulations exist beyond industries like the food and beverage, materials, and pharmaceutical industries. From electronics and automotive parts to cosmetics and chemicals, governments around the world place restrictions on and recommendations for testing a variety of manufactured goods. What follows are a few examples of regulations on other industries from various parts of the world.\n2.3.4.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP) - United States and other countries\nAs a broad concept, good manufacturing practice or GMP is an organized set of standards and guidelines that allow manufacturers of most any product to better ensure their products are consistently produced and packaged to a consistent level of quality. GMP tends to cover most every step of production, from planning recipes and choosing starting materials to training personnel and documenting processes.[56] The concept of GMP is often spoken of in terms of pharmaceutical and medical device manufacturing[51][56][57], though it is applicable to most any other production industry.[58][59]\nClosely related is the term \"current good manufacturing practice\" or cGMP. Both \"GMP\" and \"cGMP\" are largely interchangeable, though the latter is preferred in most regulatory language of the United States. A more nuanced take says that cGMP essentially represents the newest, most updated technologies implemented towards the goals of meeting GMP requirements.[60][61] \nIn the United States, cGMP\u2014in the context of pharmaceuticals\u2014is enshrined in numerous sections of Title 21 of the Code of Federal Regulations, including \"in parts 1-99, 200-299, 300-499, 600-799, and 800-1299.\"[62] The FDA describes these regulations as containing \"minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.\"[62] It also states safety, efficacy, and labeling requirements for manufactured drugs. These regulations require careful attention by manufacturers, lest they face seizure of their products, legal injunction, and criminal cases.[63]\nIn the context of food, cGMP principles were first introduced in the U.S. in 1969 as 21 CFR Part 110, though the concept of cGMP was modernized in 2015, in 21 CFR Part 117. This led to not only broad food- and beverage-based cGMPs but also cGMPs specific to a type of ingestible, including dietary supplements, infant formula, low-acid canned food, and bottled water.[64] \nGMP and cGMP contexts also exist for other manufacturing industries outside of pharmaceuticals and food, including automotive parts, medical devices, clothing, and more.[65] Additionally, these concepts are not limited to the U.S. For example, the World Health Organization has its own GMP\/cGMP guidelines for pharmaceuticals and biological medicines, with more than 100 countries reportedly incorporating those guidelines into their national medicine regulations.[66]\n2.3.4.2 Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation - European Union\nFor the E.U.'s chemical manufacturers and the other manufacturing industries depending on those chemicals, REACH represents one of the most expansive and complicated pieces of regulation in the E.U. Affecting potentially more than 140,000 substances, manufacturers of those substances are now largely responsible for identifying hazards, identifying mitigation methods for those hazards, and managing associated risks. Of particular note are \"substances of very high concern\" (SVHCs) and how they are authorized and restricted. This regulations means manufacturers must pay closer attention to what substances get put into their products and report on SVHCs making up more than 0.1 percent (by weight) of the product. These regulations may also mean the manufacturer may need to redesign their products with new substances.[67]\n2.3.4.3 Resolu\u00e7\u00e3o de diretoria colegiada - RDC n\u00ba 529 - Brazil\nThis Brazilian resolution, effective August 2021, revised the country's List of Prohibited Substances in Personal Hygiene, Cosmetics and Perfume Products to include additional substances. While it's not clear what original legislation houses that list, this list makes clear that manufacturers of personal hygiene, cosmetic, and perfume products have to be mindful of the ingredients they use in their manufacturing processes.[68]\n2.3.4.4 Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive - European Union\nThe E.U. uses the RoHS Directive as a means towards restricting the use of specific hazardous materials in the manufacture of electrical and electronic equipment (EEE), namely \"lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP).\"[69] By extension, the E.U. is encouraging safer alternatives for the manufacturing of EEE and fewer hazardous substances making their way into ecosystems from waste streams.\n2.3.4.5 Road Vehicle Standards (RVS) legislation - Australia\nComing into effect in July 2021 as a replacement to the Motor Vehicle Standards Act 1989, the RVS legislation brought regulation of road vehicle manufacturing into the twenty-first century, with updates to recalls, model reports, testing, and component type approvals. These regulations are backed by the Australian Design Rules (ADRs), which are national standards for vehicle safety.[70][71] Approved testing facilities are required to test that vehicles and their components are in compliance with ADRs and other relevant standards.[72]\n\nReferences \n\n\n\u2191 Center for Policy Alternatives at the Massachusetts Institute of Technology (1980). Benefits of Environmental, Health, and Safety Regulation. U.S. Government Printing Office. pp. 100. https:\/\/books.google.com\/books?id=VadeKZOzcmwC&pg=PA1 .   \n \n\n\u2191 Asch, Peter (1988). Consumer safety regulation: putting a price on life and limb. New York: Oxford University Press. pp. 3\u201314. ISBN 978-0-19-504972-5. https:\/\/books.google.com\/books?id=Pi_nCwAAQBAJ&pg=PA1 .   \n \n\n\u2191 Dwyer, Tom (1991). Life and death at work: industrial accidents as a case of socially produced error. Plenum studies in work and industry. New York: Plenum Press. ISBN 978-0-306-43949-0.   \n \n\n\u2191 CoVan, James (1995). Safety engineering. New dimensions in engineering. New York: Wiley. ISBN 978-0-471-55612-1.   \n \n\n\u2191 Lytton, Timothy D. (2019). \"Chapter 2: The Gospel of Clean Milk\". Outbreak: foodborne illness and the struggle for food safety. Chicago ; London: The University of Chicago Press. pp. 24-64. ISBN 978-0-226-61154-9.   \n \n\n\u2191 U.S. Public Health Service (1939). \"Milk ordinance and code: Recommended by the United States Public Health Service, 1939\". U.S. Government Printing Office. http:\/\/resource.nlm.nih.gov\/101528318 . Retrieved 05 May 2023 .   \n \n\n\u2191 7.0 7.1 Buzby, J.C.; Mitchell, L. (1 November 2003). \"Food Safety and Trade: Regulations, Risks, and Reconciliation\". Amber Waves. U.S. Department of Agriculture, Economic Research Service. https:\/\/www.ers.usda.gov\/amber-waves\/2003\/november\/food-safety-and-trade-regulations-risks-and-reconciliation\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 West, D.M.; Lansang, C. (10 July 2018). \"Global manufacturing scorecard: How the US compares to 18 other nations\". Brookings. https:\/\/www.brookings.edu\/research\/global-manufacturing-scorecard-how-the-us-compares-to-18-other-nations\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 U.S. Government Accountability Office (February 2005). \"Food Safety: Experiences of Seven Countries in Consolidating Their Food Safety Systems\". https:\/\/www.gao.gov\/products\/gao-05-212 . Retrieved 05 May 2023 .   \n \n\n\u2191 Whitworth, J. (22 February 2022). \"Report finds food testing policies different between countries\". Food Safety News. https:\/\/www.foodsafetynews.com\/2022\/02\/report-finds-food-testing-policies-different-between-countries\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 11.0 11.1 \"Food safety regulations\". Scarborough Borough Council. 10 November 2022. Archived from the original on 03 February 2023. https:\/\/web.archive.org\/web\/20230203164750\/https:\/\/www.scarborough.gov.uk\/home\/business-licensing-and-grants\/food-hygeine\/food-safety-regulations . Retrieved 05 May 2023 .   \n \n\n\u2191 12.0 12.1 \"Key regulations\". Food Standards Agency. 30 August 2022. https:\/\/www.food.gov.uk\/about-us\/key-regulations . Retrieved 05 May 2023 .   \n \n\n\u2191 \"1999 c. 28, The Food Standards Agency, Section 1\". legislation.gov.uk. https:\/\/www.legislation.gov.uk\/ukpga\/1999\/28\/section\/1 . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Food Standards Agency\". Gov.uk. https:\/\/www.gov.uk\/government\/organisations\/food-standards-agency . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Guidance and regulation: Food Standards Agency (FSA)\". Gov.uk. https:\/\/www.gov.uk\/search\/guidance-and-regulation?organisations%5B%5D=food-standards-agency&parent=food-standards-agency . Retrieved 05 May 2023 .   \n \n\n\u2191 16.0 16.1 \"Implementation of Food Safety and Standards Act, 2006\". PRS Legislative Research. https:\/\/prsindia.org\/policy\/report-summaries\/implementation-food-safety-and-standards-act-2006 . Retrieved 05 May 2023 .   \n \n\n\u2191 17.0 17.1 \"Food Safety and Standards Act, 2006\". Food Safety and Standards Authority of India. https:\/\/fssai.gov.in\/cms\/food-safety-and-standards-act-2006.php . Retrieved 05 May 2023 .   \n \n\n\u2191 18.0 18.1 Food and Agriculture Organization of the United Nations (24 April 2015). \"Food Safety Law (2015)\". Law and Environment Assistance Platform. United Nations Environmental Programme. https:\/\/leap.unep.org\/countries\/cn\/national-legislation\/food-safety-law-2015 . Retrieved 05 May 2023 .   \n \n\n\u2191 Foreign Agriculture Service Staff (18 May 2015). \"China's Food Safety Law (2015)\" (PDF). GAIN Repo. U.S. Department of Agriculture. https:\/\/apps.fas.usda.gov\/newgainapi\/api\/report\/downloadreportbyfilename?filename=Amended%20Food%20Safety%20Law%20of%20China_Beijing_China%20-%20Peoples%20Republic%20of_5-18-2015.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Food Sanitation Act (Act No. 233 of 1947)\". Japanese Law Translation. 24 December 1947. https:\/\/www.japaneselawtranslation.go.jp\/en\/laws\/view\/3687\/en . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Food Safety Basic Act\" (PDF). Food Safety Commission of Japan. 23 May 2003. https:\/\/www.fsc.go.jp\/english\/basic_act\/fs_basic_act.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 Baker McKenzie (2018). \"Japan: Food product and safety regulation\". Asia Pacific Food Law Guide. https:\/\/resourcehub.bakermckenzie.com\/en\/resources\/asia-pacific-food-law-guide\/asia-pacific\/japan\/topics\/food-product-and-safety-regulation . Retrieved 05 May 2023 .   \n \n\n\u2191 23.0 23.1 Weinroth, Margaret D; Belk, Aeriel D; Belk, Keith E (9 November 2018). \"History, development, and current status of food safety systems worldwide\" (in en). Animal Frontiers 8 (4): 9\u201315. doi:10.1093\/af\/vfy016. ISSN 2160-6056. PMC PMC6951898. PMID 32002225. https:\/\/academic.oup.com\/af\/article\/8\/4\/9\/5087923 .   \n \n\n\u2191 24.0 24.1 24.2 \"Food Safety Modernization Act and Animal Food\". U.S. Food and Drug Administration. 20 October 2022. https:\/\/www.fda.gov\/animal-veterinary\/animal-food-feeds\/food-safety-modernization-act-and-animal-food . Retrieved 05 May 2023 .   \n \n\n\u2191 \"FSMA Rules & Guidance for Industry\". U.S. Food and Drug Administration. 20 October 2022. https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/fsma-rules-guidance-industry#rules . Retrieved 05 May 2023 .   \n \n\n\u2191 Food Safety and Inspection Service (21 February 2018). \"Our History\". U.S. Department of Agriculture. https:\/\/www.fsis.usda.gov\/about-fsis\/history . Retrieved 05 May 2023 .   \n \n\n\u2191 \"9 CFR Part 412 - Label Approval\". Code of Federal Regulations. 31 October 2022. https:\/\/www.ecfr.gov\/current\/title-9\/chapter-III\/subchapter-E\/part-412 . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Federal Register Rules\". Food Safety and Inspection Service. https:\/\/www.fsis.usda.gov\/policy\/federal-register-rulemaking\/federal-register-rules . Retrieved 05 May 2023 .   \n \n\n\u2191 National Agricultural Library. \"Food Safety Standards\". U.S. Department of Agriculture. https:\/\/www.nal.usda.gov\/human-nutrition-and-food-safety\/food-safety-standards . Retrieved 05 May 2023 .   \n \n\n\u2191 30.0 30.1 \"General Food Law\". Food Safety. European Commission. https:\/\/food.ec.europa.eu\/horizontal-topics\/general-food-law_en . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Guidance and other assessment methodology documents\". European Food Safety Authority. https:\/\/www.efsa.europa.eu\/en\/methodology\/guidance . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Commission Regulation (EC) No 2073\/2005 of 15 November 2005 on microbiological criteria for foodstuffs\". EUR-Lex. 3 August 2020. https:\/\/eur-lex.europa.eu\/legal-content\/EN\/ALL\/?uri=CELEX%3A32005R2073 . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Food classification standardisation \u2013 The FoodEx2 system\". European Food Safety Authority. https:\/\/www.efsa.europa.eu\/en\/data\/data-standardisation . Retrieved 05 May 2023 .   \n \n\n\u2191 34.0 34.1 \"Safe Food for Canadians Act\". Manitoba Government. https:\/\/www.gov.mb.ca\/agriculture\/food-safety\/at-the-food-processor\/safe-food-for-canadians-act.html . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Safe Food for Canadians Act (S.C. 2012, c. 24)\". Justice Laws Website. Government of Canada. 17 June 2019. https:\/\/laws-lois.justice.gc.ca\/eng\/acts\/s-1.1\/index.html . Retrieved 05 May 2023 .   \n \n\n\u2191 36.0 36.1 Canadian Food Inspection Agency (2018). Understanding the Safe Food for Canadians Regulations: A handbook for food businesses. Government of Canada. ISBN 9780660269856. https:\/\/inspection.canada.ca\/food-safety-for-industry\/toolkit-for-food-businesses\/sfcr-handbook-for-food-businesses\/eng\/1481560206153\/1481560532540?chap=0 .   \n \n\n\u2191 \"Title 21, Chapter I, Subchapter B, Part 175\". Code of Federal Regulations. Office of the Federal Register; U.S. Government Publishing Office. 24 April 2023. https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-175?toc=1 . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Title 21, Chapter I, Subchapter B, Part 176\". Code of Federal Regulations. Office of the Federal Register; U.S. Government Publishing Office. 24 April 2023. https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-175?toc=1 . Retrieved 05 May 2023 .   \n \n\n\u2191 Tomohiro, H. (July 2013). \"Introduction to the Building Standard Law, Building Regulation in Japan\" (PDF). Building Center of Japan. https:\/\/www.bcj.or.jp\/upload\/international\/baseline\/BSLIntroduction201307_e.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 Office for Product Safety & Standards (July 2019). \"Updating The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - Government response to consultation\" (PDF). Crown. https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/822072\/furniture-fire-regulations-2016-consultation-government-response-july-2019.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 \"New upholstered furniture\". Business Companion. Chartered Trading Standards Institute. December 2022. https:\/\/www.businesscompanion.info\/en\/quick-guides\/product-safety\/new-upholstered-furniture . Retrieved 05 May 2023 .   \n \n\n\u2191 \"National Environment Protection (Used Packaging Materials) Measure 2011\". Federal Register of Legislation. Australian Government. 16 September 2011. https:\/\/www.legislation.gov.au\/Details\/F2011L02093 . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Australian Packaging Covenant\". Department of Climate Change, Energy, and Environment and Water. 2023. https:\/\/www.dcceew.gov.au\/environment\/protection\/waste\/plastics-and-packaging\/packaging-covenant . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Surface Coating Materials Regulations\". Justice Laws Website. Government of Canada. 19 December 2022. https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2016-193\/page-1.html . Retrieved 05 May 2023 .   \n \n\n\u2191 45.0 45.1 Office of the Auditor General of Canada (2011). \"Chapter 4: Regulating Pharmaceutical Drugs - Health Canada\" (PDF). Report of the Auditor General of Canada to the House of Commons. Minister of Public Works and Government Services. pp. 1\u201338. ISBN 9781100194028. https:\/\/publications.gc.ca\/collections\/collection_2012\/bvg-oag\/FA1-2011-2-4-eng.pdf .   \n \n\n\u2191 46.0 46.1 46.2 Basak, S. (13 February 2023). \"Indian Pharma Irregularities Point To Lack Of Drug Regulation Policies And Better Oversight\". Outlook. Outlook Publishing India Pvt. Ltd. https:\/\/www.outlookindia.com\/national\/indian-pharma-irregularities-hint-at-lack-of-drug-regulation-policies-and-better-oversight-news-261625 . Retrieved 05 May 2023 .   \n \n\n\u2191 47.0 47.1 Bhatt, Neha (13 January 2023). \"Inconsistent drug regulation spells danger for India\u2019s global pharma ambitions\" (in en). BMJ: p23. doi:10.1136\/bmj.p23. ISSN 1756-1833. https:\/\/www.bmj.com\/lookup\/doi\/10.1136\/bmj.p23 .   \n \n\n\u2191 Kukade, T.; Punnen, D.; Antani, M. (24 June 2022). \"Mid-Year Regulatory Update 2022: Pharmaceuticals in India\". The National Law Review XII (175). https:\/\/www.natlawreview.com\/article\/mid-year-regulatory-update-2022-pharmaceuticals-india .   \n \n\n\u2191 Health Canada (20 June 2022). \"Drug products legislation and guidelines\". Government of Canada. https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/drug-products\/legislation-guidelines.html . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Food and Drug Regulations (C.R.C., c. 870)\". Justice Laws Website. Government of Canada. 15 February 2023. https:\/\/lois.justice.gc.ca\/eng\/regulations\/C.R.C.,_c._870\/index.html . Retrieved 05 May 2023 .   \n \n\n\u2191 51.0 51.1 51.2 \"Korea Medical Device and Pharmaceutical Regulations\". Pacific Bridge Medical. 12 August 2018. https:\/\/www.pacificbridgemedical.com\/regulation\/korea-medical-device-pharmaceutical-regulations\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Pharmaceutical Affairs Act\". Korea Legislation Research Institute. 25 August 2017. https:\/\/elaw.klri.re.kr\/eng_service\/lawView.do?hseq=40196&lang=ENG . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Medical Devices Act\". Korea Legislation Research Institute. 12 July 2018. https:\/\/elaw.klri.re.kr\/eng_service\/lawView.do?hseq=48691&lang=ENG . Retrieved 05 May 2023 .   \n \n\n\u2191 54.0 54.1 Regulatory Information Task Force (2020). \"Chapter 2: Pharmaceutical Laws and Regulations\" (PDF). Pharmaceutical Administration and Regulations in Japan. Japan Pharmaceutical Manufacturers Association. pp. 15\u201356. https:\/\/www.jpma.or.jp\/english\/about\/parj\/eki4g6000000784o-att\/2020e_ch02.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 55.0 55.1 \"Japan Pharmaceutical and Medical Device Act\" (PDF). BSI Group America, Inc. November 2016. https:\/\/www.bsigroup.com\/meddev\/LocalFiles\/en-US\/Brochures\/bsi-md-japan-brochure.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 56.0 56.1 \"Good Manufacturing Practice (GMP) Resources\". International Society for Pharmaceutical Engineering, Inc. https:\/\/ispe.org\/initiatives\/regulatory-resources\/gmp . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Medicines: Good manufacturing practices\". World Health Organization. 20 November 2015. https:\/\/www.who.int\/news-room\/questions-and-answers\/item\/medicines-good-manufacturing-processes . Retrieved 05 May 2023 .   \n \n\n\u2191 Control Engineering Staff (14 July 2007). \"Regulated or not? Know good manufacturing practices (GMP)\". Control Engineering. https:\/\/www.controleng.com\/articles\/regulated-or-not-know-good-manufacturing-practices-gmp\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Good Manufacturing Practice (GMP) Guidelines\/Inspection Checklist for Cosmetics\". U.S. Food and Drug Administration. 25 February 2022. https:\/\/www.fda.gov\/cosmetics\/cosmetics-guidance-documents\/good-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Difference Between GMP and cGMP\". Pharma Specialists. 13 October 2021. https:\/\/www.pharmaspecialists.com\/2021\/10\/difference-between-gmp-and-cgmp.html#gsc.tab=0 . Retrieved 05 May 2023 .   \n \n\n\u2191 \"The Differences Between GMP and cGMP\". Moravek Blog. Moravek, Inc. January 2021. https:\/\/www.moravek.com\/the-differences-between-gmp-and-cgmp\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 62.0 62.1 U.S. Food and Drug Administration (16 November 2022). \"Current Good Manufacturing Practice (CGMP) Regulations\". https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/current-good-manufacturing-practice-cgmp-regulations . Retrieved 05 May 2023 .   \n \n\n\u2191 U.S. Food and Drug Administration (1 June 2021). \"Facts About the Current Good Manufacturing Practices (cGMPs)\". https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/facts-about-current-good-manufacturing-practices-cgmps . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements\". U.S. Food and Drug Administration. 31 January 2020. https:\/\/www.fda.gov\/food\/guidance-regulation-food-and-dietary-supplements\/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements . Retrieved 05 May 2023 .   \n \n\n\u2191 Domingo, J. (28 January 2022). \"The Complete Guide to Good Manufacturing Practices (GMP) by QVALON\". QVALON Inc. https:\/\/qvalon.com\/blog\/the-complete-guide-to-good-manufacturing-practices-gmp-by-qvalon\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Health products policy and standards - Good Manufacturing Practices\". World Health Organization. 28 September 2018. https:\/\/www.who.int\/teams\/health-product-policy-and-standards\/standards-and-specifications\/gmp . Retrieved 05 May 2023 .   \n \n\n\u2191 \"REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals)\". Electronic Components Industry Association. 2021. https:\/\/www.ecianow.org\/reach . Retrieved 05 May 2023 .   \n \n\n\u2191 Havens, R. (2 September 2021). \"Brazil Revises List of Prohibited Substances in Cosmetics\". UL Solutions. https:\/\/www.ul.com\/news\/brazil-revises-list-prohibited-substances-cosmetics . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS)\". European Commission. 2023. https:\/\/environment.ec.europa.eu\/topics\/waste-and-recycling\/rohs-directive_en . Retrieved 05 May 2023 .   \n \n\n\u2191 Department of Infrastructure, Transport, Regional Development, Communications and the Arts (2023). \"Road Vehicle Standards laws\". Australian Government. https:\/\/www.infrastructure.gov.au\/infrastructure-transport-vehicles\/vehicles\/road-vehicle-standards-laws . Retrieved 05 May 2023 .   \n \n\n\u2191 Department of Infrastructure, Transport, Regional Development, Communications and the Arts (2023). \"Australian Design Rules\". Australian Government. https:\/\/www.infrastructure.gov.au\/infrastructure-transport-vehicles\/vehicles\/vehicle-design-regulation\/australian-design-rules . Retrieved 05 May 2023 .   \n \n\n\u2191 Department of Infrastructure, Transport, Regional Development, Communications and the Arts (2023). \"Testing facilities\". Australian Government. https:\/\/www.infrastructure.gov.au\/infrastructure-transport-vehicles\/vehicles\/rvs\/testing-facilities . Retrieved 05 May 2023 .   \n \n\n\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 2. Standards and regulations affecting manufacturing labs\nTitle: LIMS Selection Guide for Manufacturing Quality Control\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: May 2023\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 21:54.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 3 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","829960d7b100216b435c1232f06318e6_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Standards_and_regulations_affecting_manufacturing_labs_Regulations_and_laws_around_the_world rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Standards_and_regulations_affecting_manufacturing_labs_Regulations_and_laws_around_the_world skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Standards and regulations affecting manufacturing labs\/Regulations and laws around the world<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h3><span class=\"mw-headline\" id=\"2.2_Regulations_and_laws_around_the_world\">2.2 Regulations and laws around the world<\/span><\/h3>\n<p>As the end of Chapter 1 highlighted, today's regulatory focus on product safety, quality, and efficacy is largely built on the past failures, injuries, and deaths that highlighted the regulatory need.<sup id=\"rdp-ebb-cite_ref-1\" class=\"reference\"><a href=\"#cite_note-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AschConsum88_2-0\" class=\"reference\"><a href=\"#cite_note-AschConsum88-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-3\" class=\"reference\"><a href=\"#cite_note-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-4\" class=\"reference\"><a href=\"#cite_note-4\">[4]<\/a><\/sup> For example, the consumption of raw milk was associated with a growing number of health issues in the mid- to late 1800s, particularly milk from unscrupulous dairy farms. In the U.S. Northeast during the 1860s, recognition was growing concerning the threat that tainted milk originating from dairy cows being singularly fed distillery byproducts had to human health. Not only was the milk generated from such cows thin and low in nutrients, but it also was adulterated with questionable substances to give it a better appearance. This resulted in many children and adults falling ill or dying from consuming the product. The efforts of Dr. Henry Coit and others in the late 1800s to develop a certification program for milk\u2014which included laboratory testing among other activities\u2014eventually helped plant the seeds for a national food and beverage safety program.<sup id=\"rdp-ebb-cite_ref-5\" class=\"reference\"><a href=\"#cite_note-5\">[5]<\/a><\/sup> By 1939, the U.S. Public Health Services had drafted the Model Milk Health Ordinance \"in order to encourage a greater uniformity of milk-control practice in the United States.\"<sup id=\"rdp-ebb-cite_ref-PHSMilk39_6-0\" class=\"reference\"><a href=\"#cite_note-PHSMilk39-6\">[6]<\/a><\/sup>\n<\/p><p>While regulation can at times be overbearing and harmful, well-crafted regulations can definitely benefit our society. This can be seen with manufacturing regulations driven on safety, quality, and efficacy principles. How those regulations are implemented around the world may differ slightly, however, which should not be surprising given the cultural, political, and functional differences across regions and nations of the world.<sup id=\"rdp-ebb-cite_ref-BuzbyFood03_7-0\" class=\"reference\"><a href=\"#cite_note-BuzbyFood03-7\">[7]<\/a><\/sup> \n<\/p><p>The following subsections examine some of the more critical regulations that apply to a wide variety of manufacturing industries, from various parts of the world.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.2.1_Food_and_beverage\">2.2.1 Food and beverage<\/span><\/h4>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Food-safety-modernization-act-fsma.png\" class=\"image wiki-link\" data-key=\"5aa8f2d01cc3ed6a02afadfecafc35a6\"><img alt=\"Food-safety-modernization-act-fsma.png\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/b2\/Food-safety-modernization-act-fsma.png\" decoding=\"async\" width=\"300\" height=\"234\" \/><\/a><\/div><p>The safety and quality of food is a high priority for most countries around the world, though how that safety and quality is regulated and legislated varies, sometimes significantly. The following subsections briefly address the primary regulations and legislation enacted in seven major countries and supranational unions around the world. (It is beyond the scope of this guide to address them all.) Similarities among the countries may be seen in their goals, but it should be noted that differences\u2014significant and nuanced\u2014exist among them all in regards to regulatory approaches to sampling, testing, risk, and importing of products.<sup id=\"rdp-ebb-cite_ref-BuzbyFood03_7-1\" class=\"reference\"><a href=\"#cite_note-BuzbyFood03-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WestGlobal18_8-0\" class=\"reference\"><a href=\"#cite_note-WestGlobal18-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GAOFoodSafety05_9-0\" class=\"reference\"><a href=\"#cite_note-GAOFoodSafety05-9\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WhitworthReport22_10-0\" class=\"reference\"><a href=\"#cite_note-WhitworthReport22-10\">[10]<\/a><\/sup> \n<\/p><p><b>2.2.1.1 Food Safety Act 1990 and Food Standards Act 1999 - <i>United Kingdom<\/i><\/b>\n<\/p><p>The <a href=\"https:\/\/en.wikipedia.org\/wiki\/Food_Safety_Act_1990\" class=\"extiw wiki-link\" title=\"wikipedia:Food Safety Act 1990\" data-key=\"64623fa858d26f24f09d8318e55a8122\">Food Safety Act of 1990<\/a> and <a href=\"https:\/\/en.wikipedia.org\/wiki\/Food_Standards_Agency\" class=\"extiw wiki-link\" title=\"wikipedia:Food Standards Agency\" data-key=\"37fc4a6b71337352fc12d00c8196bb0b\">Food Standards Act of 1999<\/a> represent the core of food safety regulation in the United Kingdom, though there are other pieces of legislation that also have an impact.<sup id=\"rdp-ebb-cite_ref-SBCFood22_11-0\" class=\"reference\"><a href=\"#cite_note-SBCFood22-11\">[11]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FSAKey22_12-0\" class=\"reference\"><a href=\"#cite_note-FSAKey22-12\">[12]<\/a><\/sup> The Food Safety Act of 1990 encourages entities to \"not include anything in food, remove anything from food, or treat food in any way which means it would be damaging to the health of people eating it\"; serve or sell food that is of a quality that \"consumers would expect\"; and ensure food is labeled, advertised, and presented clearly and truthfully.<sup id=\"rdp-ebb-cite_ref-SBCFood22_11-1\" class=\"reference\"><a href=\"#cite_note-SBCFood22-11\">[11]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FSAKey22_12-1\" class=\"reference\"><a href=\"#cite_note-FSAKey22-12\">[12]<\/a><\/sup> The Food Standards Act of 1999 later created the UK's Food Standards Agency (FSA) \"to protect public health from risks which may arise in connection with the consumption of food (including risks caused by the way in which it is produced or supplied) and otherwise to protect the interests of consumers in relation to food.\"<sup id=\"rdp-ebb-cite_ref-FSA99Sec1_13-0\" class=\"reference\"><a href=\"#cite_note-FSA99Sec1-13\">[13]<\/a><\/sup> One of the ways the FSA does this is through enforcing food safety regulation at the local level, including within food production facilities, as well as setting ingredient and nutrition labeling policy.<sup id=\"rdp-ebb-cite_ref-FSAAbout_14-0\" class=\"reference\"><a href=\"#cite_note-FSAAbout-14\">[14]<\/a><\/sup> Regulations and guidance from the FSA address not only labelling but also radioactivity monitoring, meat processing, manure management, <i>Salmonella<\/i> testing, temperature control, dairy hygiene, and more.<sup id=\"rdp-ebb-cite_ref-FSAGuidReg_15-0\" class=\"reference\"><a href=\"#cite_note-FSAGuidReg-15\">[15]<\/a><\/sup>\n<\/p><p><b>2.2.1.2 Food Safety and Standards Act of 2006 - <i>India<\/i><\/b>\n<\/p><p>This act was enacted in 2006 to both consolidate existing food-related law and to establish the Food Safety and Standards Authority of India (FSSAI), which develops regulations and standards of practice for the manufacture, storage, distribution, and packaging of food.<sup id=\"rdp-ebb-cite_ref-PRSImplement_16-0\" class=\"reference\"><a href=\"#cite_note-PRSImplement-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FSSAIFood_17-0\" class=\"reference\"><a href=\"#cite_note-FSSAIFood-17\">[17]<\/a><\/sup> However, an audit of FSSAI by the Comptroller and Auditor General of India (CAG) in December 2017 revealed some deficiencies in the FSSAI's activities, including an overall \"low quality\" of food testing laboratories in the country.<sup id=\"rdp-ebb-cite_ref-PRSImplement_16-1\" class=\"reference\"><a href=\"#cite_note-PRSImplement-16\">[16]<\/a><\/sup> Nonetheless, the FSSAI remains the primary regulatory watchdog, developing standards and guidelines for food and enforcing those standards. This includes setting limits for food additives, contaminants, pesticides, drugs, heavy metals, and more, as well as defining quality control mechanisms, accreditation requirements, sampling and analytical techniques, and more.<sup id=\"rdp-ebb-cite_ref-FSSAIFood_17-1\" class=\"reference\"><a href=\"#cite_note-FSSAIFood-17\">[17]<\/a><\/sup>\n<\/p><p><b>2.2.1.3 Food Safety Law - <i>China<\/i><\/b>\n<\/p><p>The <a href=\"https:\/\/en.wikipedia.org\/wiki\/Food_safety_in_China\" class=\"extiw wiki-link\" title=\"wikipedia:Food safety in China\" data-key=\"cc1b3179d998d1d88565a86f62832cc2\">Food Safety Law<\/a> is described as \"the fundamental law regulating food safety in China.\"<sup id=\"rdp-ebb-cite_ref-UNEPFood15_18-0\" class=\"reference\"><a href=\"#cite_note-UNEPFood15-18\">[18]<\/a><\/sup> Enacted in 2009 and revised in 2015, the Law \"builds up the basic legal framework for food safety supervision and management\" and \"introduces many new regulatory requirements,\" including \"not only general requirements applicable to food and food additives, but also specific requirements for food-related products and other product categories.\"<sup id=\"rdp-ebb-cite_ref-UNEPFood15_18-1\" class=\"reference\"><a href=\"#cite_note-UNEPFood15-18\">[18]<\/a><\/sup> Among these activities, the Law describes how food testing laboratories shall conduct their activities, from accreditation and sampling to testing and reporting.<sup id=\"rdp-ebb-cite_ref-USDAChina15_19-0\" class=\"reference\"><a href=\"#cite_note-USDAChina15-19\">[19]<\/a><\/sup>\n<\/p><p><b>2.2.1.4 Food Sanitation Act and Food Safety Basic Act - <i>Japan<\/i><\/b>\n<\/p><p>The Food Sanitation Act of 1947 and the Food Safety Basic Act of 2003 represent the most important pieces of food-related legislation in Japan, though there are others. The Food Sanitation Act was originally enacted \"to prevent sanitation hazards resulting from eating and drinking by enforcing regulations and other measures necessary from the viewpoint of public health, to ensure food safety and thereby to protect citizens' health.\"<sup id=\"rdp-ebb-cite_ref-JLTFood47_20-0\" class=\"reference\"><a href=\"#cite_note-JLTFood47-20\">[20]<\/a><\/sup> The Food Safety Basic Act recognized the effects of \"internationalization\" and changing dietary habits, as well as scientific and technological shifts in food production, as a primary driver for modernizing food safety and sustainability in the country, and it also created the Food Safety Commission of Japan.<sup id=\"rdp-ebb-cite_ref-FSCFoodSafe03_21-0\" class=\"reference\"><a href=\"#cite_note-FSCFoodSafe03-21\">[21]<\/a><\/sup> Between the two pieces of legislation, standards and specifications for food and food additives, as well as associated tools and packaging, are addressed, as are inspection standards, production standards, hygiene management, and individual food and ingredient safety.<sup id=\"rdp-ebb-cite_ref-BMFoodJapan18_22-0\" class=\"reference\"><a href=\"#cite_note-BMFoodJapan18-22\">[22]<\/a><\/sup>\n<\/p><p><b>2.2.1.5 Food Safety Modernization Act (FSMA) and other acts - <i>United States<\/i><\/b>\n<\/p><p>The <a href=\"https:\/\/en.wikipedia.org\/wiki\/FDA_Food_Safety_Modernization_Act\" class=\"extiw wiki-link\" title=\"wikipedia:FDA Food Safety Modernization Act\" data-key=\"34e91ef01e8fb77d1dc37a4987226bb1\">Food Safety Modernization Act<\/a> of the United States was signed into law in January 2011, giving the US Food and Drug Administration (FDA) more regulatory authority to address the way food is grown, harvested, and processed.<sup id=\"rdp-ebb-cite_ref-WeinrothHist18_23-0\" class=\"reference\"><a href=\"#cite_note-WeinrothHist18-23\">[23]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FDAFood22_24-0\" class=\"reference\"><a href=\"#cite_note-FDAFood22-24\">[24]<\/a><\/sup> It has been described by the FDA as \"the most sweeping reform of our food safety laws in more than 70 years.\"<sup id=\"rdp-ebb-cite_ref-FDAFood22_24-1\" class=\"reference\"><a href=\"#cite_note-FDAFood22-24\">[24]<\/a><\/sup> The FSMA, at its base, has five key aspects, addressing preventive controls, inspection and compliance, safety of food imports, mandatory recall response, and food partnership enhancement.<sup id=\"rdp-ebb-cite_ref-FDAFood22_24-2\" class=\"reference\"><a href=\"#cite_note-FDAFood22-24\">[24]<\/a><\/sup> However, FSMA continues to evolve, with additional rules getting added since its enactment, including rules about record management, good manufacturing practice (GMP) for human food and animal feed, and laboratory accreditation (referred to as the <a href=\"https:\/\/www.limswiki.org\/index.php\/LII:FDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods:_Considerations_for_Labs_and_Informatics_Vendors\" title=\"LII:FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors\" class=\"wiki-link\" data-key=\"db3a91773a3d971ad1c5d4df3a7cfd32\">LAAF Rule<\/a>).<sup id=\"rdp-ebb-cite_ref-FDAFSMA22_25-0\" class=\"reference\"><a href=\"#cite_note-FDAFSMA22-25\">[25]<\/a><\/sup>\n<\/p><p>Another important regulatory body in the US is the Food Safety and Inspection Service (FSIS), which is overseen by the US Department of Agriculture (USDA). The FSIS and its authority to regulate are derived from three different acts: the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957, and the Egg Products Inspection Act of 1970.<sup id=\"rdp-ebb-cite_ref-USDAOurHist18_26-0\" class=\"reference\"><a href=\"#cite_note-USDAOurHist18-26\">[26]<\/a><\/sup> The FSIS has developed its own regulatory requirements for meat, poultry, and egg products, including for inspections, imports and exports, labeling, and laboratory testing.<sup id=\"rdp-ebb-cite_ref-9CFR412_27-0\" class=\"reference\"><a href=\"#cite_note-9CFR412-27\">[27]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FSISFedReg_28-0\" class=\"reference\"><a href=\"#cite_note-FSISFedReg-28\">[28]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NALFoodSafe_29-0\" class=\"reference\"><a href=\"#cite_note-NALFoodSafe-29\">[29]<\/a><\/sup>\n<\/p><p><b>2.2.1.6 General Food Law Regulation (GFLR) - <i>European Union<\/i><\/b>\nThe GFLR was enacted across the European Union in 2002 as part of Regulation (EC) No 178\/2002, and it is described as \"the foundation of food and feed law\" for the EU.<sup id=\"rdp-ebb-cite_ref-EUGeneral_30-0\" class=\"reference\"><a href=\"#cite_note-EUGeneral-30\">[30]<\/a><\/sup> Along with setting requirements and procedures for food and feed safety, the GFLR also mandated the creation of the European Food Safety Authority (EFSA), an independent body assigned to developing sound scientific advice about and providing support towards the goals of food, beverage, and feed safety in the EU.<sup id=\"rdp-ebb-cite_ref-WeinrothHist18_23-1\" class=\"reference\"><a href=\"#cite_note-WeinrothHist18-23\">[23]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EUGeneral_30-1\" class=\"reference\"><a href=\"#cite_note-EUGeneral-30\">[30]<\/a><\/sup> As such, the EFSA develops broad and sector-specific guidance<sup id=\"rdp-ebb-cite_ref-EFSAGuidance_31-0\" class=\"reference\"><a href=\"#cite_note-EFSAGuidance-31\">[31]<\/a><\/sup>, as well as other rules related to scientific assessment of food safety matters, e.g., Regulation (EC) No 2073\/2005 on microbiological criteria for foodstuffs.<sup id=\"rdp-ebb-cite_ref-EU2073-2005_32-0\" class=\"reference\"><a href=\"#cite_note-EU2073-2005-32\">[32]<\/a><\/sup> The EFSA also develops food classification standardization tools such as the Standard Sample Description (SSD2) data model, to better ensure an appropriate \"format for describing food and feed samples and analytical results that is used by EFSA\u2019s data providers.\"<sup id=\"rdp-ebb-cite_ref-EFSAFoodClass_33-0\" class=\"reference\"><a href=\"#cite_note-EFSAFoodClass-33\">[33]<\/a><\/sup>\n<\/p><p><b>2.2.1.7 Safe Food for Canadians Act (SFCA) - <i>Canada<\/i><\/b>\n<\/p><p>In November 2012, the SFCA was enacted to place regulatory \"focus on prevention to ensure a food that is imported, exported or shipped from one province to another, is manufactured, stored, packaged and labelled in a way that does not present a risk of contamination.\"<sup id=\"rdp-ebb-cite_ref-ManitobaSafe_34-0\" class=\"reference\"><a href=\"#cite_note-ManitobaSafe-34\">[34]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-JLWSafeFood19_35-0\" class=\"reference\"><a href=\"#cite_note-JLWSafeFood19-35\">[35]<\/a><\/sup> Though Canadian Food Inspection Agency (CFIA) enforcement of the SFCA's regulations didn't start until January 2019<sup id=\"rdp-ebb-cite_ref-ManitobaSafe_34-1\" class=\"reference\"><a href=\"#cite_note-ManitobaSafe-34\">[34]<\/a><\/sup>, the consolidation of 14 sets of existing food regulations by the SFCA has managed to improve consistency, reduce administrative burden, and enable food business innovation.<sup id=\"rdp-ebb-cite_ref-GoCUnder18_36-0\" class=\"reference\"><a href=\"#cite_note-GoCUnder18-36\">[36]<\/a><\/sup> An interpretive guide published by the CFIA, <i>Understanding the Safe Food for Canadians Regulations: A handbook for food businesses<\/i>, summarizes and explains some of the nuances of the SFCA and its 16 parts on matters such as trade, licensing, preventive controls, packaging and labeling, and traceability.<sup id=\"rdp-ebb-cite_ref-GoCUnder18_36-1\" class=\"reference\"><a href=\"#cite_note-GoCUnder18-36\">[36]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.2.2_Materials\">2.2.2 Materials<\/span><\/h4>\n<div class=\"floatleft\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Assessing_prototype_reference_material_for_testing_emissions_of_VOCs_(5940985174).jpg\" class=\"image wiki-link\" data-key=\"66ea46f7ae0f7c16d1f4d79fc5f4b7d8\"><img alt=\"Assessing prototype reference material for testing emissions of VOCs (5940985174).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/a\/a4\/Assessing_prototype_reference_material_for_testing_emissions_of_VOCs_%285940985174%29.jpg\" decoding=\"async\" width=\"330\" height=\"302\" \/><\/a><\/div>\n<p>Like materials standards, there are too many materials regulations to list for the given scope of this guide. However, several different examples are given below of materials-related regulations found in various parts of the world.\n<\/p><p><b>2.2.2.1 21 CFR Part 175 and 176 - <i>United States<\/i><\/b>\n<\/p><p>These two regulations from the U.S. Code of Federal Regulations system relate specifically to the materials used to package food. (While the food and beverage industry is the recipient and end user of such materials, the materials researcher and manufacturer is responsible, in part, for developing and producing materials that meet such regulations.) Part 175 dictates what substances can be used as components of adhesives and coatings in food packaging materials<sup id=\"rdp-ebb-cite_ref-ECFR21Part175_37-0\" class=\"reference\"><a href=\"#cite_note-ECFR21Part175-37\">[37]<\/a><\/sup>, and Part 176 addresses what substances can be used as components of paper and paperboard in food packaging materials.<sup id=\"rdp-ebb-cite_ref-ECFR21Part176_38-0\" class=\"reference\"><a href=\"#cite_note-ECFR21Part176-38\">[38]<\/a><\/sup>\n<\/p><p><b>2.2.2.2 Building Standard Law - <i>Japan<\/i><\/b>\n<\/p><p>Japan's Building Standard Law, broadly speaking, states a minimum set of standards that must be followed concerning the construction of buildings in the country, in order to protect the health and property of those using those buildings. Given the country's infrastructure is affected by snow accumulation, earthquakes, and tsunamis, a modern approach to building regulation was required in 1950. One section of the law addresses the quality of materials used in building construction, particularly in important sections of the home such as the foundation, load-bearing walls, columns, and more. The regulation mandates that such materials must conform to the Japanese Industrial Standard or Japanese Agriculture Standard, or that they be specifically approved by the Minister. This means manufacturers of structural steel, high-strength bolts, concrete, wood-based composite panels, membrane materials, and more are largely beholden to those standards throughout the manufacturing process.<sup id=\"rdp-ebb-cite_ref-TomohiroIntro13_39-0\" class=\"reference\"><a href=\"#cite_note-TomohiroIntro13-39\">[39]<\/a><\/sup>\n<\/p><p><b>2.2.2.3 The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - <i>United Kingdom<\/i><\/b>\n<\/p><p>In 1988, the U.K. made into law The Furniture and Furnishings (Fire) (Safety) Regulations, which \"were introduced to help reduce the risks of injury or loss of life through fires in the home spread by upholstered furniture.\"<sup id=\"rdp-ebb-cite_ref-OPSSUpdat19_40-0\" class=\"reference\"><a href=\"#cite_note-OPSSUpdat19-40\">[40]<\/a><\/sup> The regulations set out general testing requirements for foam fillings, non-foam fillings, composite fillings, and cover materials, requiring that they pass various material and combustion requirements.<sup id=\"rdp-ebb-cite_ref-BCNewUphol22_41-0\" class=\"reference\"><a href=\"#cite_note-BCNewUphol22-41\">[41]<\/a><\/sup> Various updates have been made to the regulations over time. In 2019, the government, noting \"growing evidence linking the specific flame-retardant chemicals most often used in furniture to serious long-term health impacts,\" acknowledged that updates to regulations on the materials used in furniture making were required, which would in turn further dictate manufacturing processes.\n<\/p><p><b>2.2.2.4 National Environment Protection (Used Packaging Materials) Measure 2011 - <i>Australia<\/i><\/b>\n<\/p><p>In September 2011, Australia's National Environment Protection Council made law the National Environment Protection (Used Packaging Materials) Measure 2011. Signatories of the Covenant agreed to \"a voluntary system of industry self regulation\" to better ensure \"improved environmental outcomes\" in regards to packaging material use and re-use.<sup id=\"rdp-ebb-cite_ref-FRLNation11_42-0\" class=\"reference\"><a href=\"#cite_note-FRLNation11-42\">[42]<\/a><\/sup> However, a 2021 review found that the regulation was lacking in several areas, including with monitoring and enforcement. A December 2022 response by the government agreed, noting, \"[l]ack of compliance monitoring and enforcement activity has undermined the effectiveness of, and confidence in, the mandatory co-regulatory arrangement and enabled some businesses to avoid their obligations.\" Updates to the regulations are expected by 2025, \"to ensure that all packaging available in Australia is designed to be recovered, reused, recycled and reprocessed safely in line with circular economy principles. Reforming the regulation of packaging in Australia presents a significant opportunity to improve the way our packaging is designed ...\"<sup id=\"rdp-ebb-cite_ref-DCCEEWAustr_43-0\" class=\"reference\"><a href=\"#cite_note-DCCEEWAustr-43\">[43]<\/a><\/sup> As this language suggests, such regulatory changes, should they come, will further dictate the materials designed and used in manufacturing processes in the country.\n<\/p><p><b>2.2.2.5 Surface Coating Materials Regulations (SOR\/2016-193) - <i>Canada<\/i><\/b>\n<\/p><p>Enacted in 2016, these regulations\u2014enabled by Canada's Consumer Product Safety Act\u2014dictate the amount of lead and mercury allowed in surface coating materials, stickers, and films under certain circumstances. The testing for those must be done by manufacturers (or their third-party labs) \"in accordance with a method that conforms to good laboratory practices.\"<sup id=\"rdp-ebb-cite_ref-JLWSurface22_44-0\" class=\"reference\"><a href=\"#cite_note-JLWSurface22-44\">[44]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.2.3_Pharmaceutical_and_medical_devices\">2.2.3 Pharmaceutical and medical devices<\/span><\/h4>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Generic_Drug_Research_(5896)_(8493711422).jpg\" class=\"image wiki-link\" data-key=\"552376d1b375e07839f9dc00b7d45904\"><img alt=\"Generic Drug Research (5896) (8493711422).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/c\/c9\/Generic_Drug_Research_%285896%29_%288493711422%29.jpg\" decoding=\"async\" width=\"340\" height=\"226\" \/><\/a><\/div><p>As was similarly noted in the section about pharmaceutical and medical device standards, regulations in this industry are vital for ensuring the safety of consumers and the efficacy of the drugs and devices they use, and they are typically present as some of the most rigorous regulations for the broad world of manufacturing. That said, as serious as pharmaceutical regulation can be, governments can often be slow to act with their regulatory duties<sup id=\"rdp-ebb-cite_ref-MPWGSRegul11_45-0\" class=\"reference\"><a href=\"#cite_note-MPWGSRegul11-45\">[45]<\/a><\/sup> or have complex governance structures and difficult-to-enforce rules.<sup id=\"rdp-ebb-cite_ref-BasakIndian23_46-0\" class=\"reference\"><a href=\"#cite_note-BasakIndian23-46\">[46]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BhattIncon23_47-0\" class=\"reference\"><a href=\"#cite_note-BhattIncon23-47\">[47]<\/a><\/sup> As these regulatory bodies and their regulations improve, manufacturers of pharmaceuticals and medical devices find themselves needing to be even more efficient in their activities and focused on good manufacturing practices.\n<\/p><p>The following represent examples of pharmaceutical and medical device regulation around the world. Note that the discussion of GMP and cGMP is discussed further in the next section.\n<\/p><p><b>2.2.3.1 Current Good Manufacturing Practice (cGMP) regulations - <i>United States and other countries<\/i><\/b>\n<\/p><p>For more on this, see the next section on other industries and regulations.\n<\/p><p><b>2.2.3.2 Drugs and Cosmetics Act of 1940 - <i>India<\/i><\/b>\n<\/p><p>This act represents the primary regulatory control over the manufacture of pharmaceuticals and cosmetics in India. The act \"creates a web of regulatory authorities to govern the process at both the central and the state levels.\"<sup id=\"rdp-ebb-cite_ref-BasakIndian23_46-1\" class=\"reference\"><a href=\"#cite_note-BasakIndian23-46\">[46]<\/a><\/sup> Like other pharmaceutical regulations in other countries, the act attempts to ensure that drugs, cosmetics, medical devices, and diagnostic devices sold in India are safe, standardized to a certain quality, and effective at what they are said to do. Public health activists, lawyers, and specialized agencies such as the WHO, however, have criticized India's regulatory efforts in recent years for not keeping up with the rapidly growing industry while exhibiting poor transparency, unnecessary complexity, and insufficient statutory backing (as seen with the Central Drugs Standard Control Organisation or CDSCO).<sup id=\"rdp-ebb-cite_ref-BasakIndian23_46-2\" class=\"reference\"><a href=\"#cite_note-BasakIndian23-46\">[46]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BhattIncon23_47-1\" class=\"reference\"><a href=\"#cite_note-BhattIncon23-47\">[47]<\/a><\/sup> The country has been attempting to reform the regulatory system by, for example, updating the Indian Pharmacopoeia and the Drugs and Cosmetics Act with more modern, relevant information and improved labeling mechanisms for tracking and tracing drugs.<sup id=\"rdp-ebb-cite_ref-48\" class=\"reference\"><a href=\"#cite_note-48\">[48]<\/a><\/sup>\n<\/p><p><b>2.2.3.3 Food and Drugs Act - <i>Canada<\/i><\/b>\n<\/p><p>Canada's Food and Drugs Act enables its Food and Drug Regulations, which, among other things, helps to \"ensure the pharmaceutical drugs offered for sale in Canada are safe, effective and of high quality.\"<sup id=\"rdp-ebb-cite_ref-HCDrug22_49-0\" class=\"reference\"><a href=\"#cite_note-HCDrug22-49\">[49]<\/a><\/sup> Part C of the regulations addresses drugs in a broad sense, with Division 2 of that part regulating manufacturing controls, quality testing, and records management.<sup id=\"rdp-ebb-cite_ref-JLWFoodDrug23_50-0\" class=\"reference\"><a href=\"#cite_note-JLWFoodDrug23-50\">[50]<\/a><\/sup> These regulations are overseen and updated by Health Canada \"through a combination of scientific review, monitoring, compliance, and enforcement activities.\"<sup id=\"rdp-ebb-cite_ref-MPWGSRegul11_45-1\" class=\"reference\"><a href=\"#cite_note-MPWGSRegul11-45\">[45]<\/a><\/sup>\n<\/p><p><b>2.2.3.4 Pharmaceutical Affairs Act (PAA) and Medical Devices Act (MDA) - <i>South Korea<\/i><\/b>\n<\/p><p>Overseen by the Ministry of Food and Drug Safety (MFDS), these acts help ensure safer and effective pharmaceuticals and medical devices to the people of South Korea. The country's PAA classifies pharmaceuticals as either pharmaceutical ingredients or drug products, which in turn are broken down into new drugs, pharmaceuticals requiring specific data submissions, and generic drugs.<sup id=\"rdp-ebb-cite_ref-PBMKorea18_51-0\" class=\"reference\"><a href=\"#cite_note-PBMKorea18-51\">[51]<\/a><\/sup> The PAA's goal is described as being \"to prescribe matters necessary to deal with pharmaceutical affairs smoothly, thereby contributing to the improvement of the national public health.\"<sup id=\"rdp-ebb-cite_ref-KLRIPharm17_52-0\" class=\"reference\"><a href=\"#cite_note-KLRIPharm17-52\">[52]<\/a><\/sup> The MDA's goal is \"to promote the efficient management of medical devices and further contribute to the improvement of public health by providing for matters concerning the manufacturing, import, distribution, etc. of medical devices.\"<sup id=\"rdp-ebb-cite_ref-KLRIMedDev18_53-0\" class=\"reference\"><a href=\"#cite_note-KLRIMedDev18-53\">[53]<\/a><\/sup> Along with managing the regulations from these acts, the MFDS is also responsible for setting the manufacturing standards and specifications for pharmaceuticals, monitoring certain pre- and post-manufacturing procedures, enforcing good manufacturing practice, reinforcing safety controls, and more.<sup id=\"rdp-ebb-cite_ref-PBMKorea18_51-1\" class=\"reference\"><a href=\"#cite_note-PBMKorea18-51\">[51]<\/a><\/sup>\n<\/p><p><b>2.2.3.5 Pharmaceutical and Medical Device Act (PMD Act) - <i>Japan<\/i><\/b>\n<\/p><p>The PMD Act represents one of the primary pieces of pharmaceutical and medical device regulation in Japan. The PMD Act replaced Japan's Pharmaceutical Affairs Law in November 2014, with the primary goal of using regulation to improve public health by assuring the quality, safety, and efficacy of pharmaceuticals, medical devices, and cosmetics, as well as preventing the expansion of activities harmful to those efforts. Under the PMD Act, manufacturers are expected to demonstrate how their products conform to Japan's regulations and how their operations are guided by a well-defined QMS.<sup id=\"rdp-ebb-cite_ref-JPMAPharm20_54-0\" class=\"reference\"><a href=\"#cite_note-JPMAPharm20-54\">[54]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BSIJapan16_55-0\" class=\"reference\"><a href=\"#cite_note-BSIJapan16-55\">[55]<\/a><\/sup> The act has multiple chapters addressing the manufacturing of drugs, \"quasi-drugs,\" cosmetics, cellular and tissue-based products, medical devices, and <i>in vitro<\/i> diagnostic devices, as well as separate chapters on the safety of and standards applicable to drugs.<sup id=\"rdp-ebb-cite_ref-JPMAPharm20_54-1\" class=\"reference\"><a href=\"#cite_note-JPMAPharm20-54\">[54]<\/a><\/sup> In regards to manufacturers of medical devices, they should turn to several sets of standards published by Japan's Ministry of Health, Labour and Welfare (MHLW)\u2014MO No. 169 \u2013 <i>Standards for Manufacturing Control and Quality Control for Medical Devices and In Vitro Diagnostic Reagents<\/i> and MO No. 135 \u2013 <i>Standards for Good Vigilance Practice (GVP)<\/i>\u2014in order to better comply with the PMD Act.<sup id=\"rdp-ebb-cite_ref-BSIJapan16_55-1\" class=\"reference\"><a href=\"#cite_note-BSIJapan16-55\">[55]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.3.4_Other_industries_and_regulations\">2.3.4 Other industries and regulations<\/span><\/h4>\n<div class=\"floatleft\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:GMP_GOOD_MANUFACTURING_PRACTICE.png\" class=\"image wiki-link\" data-key=\"1f4384d6e188fba86d681774b43b0d28\"><img alt=\"GMP GOOD MANUFACTURING PRACTICE.png\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/8\/80\/GMP_GOOD_MANUFACTURING_PRACTICE.png\" decoding=\"async\" width=\"220\" height=\"220\" \/><\/a><\/div><p>Like standards, manufacturing regulations exist beyond industries like the food and beverage, materials, and pharmaceutical industries. From electronics and automotive parts to cosmetics and chemicals, governments around the world place restrictions on and recommendations for testing a variety of manufactured goods. What follows are a few examples of regulations on other industries from various parts of the world.\n<\/p><p><b>2.3.4.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP) - <i>United States and other countries<\/i><\/b>\n<\/p><p>As a broad concept, <a href=\"https:\/\/www.limswiki.org\/index.php\/Good_manufacturing_practice\" title=\"Good manufacturing practice\" class=\"wiki-link\" data-key=\"50b520c825b1702be310362c66e0343f\">good manufacturing practice<\/a> or GMP is an organized set of standards and guidelines that allow manufacturers of most any product to better ensure their products are consistently produced and packaged to a consistent level of quality. GMP tends to cover most every step of production, from planning recipes and choosing starting materials to training personnel and documenting processes.<sup id=\"rdp-ebb-cite_ref-ISPEGMP_56-0\" class=\"reference\"><a href=\"#cite_note-ISPEGMP-56\">[56]<\/a><\/sup> The concept of GMP is often spoken of in terms of pharmaceutical and medical device manufacturing<sup id=\"rdp-ebb-cite_ref-PBMKorea18_51-2\" class=\"reference\"><a href=\"#cite_note-PBMKorea18-51\">[51]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ISPEGMP_56-1\" class=\"reference\"><a href=\"#cite_note-ISPEGMP-56\">[56]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WHOMedicines15_57-0\" class=\"reference\"><a href=\"#cite_note-WHOMedicines15-57\">[57]<\/a><\/sup>, though it is applicable to most any other production industry.<sup id=\"rdp-ebb-cite_ref-CEReg07_58-0\" class=\"reference\"><a href=\"#cite_note-CEReg07-58\">[58]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FDAGMPCosm22_59-0\" class=\"reference\"><a href=\"#cite_note-FDAGMPCosm22-59\">[59]<\/a><\/sup>\n<\/p><p>Closely related is the term \"current good manufacturing practice\" or cGMP. Both \"GMP\" and \"cGMP\" are largely interchangeable, though the latter is preferred in most regulatory language of the United States. A more nuanced take says that cGMP essentially represents the newest, most updated technologies implemented towards the goals of meeting GMP requirements.<sup id=\"rdp-ebb-cite_ref-PSDiff21_60-0\" class=\"reference\"><a href=\"#cite_note-PSDiff21-60\">[60]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MoravekTheDiff_61-0\" class=\"reference\"><a href=\"#cite_note-MoravekTheDiff-61\">[61]<\/a><\/sup> \n<\/p><p>In the United States, cGMP\u2014in the context of pharmaceuticals\u2014is enshrined in numerous sections of Title 21 of the Code of Federal Regulations, including \"in parts 1-99, 200-299, 300-499, 600-799, and 800-1299.\"<sup id=\"rdp-ebb-cite_ref-FDAcGMP22_62-0\" class=\"reference\"><a href=\"#cite_note-FDAcGMP22-62\">[62]<\/a><\/sup> The FDA describes these regulations as containing \"minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.\"<sup id=\"rdp-ebb-cite_ref-FDAcGMP22_62-1\" class=\"reference\"><a href=\"#cite_note-FDAcGMP22-62\">[62]<\/a><\/sup> It also states safety, efficacy, and labeling requirements for manufactured drugs. These regulations require careful attention by manufacturers, lest they face seizure of their products, legal injunction, and criminal cases.<sup id=\"rdp-ebb-cite_ref-FDAFactsAb21_63-0\" class=\"reference\"><a href=\"#cite_note-FDAFactsAb21-63\">[63]<\/a><\/sup>\n<\/p><p>In the context of food, cGMP principles were first introduced in the U.S. in 1969 as 21 CFR Part 110, though the concept of cGMP was modernized in 2015, in 21 CFR Part 117. This led to not only broad food- and beverage-based cGMPs but also cGMPs specific to a type of ingestible, including dietary supplements, infant formula, low-acid canned food, and bottled water.<sup id=\"rdp-ebb-cite_ref-FDACurrentGood20_64-0\" class=\"reference\"><a href=\"#cite_note-FDACurrentGood20-64\">[64]<\/a><\/sup> \n<\/p><p>GMP and cGMP contexts also exist for other manufacturing industries outside of pharmaceuticals and food, including automotive parts, medical devices, clothing, and more.<sup id=\"rdp-ebb-cite_ref-DomingoTheComp22_65-0\" class=\"reference\"><a href=\"#cite_note-DomingoTheComp22-65\">[65]<\/a><\/sup> Additionally, these concepts are not limited to the U.S. For example, the World Health Organization has its own GMP\/cGMP guidelines for pharmaceuticals and biological medicines, with more than 100 countries reportedly incorporating those guidelines into their national medicine regulations.<sup id=\"rdp-ebb-cite_ref-WHOGMP18_66-0\" class=\"reference\"><a href=\"#cite_note-WHOGMP18-66\">[66]<\/a><\/sup>\n<\/p><p><b>2.3.4.2 Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation - <i>European Union<\/i><\/b>\n<\/p><p>For the E.U.'s chemical manufacturers and the other manufacturing industries depending on those chemicals, REACH represents one of the most expansive and complicated pieces of regulation in the E.U. Affecting potentially more than 140,000 substances, manufacturers of those substances are now largely responsible for identifying hazards, identifying mitigation methods for those hazards, and managing associated risks. Of particular note are \"substances of very high concern\" (SVHCs) and how they are authorized and restricted. This regulations means manufacturers must pay closer attention to what substances get put into their products and report on SVHCs making up more than 0.1 percent (by weight) of the product. These regulations may also mean the manufacturer may need to redesign their products with new substances.<sup id=\"rdp-ebb-cite_ref-ECIAREACH21_67-0\" class=\"reference\"><a href=\"#cite_note-ECIAREACH21-67\">[67]<\/a><\/sup>\n<\/p><p><b>2.3.4.3 Resolu\u00e7\u00e3o de diretoria colegiada - RDC n\u00ba 529 - <i>Brazil<\/i><\/b>\n<\/p><p>This Brazilian resolution, effective August 2021, revised the country's List of Prohibited Substances in Personal Hygiene, Cosmetics and Perfume Products to include additional substances. While it's not clear what original legislation houses that list, this list makes clear that manufacturers of personal hygiene, cosmetic, and perfume products have to be mindful of the ingredients they use in their manufacturing processes.<sup id=\"rdp-ebb-cite_ref-HavensBrazil21_68-0\" class=\"reference\"><a href=\"#cite_note-HavensBrazil21-68\">[68]<\/a><\/sup>\n<\/p><p><b>2.3.4.4 Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive - <i>European Union<\/i><\/b>\n<\/p><p>The E.U. uses the RoHS Directive as a means towards restricting the use of specific hazardous materials in the manufacture of electrical and electronic equipment (EEE), namely \"lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP).\"<sup id=\"rdp-ebb-cite_ref-ECRestrict_69-0\" class=\"reference\"><a href=\"#cite_note-ECRestrict-69\">[69]<\/a><\/sup> By extension, the E.U. is encouraging safer alternatives for the manufacturing of EEE and fewer hazardous substances making their way into ecosystems from waste streams.\n<\/p><p><b>2.3.4.5 Road Vehicle Standards (RVS) legislation - <i>Australia<\/i><\/b>\n<\/p><p>Coming into effect in July 2021 as a replacement to the Motor Vehicle Standards Act 1989, the RVS legislation brought regulation of road vehicle manufacturing into the twenty-first century, with updates to recalls, model reports, testing, and component type approvals. These regulations are backed by the Australian Design Rules (ADRs), which are national standards for vehicle safety.<sup id=\"rdp-ebb-cite_ref-DITRDCARoad23_70-0\" class=\"reference\"><a href=\"#cite_note-DITRDCARoad23-70\">[70]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DITRDCAusDes23_71-0\" class=\"reference\"><a href=\"#cite_note-DITRDCAusDes23-71\">[71]<\/a><\/sup> Approved testing facilities are required to test that vehicles and their components are in compliance with ADRs and other relevant standards.<sup id=\"rdp-ebb-cite_ref-DITRDCTesting23_72-0\" class=\"reference\"><a href=\"#cite_note-DITRDCTesting23-72\">[72]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-1\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Center for Policy Alternatives at the Massachusetts Institute of Technology (1980). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=VadeKZOzcmwC&pg=PA1\" target=\"_blank\"><i>Benefits of Environmental, Health, and Safety Regulation<\/i><\/a>. U.S. Government Printing Office. pp. 100<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=VadeKZOzcmwC&pg=PA1\" target=\"_blank\">https:\/\/books.google.com\/books?id=VadeKZOzcmwC&pg=PA1<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Benefits+of+Environmental%2C+Health%2C+and+Safety+Regulation&rft.aulast=Center+for+Policy+Alternatives+at+the+Massachusetts+Institute+of+Technology&rft.au=Center+for+Policy+Alternatives+at+the+Massachusetts+Institute+of+Technology&rft.date=1980&rft.pages=pp.%26nbsp%3B100&rft.pub=U.S.+Government+Printing+Office&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DVadeKZOzcmwC%26pg%3DPA1&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AschConsum88-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AschConsum88_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Asch, Peter (1988). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=Pi_nCwAAQBAJ&pg=PA1\" target=\"_blank\"><i>Consumer safety regulation: putting a price on life and limb<\/i><\/a>. New York: Oxford University Press. pp. 3\u201314. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-19-504972-5<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=Pi_nCwAAQBAJ&pg=PA1\" target=\"_blank\">https:\/\/books.google.com\/books?id=Pi_nCwAAQBAJ&pg=PA1<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Consumer+safety+regulation%3A+putting+a+price+on+life+and+limb&rft.aulast=Asch&rft.aufirst=Peter&rft.au=Asch%2C%26%2332%3BPeter&rft.date=1988&rft.pages=pp.%26nbsp%3B3%E2%80%9314&rft.place=New+York&rft.pub=Oxford+University+Press&rft.isbn=978-0-19-504972-5&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DPi_nCwAAQBAJ%26pg%3DPA1&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-3\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Dwyer, Tom (1991). <i>Life and death at work: industrial accidents as a case of socially produced error<\/i>. Plenum studies in work and industry. New York: Plenum Press. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-306-43949-0.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Life+and+death+at+work%3A+industrial+accidents+as+a+case+of+socially+produced+error&rft.aulast=Dwyer&rft.aufirst=Tom&rft.au=Dwyer%2C%26%2332%3BTom&rft.date=1991&rft.series=Plenum+studies+in+work+and+industry&rft.place=New+York&rft.pub=Plenum+Press&rft.isbn=978-0-306-43949-0&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-4\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">CoVan, James (1995). <i>Safety engineering<\/i>. New dimensions in engineering. New York: Wiley. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-471-55612-1.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Safety+engineering&rft.aulast=CoVan&rft.aufirst=James&rft.au=CoVan%2C%26%2332%3BJames&rft.date=1995&rft.series=New+dimensions+in+engineering&rft.place=New+York&rft.pub=Wiley&rft.isbn=978-0-471-55612-1&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-5\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Lytton, Timothy D. (2019). \"Chapter 2: The Gospel of Clean Milk\". <i>Outbreak: foodborne illness and the struggle for food safety<\/i>. Chicago ; London: The University of Chicago Press. pp. 24-64. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-226-61154-9.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+2%3A+The+Gospel+of+Clean+Milk&rft.atitle=Outbreak%3A+foodborne+illness+and+the+struggle+for+food+safety&rft.aulast=Lytton&rft.aufirst=Timothy+D.&rft.au=Lytton%2C%26%2332%3BTimothy+D.&rft.date=2019&rft.pages=pp.%26nbsp%3B24-64&rft.place=Chicago+%3B+London&rft.pub=The+University+of+Chicago+Press&rft.isbn=978-0-226-61154-9&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PHSMilk39-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PHSMilk39_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">U.S. Public Health Service (1939). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/resource.nlm.nih.gov\/101528318\" target=\"_blank\">\"Milk ordinance and code: Recommended by the United States Public Health Service, 1939\"<\/a>. U.S. Government Printing Office<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/resource.nlm.nih.gov\/101528318\" target=\"_blank\">http:\/\/resource.nlm.nih.gov\/101528318<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Milk+ordinance+and+code%3A+Recommended+by+the+United+States+Public+Health+Service%2C+1939&rft.atitle=&rft.aulast=U.S.+Public+Health+Service&rft.au=U.S.+Public+Health+Service&rft.date=1939&rft.pub=U.S.+Government+Printing+Office&rft_id=http%3A%2F%2Fresource.nlm.nih.gov%2F101528318&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BuzbyFood03-7\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BuzbyFood03_7-0\">7.0<\/a><\/sup> <sup><a href=\"#cite_ref-BuzbyFood03_7-1\">7.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Buzby, J.C.; Mitchell, L. (1 November 2003). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ers.usda.gov\/amber-waves\/2003\/november\/food-safety-and-trade-regulations-risks-and-reconciliation\/\" target=\"_blank\">\"Food Safety and Trade: Regulations, Risks, and Reconciliation\"<\/a>. <i>Amber Waves<\/i>. U.S. Department of Agriculture, Economic Research Service<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.ers.usda.gov\/amber-waves\/2003\/november\/food-safety-and-trade-regulations-risks-and-reconciliation\/\" target=\"_blank\">https:\/\/www.ers.usda.gov\/amber-waves\/2003\/november\/food-safety-and-trade-regulations-risks-and-reconciliation\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Food+Safety+and+Trade%3A+Regulations%2C+Risks%2C+and+Reconciliation&rft.atitle=Amber+Waves&rft.aulast=Buzby%2C+J.C.%3B+Mitchell%2C+L.&rft.au=Buzby%2C+J.C.%3B+Mitchell%2C+L.&rft.date=1+November+2003&rft.pub=U.S.+Department+of+Agriculture%2C+Economic+Research+Service&rft_id=https%3A%2F%2Fwww.ers.usda.gov%2Famber-waves%2F2003%2Fnovember%2Ffood-safety-and-trade-regulations-risks-and-reconciliation%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WestGlobal18-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WestGlobal18_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">West, D.M.; Lansang, C. (10 July 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.brookings.edu\/research\/global-manufacturing-scorecard-how-the-us-compares-to-18-other-nations\/\" target=\"_blank\">\"Global manufacturing scorecard: How the US compares to 18 other nations\"<\/a>. <i>Brookings<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.brookings.edu\/research\/global-manufacturing-scorecard-how-the-us-compares-to-18-other-nations\/\" target=\"_blank\">https:\/\/www.brookings.edu\/research\/global-manufacturing-scorecard-how-the-us-compares-to-18-other-nations\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Global+manufacturing+scorecard%3A+How+the+US+compares+to+18+other+nations&rft.atitle=Brookings&rft.aulast=West%2C+D.M.%3B+Lansang%2C+C.&rft.au=West%2C+D.M.%3B+Lansang%2C+C.&rft.date=10+July+2018&rft_id=https%3A%2F%2Fwww.brookings.edu%2Fresearch%2Fglobal-manufacturing-scorecard-how-the-us-compares-to-18-other-nations%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GAOFoodSafety05-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GAOFoodSafety05_9-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">U.S. Government Accountability Office (February 2005). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gao.gov\/products\/gao-05-212\" target=\"_blank\">\"Food Safety: Experiences of Seven Countries in Consolidating Their Food Safety Systems\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.gao.gov\/products\/gao-05-212\" target=\"_blank\">https:\/\/www.gao.gov\/products\/gao-05-212<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Food+Safety%3A+Experiences+of+Seven+Countries+in+Consolidating+Their+Food+Safety+Systems&rft.atitle=&rft.aulast=U.S.+Government+Accountability+Office&rft.au=U.S.+Government+Accountability+Office&rft.date=February+2005&rft_id=https%3A%2F%2Fwww.gao.gov%2Fproducts%2Fgao-05-212&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WhitworthReport22-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WhitworthReport22_10-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Whitworth, J. (22 February 2022). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.foodsafetynews.com\/2022\/02\/report-finds-food-testing-policies-different-between-countries\/\" target=\"_blank\">\"Report finds food testing policies different between countries\"<\/a>. <i>Food Safety News<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.foodsafetynews.com\/2022\/02\/report-finds-food-testing-policies-different-between-countries\/\" target=\"_blank\">https:\/\/www.foodsafetynews.com\/2022\/02\/report-finds-food-testing-policies-different-between-countries\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Report+finds+food+testing+policies+different+between+countries&rft.atitle=Food+Safety+News&rft.aulast=Whitworth%2C+J.&rft.au=Whitworth%2C+J.&rft.date=22+February+2022&rft_id=https%3A%2F%2Fwww.foodsafetynews.com%2F2022%2F02%2Freport-finds-food-testing-policies-different-between-countries%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SBCFood22-11\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-SBCFood22_11-0\">11.0<\/a><\/sup> <sup><a href=\"#cite_ref-SBCFood22_11-1\">11.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20230203164750\/https:\/\/www.scarborough.gov.uk\/home\/business-licensing-and-grants\/food-hygeine\/food-safety-regulations\" target=\"_blank\">\"Food safety regulations\"<\/a>. Scarborough Borough Council. 10 November 2022. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.scarborough.gov.uk\/home\/business-licensing-and-grants\/food-hygeine\/food-safety-regulations\" target=\"_blank\">the original<\/a> on 03 February 2023<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20230203164750\/https:\/\/www.scarborough.gov.uk\/home\/business-licensing-and-grants\/food-hygeine\/food-safety-regulations\" target=\"_blank\">https:\/\/web.archive.org\/web\/20230203164750\/https:\/\/www.scarborough.gov.uk\/home\/business-licensing-and-grants\/food-hygeine\/food-safety-regulations<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Food+safety+regulations&rft.atitle=&rft.date=10+November+2022&rft.pub=Scarborough+Borough+Council&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20230203164750%2Fhttps%3A%2F%2Fwww.scarborough.gov.uk%2Fhome%2Fbusiness-licensing-and-grants%2Ffood-hygeine%2Ffood-safety-regulations&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FSAKey22-12\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-FSAKey22_12-0\">12.0<\/a><\/sup> <sup><a href=\"#cite_ref-FSAKey22_12-1\">12.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.food.gov.uk\/about-us\/key-regulations\" target=\"_blank\">\"Key regulations\"<\/a>. Food Standards Agency. 30 August 2022<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.food.gov.uk\/about-us\/key-regulations\" target=\"_blank\">https:\/\/www.food.gov.uk\/about-us\/key-regulations<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Key+regulations&rft.atitle=&rft.date=30+August+2022&rft.pub=Food+Standards+Agency&rft_id=https%3A%2F%2Fwww.food.gov.uk%2Fabout-us%2Fkey-regulations&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FSA99Sec1-13\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FSA99Sec1_13-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.legislation.gov.uk\/ukpga\/1999\/28\/section\/1\" target=\"_blank\">\"1999 c. 28, The Food Standards Agency, Section 1\"<\/a>. <i>legislation.gov.uk<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.legislation.gov.uk\/ukpga\/1999\/28\/section\/1\" target=\"_blank\">https:\/\/www.legislation.gov.uk\/ukpga\/1999\/28\/section\/1<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=1999+c.+28%2C+The+Food+Standards+Agency%2C+Section+1&rft.atitle=legislation.gov.uk&rft_id=https%3A%2F%2Fwww.legislation.gov.uk%2Fukpga%2F1999%2F28%2Fsection%2F1&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FSAAbout-14\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FSAAbout_14-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gov.uk\/government\/organisations\/food-standards-agency\" target=\"_blank\">\"Food Standards Agency\"<\/a>. <i>Gov.uk<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.gov.uk\/government\/organisations\/food-standards-agency\" target=\"_blank\">https:\/\/www.gov.uk\/government\/organisations\/food-standards-agency<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Food+Standards+Agency&rft.atitle=Gov.uk&rft_id=https%3A%2F%2Fwww.gov.uk%2Fgovernment%2Forganisations%2Ffood-standards-agency&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FSAGuidReg-15\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FSAGuidReg_15-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gov.uk\/search\/guidance-and-regulation?organisations%5B%5D=food-standards-agency&parent=food-standards-agency\" target=\"_blank\">\"Guidance and regulation: Food Standards Agency (FSA)\"<\/a>. <i>Gov.uk<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.gov.uk\/search\/guidance-and-regulation?organisations%5B%5D=food-standards-agency&parent=food-standards-agency\" target=\"_blank\">https:\/\/www.gov.uk\/search\/guidance-and-regulation?organisations%5B%5D=food-standards-agency&parent=food-standards-agency<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Guidance+and+regulation%3A+Food+Standards+Agency+%28FSA%29&rft.atitle=Gov.uk&rft_id=https%3A%2F%2Fwww.gov.uk%2Fsearch%2Fguidance-and-regulation%3Forganisations%255B%255D%3Dfood-standards-agency%26parent%3Dfood-standards-agency&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PRSImplement-16\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-PRSImplement_16-0\">16.0<\/a><\/sup> <sup><a href=\"#cite_ref-PRSImplement_16-1\">16.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/prsindia.org\/policy\/report-summaries\/implementation-food-safety-and-standards-act-2006\" target=\"_blank\">\"Implementation of Food Safety and Standards Act, 2006\"<\/a>. <i>PRS Legislative Research<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/prsindia.org\/policy\/report-summaries\/implementation-food-safety-and-standards-act-2006\" target=\"_blank\">https:\/\/prsindia.org\/policy\/report-summaries\/implementation-food-safety-and-standards-act-2006<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Implementation+of+Food+Safety+and+Standards+Act%2C+2006&rft.atitle=PRS+Legislative+Research&rft_id=https%3A%2F%2Fprsindia.org%2Fpolicy%2Freport-summaries%2Fimplementation-food-safety-and-standards-act-2006&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FSSAIFood-17\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-FSSAIFood_17-0\">17.0<\/a><\/sup> <sup><a href=\"#cite_ref-FSSAIFood_17-1\">17.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/fssai.gov.in\/cms\/food-safety-and-standards-act-2006.php\" target=\"_blank\">\"Food Safety and Standards Act, 2006\"<\/a>. Food Safety and Standards Authority of India<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/fssai.gov.in\/cms\/food-safety-and-standards-act-2006.php\" target=\"_blank\">https:\/\/fssai.gov.in\/cms\/food-safety-and-standards-act-2006.php<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Food+Safety+and+Standards+Act%2C+2006&rft.atitle=&rft.pub=Food+Safety+and+Standards+Authority+of+India&rft_id=https%3A%2F%2Ffssai.gov.in%2Fcms%2Ffood-safety-and-standards-act-2006.php&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-UNEPFood15-18\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-UNEPFood15_18-0\">18.0<\/a><\/sup> <sup><a href=\"#cite_ref-UNEPFood15_18-1\">18.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Food and Agriculture Organization of the United Nations (24 April 2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/leap.unep.org\/countries\/cn\/national-legislation\/food-safety-law-2015\" target=\"_blank\">\"Food Safety Law (2015)\"<\/a>. <i>Law and Environment Assistance Platform<\/i>. United Nations Environmental Programme<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/leap.unep.org\/countries\/cn\/national-legislation\/food-safety-law-2015\" target=\"_blank\">https:\/\/leap.unep.org\/countries\/cn\/national-legislation\/food-safety-law-2015<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Food+Safety+Law+%282015%29&rft.atitle=Law+and+Environment+Assistance+Platform&rft.aulast=Food+and+Agriculture+Organization+of+the+United+Nations&rft.au=Food+and+Agriculture+Organization+of+the+United+Nations&rft.date=24+April+2015&rft.pub=United+Nations+Environmental+Programme&rft_id=https%3A%2F%2Fleap.unep.org%2Fcountries%2Fcn%2Fnational-legislation%2Ffood-safety-law-2015&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-USDAChina15-19\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-USDAChina15_19-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Foreign Agriculture Service Staff (18 May 2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/apps.fas.usda.gov\/newgainapi\/api\/report\/downloadreportbyfilename?filename=Amended%20Food%20Safety%20Law%20of%20China_Beijing_China%20-%20Peoples%20Republic%20of_5-18-2015.pdf\" target=\"_blank\">\"China's Food Safety Law (2015)\"<\/a> (PDF). <i>GAIN Repo<\/i>. U.S. Department of Agriculture<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/apps.fas.usda.gov\/newgainapi\/api\/report\/downloadreportbyfilename?filename=Amended%20Food%20Safety%20Law%20of%20China_Beijing_China%20-%20Peoples%20Republic%20of_5-18-2015.pdf\" target=\"_blank\">https:\/\/apps.fas.usda.gov\/newgainapi\/api\/report\/downloadreportbyfilename?filename=Amended%20Food%20Safety%20Law%20of%20China_Beijing_China%20-%20Peoples%20Republic%20of_5-18-2015.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=China%27s+Food+Safety+Law+%282015%29&rft.atitle=GAIN+Repo&rft.aulast=Foreign+Agriculture+Service+Staff&rft.au=Foreign+Agriculture+Service+Staff&rft.date=18+May+2015&rft.pub=U.S.+Department+of+Agriculture&rft_id=https%3A%2F%2Fapps.fas.usda.gov%2Fnewgainapi%2Fapi%2Freport%2Fdownloadreportbyfilename%3Ffilename%3DAmended%2520Food%2520Safety%2520Law%2520of%2520China_Beijing_China%2520-%2520Peoples%2520Republic%2520of_5-18-2015.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JLTFood47-20\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-JLTFood47_20-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.japaneselawtranslation.go.jp\/en\/laws\/view\/3687\/en\" target=\"_blank\">\"Food Sanitation Act (Act No. 233 of 1947)\"<\/a>. <i>Japanese Law Translation<\/i>. 24 December 1947<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.japaneselawtranslation.go.jp\/en\/laws\/view\/3687\/en\" target=\"_blank\">https:\/\/www.japaneselawtranslation.go.jp\/en\/laws\/view\/3687\/en<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Food+Sanitation+Act+%28Act+No.+233+of+1947%29&rft.atitle=Japanese+Law+Translation&rft.date=24+December+1947&rft_id=https%3A%2F%2Fwww.japaneselawtranslation.go.jp%2Fen%2Flaws%2Fview%2F3687%2Fen&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FSCFoodSafe03-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FSCFoodSafe03_21-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fsc.go.jp\/english\/basic_act\/fs_basic_act.pdf\" target=\"_blank\">\"Food Safety Basic Act\"<\/a> (PDF). Food Safety Commission of Japan. 23 May 2003<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fsc.go.jp\/english\/basic_act\/fs_basic_act.pdf\" target=\"_blank\">https:\/\/www.fsc.go.jp\/english\/basic_act\/fs_basic_act.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Food+Safety+Basic+Act&rft.atitle=&rft.date=23+May+2003&rft.pub=Food+Safety+Commission+of+Japan&rft_id=https%3A%2F%2Fwww.fsc.go.jp%2Fenglish%2Fbasic_act%2Ffs_basic_act.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BMFoodJapan18-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BMFoodJapan18_22-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Baker McKenzie (2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/resourcehub.bakermckenzie.com\/en\/resources\/asia-pacific-food-law-guide\/asia-pacific\/japan\/topics\/food-product-and-safety-regulation\" target=\"_blank\">\"Japan: Food product and safety regulation\"<\/a>. <i>Asia Pacific Food Law Guide<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/resourcehub.bakermckenzie.com\/en\/resources\/asia-pacific-food-law-guide\/asia-pacific\/japan\/topics\/food-product-and-safety-regulation\" target=\"_blank\">https:\/\/resourcehub.bakermckenzie.com\/en\/resources\/asia-pacific-food-law-guide\/asia-pacific\/japan\/topics\/food-product-and-safety-regulation<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Japan%3A+Food+product+and+safety+regulation&rft.atitle=Asia+Pacific+Food+Law+Guide&rft.aulast=Baker+McKenzie&rft.au=Baker+McKenzie&rft.date=2018&rft_id=https%3A%2F%2Fresourcehub.bakermckenzie.com%2Fen%2Fresources%2Fasia-pacific-food-law-guide%2Fasia-pacific%2Fjapan%2Ftopics%2Ffood-product-and-safety-regulation&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WeinrothHist18-23\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-WeinrothHist18_23-0\">23.0<\/a><\/sup> <sup><a href=\"#cite_ref-WeinrothHist18_23-1\">23.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Weinroth, Margaret D; Belk, Aeriel D; Belk, Keith E (9 November 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/academic.oup.com\/af\/article\/8\/4\/9\/5087923\" target=\"_blank\">\"History, development, and current status of food safety systems worldwide\"<\/a> (in en). <i>Animal Frontiers<\/i> <b>8<\/b> (4): 9\u201315. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1093%2Faf%2Fvfy016\" target=\"_blank\">10.1093\/af\/vfy016<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" data-key=\"a5dec3e4d005e654c29ad167ab53f53a\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/issn\/2160-6056\" target=\"_blank\">2160-6056<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6951898\/\" target=\"_blank\">PMC6951898<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32002225\" target=\"_blank\">32002225<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/academic.oup.com\/af\/article\/8\/4\/9\/5087923\" target=\"_blank\">https:\/\/academic.oup.com\/af\/article\/8\/4\/9\/5087923<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=History%2C+development%2C+and+current+status+of+food+safety+systems+worldwide&rft.jtitle=Animal+Frontiers&rft.aulast=Weinroth&rft.aufirst=Margaret+D&rft.au=Weinroth%2C%26%2332%3BMargaret+D&rft.au=Belk%2C%26%2332%3BAeriel+D&rft.au=Belk%2C%26%2332%3BKeith+E&rft.date=9+November+2018&rft.volume=8&rft.issue=4&rft.pages=9%E2%80%9315&rft_id=info:doi\/10.1093%2Faf%2Fvfy016&rft.issn=2160-6056&rft_id=info:pmc\/PMC6951898&rft_id=info:pmid\/32002225&rft_id=https%3A%2F%2Facademic.oup.com%2Faf%2Farticle%2F8%2F4%2F9%2F5087923&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FDAFood22-24\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-FDAFood22_24-0\">24.0<\/a><\/sup> <sup><a href=\"#cite_ref-FDAFood22_24-1\">24.1<\/a><\/sup> <sup><a href=\"#cite_ref-FDAFood22_24-2\">24.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/animal-veterinary\/animal-food-feeds\/food-safety-modernization-act-and-animal-food\" target=\"_blank\">\"Food Safety Modernization Act and Animal Food\"<\/a>. 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Commission+Regulation+%28EC%29+No+2073%2F2005+of+15+November+2005+on+microbiological+criteria+for+foodstuffs&rft.atitle=EUR-Lex&rft.date=3+August+2020&rft_id=https%3A%2F%2Feur-lex.europa.eu%2Flegal-content%2FEN%2FALL%2F%3Furi%3DCELEX%253A32005R2073&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-EFSAFoodClass-33\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EFSAFoodClass_33-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.efsa.europa.eu\/en\/data\/data-standardisation\" target=\"_blank\">\"Food classification standardisation \u2013 The FoodEx2 system\"<\/a>. 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Food+classification+standardisation+%E2%80%93+The+FoodEx2+system&rft.atitle=&rft.pub=European+Food+Safety+Authority&rft_id=https%3A%2F%2Fwww.efsa.europa.eu%2Fen%2Fdata%2Fdata-standardisation&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ManitobaSafe-34\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ManitobaSafe_34-0\">34.0<\/a><\/sup> <sup><a href=\"#cite_ref-ManitobaSafe_34-1\">34.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gov.mb.ca\/agriculture\/food-safety\/at-the-food-processor\/safe-food-for-canadians-act.html\" target=\"_blank\">\"Safe Food for Canadians Act\"<\/a>. 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Safe+Food+for+Canadians+Act&rft.atitle=&rft.pub=Manitoba+Government&rft_id=https%3A%2F%2Fwww.gov.mb.ca%2Fagriculture%2Ffood-safety%2Fat-the-food-processor%2Fsafe-food-for-canadians-act.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JLWSafeFood19-35\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-JLWSafeFood19_35-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/acts\/s-1.1\/index.html\" target=\"_blank\">\"Safe Food for Canadians Act (S.C. 2012, c. 24)\"<\/a>. <i>Justice Laws Website<\/i>. 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Government of Canada. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780660269856<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/inspection.canada.ca\/food-safety-for-industry\/toolkit-for-food-businesses\/sfcr-handbook-for-food-businesses\/eng\/1481560206153\/1481560532540?chap=0\" target=\"_blank\">https:\/\/inspection.canada.ca\/food-safety-for-industry\/toolkit-for-food-businesses\/sfcr-handbook-for-food-businesses\/eng\/1481560206153\/1481560532540?chap=0<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Understanding+the+Safe+Food+for+Canadians+Regulations%3A+A+handbook+for+food+businesses&rft.aulast=Canadian+Food+Inspection+Agency&rft.au=Canadian+Food+Inspection+Agency&rft.date=2018&rft.pub=Government+of+Canada&rft.isbn=9780660269856&rft_id=https%3A%2F%2Finspection.canada.ca%2Ffood-safety-for-industry%2Ftoolkit-for-food-businesses%2Fsfcr-handbook-for-food-businesses%2Feng%2F1481560206153%2F1481560532540%3Fchap%3D0&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ECFR21Part175-37\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ECFR21Part175_37-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-175?toc=1\" target=\"_blank\">\"Title 21, Chapter I, Subchapter B, Part 175\"<\/a>. <i>Code of Federal Regulations<\/i>. 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Australian+Packaging+Covenant&rft.atitle=&rft.date=2023&rft.pub=Department+of+Climate+Change%2C+Energy%2C+and+Environment+and+Water&rft_id=https%3A%2F%2Fwww.dcceew.gov.au%2Fenvironment%2Fprotection%2Fwaste%2Fplastics-and-packaging%2Fpackaging-covenant&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JLWSurface22-44\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-JLWSurface22_44-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2016-193\/page-1.html\" target=\"_blank\">\"Surface Coating Materials Regulations\"<\/a>. <i>Justice Laws Website<\/i>. 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Surface+Coating+Materials+Regulations&rft.atitle=Justice+Laws+Website&rft.date=19+December+2022&rft.pub=Government+of+Canada&rft_id=https%3A%2F%2Flaws-lois.justice.gc.ca%2Feng%2Fregulations%2FSOR-2016-193%2Fpage-1.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MPWGSRegul11-45\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-MPWGSRegul11_45-0\">45.0<\/a><\/sup> <sup><a href=\"#cite_ref-MPWGSRegul11_45-1\">45.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Office of the Auditor General of Canada (2011). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/publications.gc.ca\/collections\/collection_2012\/bvg-oag\/FA1-2011-2-4-eng.pdf\" target=\"_blank\">\"Chapter 4: Regulating Pharmaceutical Drugs - Health Canada\"<\/a> (PDF). <i>Report of the Auditor General of Canada to the House of Commons<\/i>. Minister of Public Works and Government Services. pp. 1\u201338. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9781100194028<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/publications.gc.ca\/collections\/collection_2012\/bvg-oag\/FA1-2011-2-4-eng.pdf\" target=\"_blank\">https:\/\/publications.gc.ca\/collections\/collection_2012\/bvg-oag\/FA1-2011-2-4-eng.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+4%3A+Regulating+Pharmaceutical+Drugs+-+Health+Canada&rft.atitle=Report+of+the+Auditor+General+of+Canada+to+the+House+of+Commons&rft.aulast=Office+of+the+Auditor+General+of+Canada&rft.au=Office+of+the+Auditor+General+of+Canada&rft.date=2011&rft.pages=pp.%26nbsp%3B1%E2%80%9338&rft.pub=Minister+of+Public+Works+and+Government+Services&rft.isbn=9781100194028&rft_id=https%3A%2F%2Fpublications.gc.ca%2Fcollections%2Fcollection_2012%2Fbvg-oag%2FFA1-2011-2-4-eng.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BasakIndian23-46\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BasakIndian23_46-0\">46.0<\/a><\/sup> <sup><a href=\"#cite_ref-BasakIndian23_46-1\">46.1<\/a><\/sup> <sup><a href=\"#cite_ref-BasakIndian23_46-2\">46.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Basak, S. (13 February 2023). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.outlookindia.com\/national\/indian-pharma-irregularities-hint-at-lack-of-drug-regulation-policies-and-better-oversight-news-261625\" target=\"_blank\">\"Indian Pharma Irregularities Point To Lack Of Drug Regulation Policies And Better Oversight\"<\/a>. <i>Outlook<\/i>. Outlook Publishing India Pvt. Ltd<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.outlookindia.com\/national\/indian-pharma-irregularities-hint-at-lack-of-drug-regulation-policies-and-better-oversight-news-261625\" target=\"_blank\">https:\/\/www.outlookindia.com\/national\/indian-pharma-irregularities-hint-at-lack-of-drug-regulation-policies-and-better-oversight-news-261625<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Indian+Pharma+Irregularities+Point+To+Lack+Of+Drug+Regulation+Policies+And+Better+Oversight&rft.atitle=Outlook&rft.aulast=Basak%2C+S.&rft.au=Basak%2C+S.&rft.date=13+February+2023&rft.pub=Outlook+Publishing+India+Pvt.+Ltd&rft_id=https%3A%2F%2Fwww.outlookindia.com%2Fnational%2Findian-pharma-irregularities-hint-at-lack-of-drug-regulation-policies-and-better-oversight-news-261625&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BhattIncon23-47\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BhattIncon23_47-0\">47.0<\/a><\/sup> <sup><a href=\"#cite_ref-BhattIncon23_47-1\">47.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Bhatt, Neha (13 January 2023). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bmj.com\/lookup\/doi\/10.1136\/bmj.p23\" target=\"_blank\">\"Inconsistent drug regulation spells danger for India\u2019s global pharma ambitions\"<\/a> (in en). <i>BMJ<\/i>: p23. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1136%2Fbmj.p23\" target=\"_blank\">10.1136\/bmj.p23<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" data-key=\"a5dec3e4d005e654c29ad167ab53f53a\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/issn\/1756-1833\" target=\"_blank\">1756-1833<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.bmj.com\/lookup\/doi\/10.1136\/bmj.p23\" target=\"_blank\">https:\/\/www.bmj.com\/lookup\/doi\/10.1136\/bmj.p23<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Inconsistent+drug+regulation+spells+danger+for+India%E2%80%99s+global+pharma+ambitions&rft.jtitle=BMJ&rft.aulast=Bhatt&rft.aufirst=Neha&rft.au=Bhatt%2C%26%2332%3BNeha&rft.date=13+January+2023&rft.pages=p23&rft_id=info:doi\/10.1136%2Fbmj.p23&rft.issn=1756-1833&rft_id=https%3A%2F%2Fwww.bmj.com%2Flookup%2Fdoi%2F10.1136%2Fbmj.p23&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-48\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-48\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Kukade, T.; Punnen, D.; Antani, M. (24 June 2022). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.natlawreview.com\/article\/mid-year-regulatory-update-2022-pharmaceuticals-india\" target=\"_blank\">\"Mid-Year Regulatory Update 2022: Pharmaceuticals in India\"<\/a>. <i>The National Law Review<\/i> <b>XII<\/b> (175)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.natlawreview.com\/article\/mid-year-regulatory-update-2022-pharmaceuticals-india\" target=\"_blank\">https:\/\/www.natlawreview.com\/article\/mid-year-regulatory-update-2022-pharmaceuticals-india<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Mid-Year+Regulatory+Update+2022%3A+Pharmaceuticals+in+India&rft.jtitle=The+National+Law+Review&rft.aulast=Kukade%2C+T.%3B+Punnen%2C+D.%3B+Antani%2C+M.&rft.au=Kukade%2C+T.%3B+Punnen%2C+D.%3B+Antani%2C+M.&rft.date=24+June+2022&rft.volume=XII&rft.issue=175&rft_id=https%3A%2F%2Fwww.natlawreview.com%2Farticle%2Fmid-year-regulatory-update-2022-pharmaceuticals-india&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HCDrug22-49\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HCDrug22_49-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Health Canada (20 June 2022). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/drug-products\/legislation-guidelines.html\" target=\"_blank\">\"Drug products legislation and guidelines\"<\/a>. Government of Canada<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/drug-products\/legislation-guidelines.html\" target=\"_blank\">https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/drug-products\/legislation-guidelines.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Drug+products+legislation+and+guidelines&rft.atitle=&rft.aulast=Health+Canada&rft.au=Health+Canada&rft.date=20+June+2022&rft.pub=Government+of+Canada&rft_id=https%3A%2F%2Fwww.canada.ca%2Fen%2Fhealth-canada%2Fservices%2Fdrugs-health-products%2Fdrug-products%2Flegislation-guidelines.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JLWFoodDrug23-50\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-JLWFoodDrug23_50-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/lois.justice.gc.ca\/eng\/regulations\/C.R.C.,_c._870\/index.html\" target=\"_blank\">\"Food and Drug Regulations (C.R.C., c. 870)\"<\/a>. <i>Justice Laws Website<\/i>. Government of Canada. 15 February 2023<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/lois.justice.gc.ca\/eng\/regulations\/C.R.C.,_c._870\/index.html\" target=\"_blank\">https:\/\/lois.justice.gc.ca\/eng\/regulations\/C.R.C.,_c._870\/index.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Food+and+Drug+Regulations+%28C.R.C.%2C+c.+870%29&rft.atitle=Justice+Laws+Website&rft.date=15+February+2023&rft.pub=Government+of+Canada&rft_id=https%3A%2F%2Flois.justice.gc.ca%2Feng%2Fregulations%2FC.R.C.%2C_c._870%2Findex.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PBMKorea18-51\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-PBMKorea18_51-0\">51.0<\/a><\/sup> <sup><a href=\"#cite_ref-PBMKorea18_51-1\">51.1<\/a><\/sup> <sup><a href=\"#cite_ref-PBMKorea18_51-2\">51.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pacificbridgemedical.com\/regulation\/korea-medical-device-pharmaceutical-regulations\/\" target=\"_blank\">\"Korea Medical Device and Pharmaceutical Regulations\"<\/a>. Pacific Bridge Medical. 12 August 2018<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.pacificbridgemedical.com\/regulation\/korea-medical-device-pharmaceutical-regulations\/\" target=\"_blank\">https:\/\/www.pacificbridgemedical.com\/regulation\/korea-medical-device-pharmaceutical-regulations\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Korea+Medical+Device+and+Pharmaceutical+Regulations&rft.atitle=&rft.date=12+August+2018&rft.pub=Pacific+Bridge+Medical&rft_id=https%3A%2F%2Fwww.pacificbridgemedical.com%2Fregulation%2Fkorea-medical-device-pharmaceutical-regulations%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KLRIPharm17-52\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KLRIPharm17_52-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elaw.klri.re.kr\/eng_service\/lawView.do?hseq=40196&lang=ENG\" target=\"_blank\">\"Pharmaceutical Affairs Act\"<\/a>. 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Medical+Devices+Act&rft.atitle=&rft.date=12+July+2018&rft.pub=Korea+Legislation+Research+Institute&rft_id=https%3A%2F%2Felaw.klri.re.kr%2Feng_service%2FlawView.do%3Fhseq%3D48691%26lang%3DENG&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JPMAPharm20-54\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-JPMAPharm20_54-0\">54.0<\/a><\/sup> <sup><a href=\"#cite_ref-JPMAPharm20_54-1\">54.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Regulatory Information Task Force (2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jpma.or.jp\/english\/about\/parj\/eki4g6000000784o-att\/2020e_ch02.pdf\" target=\"_blank\">\"Chapter 2: Pharmaceutical Laws and Regulations\"<\/a> (PDF). <i>Pharmaceutical Administration and Regulations in Japan<\/i>. Japan Pharmaceutical Manufacturers Association. pp. 15\u201356<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.jpma.or.jp\/english\/about\/parj\/eki4g6000000784o-att\/2020e_ch02.pdf\" target=\"_blank\">https:\/\/www.jpma.or.jp\/english\/about\/parj\/eki4g6000000784o-att\/2020e_ch02.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+2%3A+Pharmaceutical+Laws+and+Regulations&rft.atitle=Pharmaceutical+Administration+and+Regulations+in+Japan&rft.aulast=Regulatory+Information+Task+Force&rft.au=Regulatory+Information+Task+Force&rft.date=2020&rft.pages=pp.%26nbsp%3B15%E2%80%9356&rft.pub=Japan+Pharmaceutical+Manufacturers+Association&rft_id=https%3A%2F%2Fwww.jpma.or.jp%2Fenglish%2Fabout%2Fparj%2Feki4g6000000784o-att%2F2020e_ch02.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BSIJapan16-55\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BSIJapan16_55-0\">55.0<\/a><\/sup> <sup><a href=\"#cite_ref-BSIJapan16_55-1\">55.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bsigroup.com\/meddev\/LocalFiles\/en-US\/Brochures\/bsi-md-japan-brochure.pdf\" target=\"_blank\">\"Japan Pharmaceutical and Medical Device Act\"<\/a> (PDF). BSI Group America, Inc. November 2016<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.bsigroup.com\/meddev\/LocalFiles\/en-US\/Brochures\/bsi-md-japan-brochure.pdf\" target=\"_blank\">https:\/\/www.bsigroup.com\/meddev\/LocalFiles\/en-US\/Brochures\/bsi-md-japan-brochure.pdf<\/a><\/span><span class=\"reference-accessdate\">. 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Know good manufacturing practices (GMP)\"<\/a>. <i>Control Engineering<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.controleng.com\/articles\/regulated-or-not-know-good-manufacturing-practices-gmp\/\" target=\"_blank\">https:\/\/www.controleng.com\/articles\/regulated-or-not-know-good-manufacturing-practices-gmp\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Regulated+or+not%3F+Know+good+manufacturing+practices+%28GMP%29&rft.atitle=Control+Engineering&rft.aulast=%27%27Control+Engineering%27%27+Staff&rft.au=%27%27Control+Engineering%27%27+Staff&rft.date=14+July+2007&rft_id=https%3A%2F%2Fwww.controleng.com%2Farticles%2Fregulated-or-not-know-good-manufacturing-practices-gmp%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FDAGMPCosm22-59\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FDAGMPCosm22_59-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-guidance-documents\/good-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics\" target=\"_blank\">\"Good Manufacturing Practice (GMP) Guidelines\/Inspection Checklist for Cosmetics\"<\/a>. U.S. Food and Drug Administration. 25 February 2022<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-guidance-documents\/good-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics\" target=\"_blank\">https:\/\/www.fda.gov\/cosmetics\/cosmetics-guidance-documents\/good-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics<\/a><\/span><span class=\"reference-accessdate\">. 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Difference+Between+GMP+and+cGMP&rft.atitle=Pharma+Specialists&rft.date=13+October+2021&rft_id=https%3A%2F%2Fwww.pharmaspecialists.com%2F2021%2F10%2Fdifference-between-gmp-and-cgmp.html%23gsc.tab%3D0&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MoravekTheDiff-61\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MoravekTheDiff_61-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.moravek.com\/the-differences-between-gmp-and-cgmp\/\" target=\"_blank\">\"The Differences Between GMP and cGMP\"<\/a>. <i>Moravek Blog<\/i>. Moravek, Inc. January 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.moravek.com\/the-differences-between-gmp-and-cgmp\/\" target=\"_blank\">https:\/\/www.moravek.com\/the-differences-between-gmp-and-cgmp\/<\/a><\/span><span class=\"reference-accessdate\">. 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=REACH+%28Registration%2C+Evaluation%2C+Authorization%2C+and+Restriction+of+Chemicals%29&rft.atitle=&rft.date=2021&rft.pub=Electronic+Components+Industry+Association&rft_id=https%3A%2F%2Fwww.ecianow.org%2Freach&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HavensBrazil21-68\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HavensBrazil21_68-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Havens, R. (2 September 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ul.com\/news\/brazil-revises-list-prohibited-substances-cosmetics\" target=\"_blank\">\"Brazil Revises List of Prohibited Substances in Cosmetics\"<\/a>. <i>UL Solutions<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.ul.com\/news\/brazil-revises-list-prohibited-substances-cosmetics\" target=\"_blank\">https:\/\/www.ul.com\/news\/brazil-revises-list-prohibited-substances-cosmetics<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Brazil+Revises+List+of+Prohibited+Substances+in+Cosmetics&rft.atitle=UL+Solutions&rft.aulast=Havens%2C+R.&rft.au=Havens%2C+R.&rft.date=2+September+2021&rft_id=https%3A%2F%2Fwww.ul.com%2Fnews%2Fbrazil-revises-list-prohibited-substances-cosmetics&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ECRestrict-69\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ECRestrict_69-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/environment.ec.europa.eu\/topics\/waste-and-recycling\/rohs-directive_en\" target=\"_blank\">\"Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS)\"<\/a>. European Commission. 2023<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/environment.ec.europa.eu\/topics\/waste-and-recycling\/rohs-directive_en\" target=\"_blank\">https:\/\/environment.ec.europa.eu\/topics\/waste-and-recycling\/rohs-directive_en<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Restriction+of+Hazardous+Substances+in+Electrical+and+Electronic+Equipment+%28RoHS%29&rft.atitle=&rft.date=2023&rft.pub=European+Commission&rft_id=https%3A%2F%2Fenvironment.ec.europa.eu%2Ftopics%2Fwaste-and-recycling%2Frohs-directive_en&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DITRDCARoad23-70\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DITRDCARoad23_70-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Department of Infrastructure, Transport, Regional Development, Communications and the Arts (2023). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.infrastructure.gov.au\/infrastructure-transport-vehicles\/vehicles\/road-vehicle-standards-laws\" target=\"_blank\">\"Road Vehicle Standards laws\"<\/a>. Australian Government<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.infrastructure.gov.au\/infrastructure-transport-vehicles\/vehicles\/road-vehicle-standards-laws\" target=\"_blank\">https:\/\/www.infrastructure.gov.au\/infrastructure-transport-vehicles\/vehicles\/road-vehicle-standards-laws<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Road+Vehicle+Standards+laws&rft.atitle=&rft.aulast=Department+of+Infrastructure%2C+Transport%2C+Regional+Development%2C+Communications+and+the+Arts&rft.au=Department+of+Infrastructure%2C+Transport%2C+Regional+Development%2C+Communications+and+the+Arts&rft.date=2023&rft.pub=Australian+Government&rft_id=https%3A%2F%2Fwww.infrastructure.gov.au%2Finfrastructure-transport-vehicles%2Fvehicles%2Froad-vehicle-standards-laws&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DITRDCAusDes23-71\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DITRDCAusDes23_71-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Department of Infrastructure, Transport, Regional Development, Communications and the Arts (2023). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.infrastructure.gov.au\/infrastructure-transport-vehicles\/vehicles\/vehicle-design-regulation\/australian-design-rules\" target=\"_blank\">\"Australian Design Rules\"<\/a>. Australian Government<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.infrastructure.gov.au\/infrastructure-transport-vehicles\/vehicles\/vehicle-design-regulation\/australian-design-rules\" target=\"_blank\">https:\/\/www.infrastructure.gov.au\/infrastructure-transport-vehicles\/vehicles\/vehicle-design-regulation\/australian-design-rules<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Australian+Design+Rules&rft.atitle=&rft.aulast=Department+of+Infrastructure%2C+Transport%2C+Regional+Development%2C+Communications+and+the+Arts&rft.au=Department+of+Infrastructure%2C+Transport%2C+Regional+Development%2C+Communications+and+the+Arts&rft.date=2023&rft.pub=Australian+Government&rft_id=https%3A%2F%2Fwww.infrastructure.gov.au%2Finfrastructure-transport-vehicles%2Fvehicles%2Fvehicle-design-regulation%2Faustralian-design-rules&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DITRDCTesting23-72\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DITRDCTesting23_72-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Department of Infrastructure, Transport, Regional Development, Communications and the Arts (2023). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.infrastructure.gov.au\/infrastructure-transport-vehicles\/vehicles\/rvs\/testing-facilities\" target=\"_blank\">\"Testing facilities\"<\/a>. Australian Government<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.infrastructure.gov.au\/infrastructure-transport-vehicles\/vehicles\/rvs\/testing-facilities\" target=\"_blank\">https:\/\/www.infrastructure.gov.au\/infrastructure-transport-vehicles\/vehicles\/rvs\/testing-facilities<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Testing+facilities&rft.atitle=&rft.aulast=Department+of+Infrastructure%2C+Transport%2C+Regional+Development%2C+Communications+and+the+Arts&rft.au=Department+of+Infrastructure%2C+Transport%2C+Regional+Development%2C+Communications+and+the+Arts&rft.date=2023&rft.pub=Australian+Government&rft_id=https%3A%2F%2Fwww.infrastructure.gov.au%2Finfrastructure-transport-vehicles%2Fvehicles%2Frvs%2Ftesting-facilities&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<p><br \/>\n<\/p>\n<div align=\"center\">-----Go to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Choosing laboratory informatics software for your manufacturing lab\/Evaluation and selection\" class=\"wiki-link\" data-key=\"65f78607cbccba23967db83197332e4c\">the next chapter<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: 2. Standards and regulations affecting manufacturing labs\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for Manufacturing Quality Control<\/i>\n<\/p><p><b>Edition<\/b>: First Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: May 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230516215610\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.849 seconds\nReal time usage: 0.889 seconds\nPreprocessor visited node count: 49416\/1000000\nPost\u2010expand include size: 385723\/2097152 bytes\nTemplate argument size: 134291\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 121808\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 793.574 1 -total\n 93.37% 740.977 1 Template:Reflist\n 77.29% 613.341 72 Template:Citation\/core\n 62.43% 495.394 61 Template:Cite_web\n 16.14% 128.071 8 Template:Cite_book\n 15.24% 120.933 56 Template:Date\n 6.61% 52.441 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\n 5.98% 47.482 3 Template:Cite_journal\n 4.44% 35.208 102 Template:Citation\/make_link\n 3.81% 30.242 12 Template:Citation\/identifier\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14177-0!canonical and timestamp 20230516215609 and revision id 51999. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","829960d7b100216b435c1232f06318e6_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/b2\/Food-safety-modernization-act-fsma.png","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/a\/a4\/Assessing_prototype_reference_material_for_testing_emissions_of_VOCs_%285940985174%29.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/c\/c9\/Generic_Drug_Research_%285896%29_%288493711422%29.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/8\/80\/GMP_GOOD_MANUFACTURING_PRACTICE.png"],"829960d7b100216b435c1232f06318e6_timestamp":1684275143,"15a608383abc44912e4e0b246caa1a92_type":"article","15a608383abc44912e4e0b246caa1a92_title":"2.1 Globally recognized manufacturing standards","15a608383abc44912e4e0b246caa1a92_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards","15a608383abc44912e4e0b246caa1a92_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Standards and regulations affecting manufacturing labs\/Globally recognized manufacturing standardsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 2. Standards and regulations affecting manufacturing labs \n\n1.1 2.1 Globally recognized manufacturing standards \n\n1.1.1 2.1.1 Food and beverage \n1.1.2 2.1.2 Materials \n1.1.3 2.1.3 Pharmaceutical and medical devices \n1.1.4 2.1.4 Other industries and standards \n\n\n\n\n2 References \n\n\n\n2. Standards and regulations affecting manufacturing labs \nSocieties around the world have grown to expect and depend on high-quality products that prove safe to their health, fully functional, and as-advertised. However, all manufacturers have not been equal in striving for and meeting such goals over the years, requiring standardization and regulatory tools to better drive the development and production of safe, high-quality products. As we learned in the previous chapter, manufacturing-based laboratories are critically involved in that manufacturing goal, and as such, those laboratories are in part guided and driven by manufacturing standards and regulations. After all, accurate and timely laboratory results are critical to the processes of research and development (R&D), quality control (QC), and post-production analyses. Naturally, standards and regulations may differ slightly from country to country, which should not be surprising. However, international efforts towards standards harmonization are ongoing as a means to make international trade more productive and to expand quality processes beyond national borders.\nThat said, \"manufacturing\" is a broad realm, as noted at the beginning of Chapter 1. The standards and regulations impacting textile manufacturers, for example, may differ greatly from those applied to pharmaceutical or electric vehicle manufacturers. As such, it's difficult to broadly make statements about standardization and regulation of the manufacturing industries. However, this chapter will attempt to examine some of these aspects from the 30,000 foot view, while focusing on providing examples across multiple manufacturing industries. Here we'll briefly examine the standards, regulations, guidance, and other factors globally driven by not only the demand for safer products, but also that in many cases dictate what and how quality activities are conducted towards ensuring product safety around the world inside and outside the manufacturing-based laboratory.\n\r\n\n\n2.1 Globally recognized manufacturing standards \nManufacturing industries of all types depend on well-defined and -justified standards to better ensure the quality of their products. Implementing and maintaining conformance to internationally recognized and benchmarked safety and quality standards benefits the manufacturer in a number of ways[1][2][3][4]:\n\nIt increases customer confidence through the organization's audited certification to the standard, taking the place of customers' own auditing methods to ensure quality and authenticity, in turn reducing time and costs.\nIt drives organizations to better monitor their activities for non-conformities, identify root causes, and develop preventative controls, while clearly reporting such efforts to customers, further reducing the need for customer audits.\nIt better ensures a rigorous and comprehensive approach to product safety, quality, integrity, and legality, in many cases meeting or exceeding local, state, federal, and\/or international legislative requirements.\nIt drives organizations to better vet their suppliers and service providers for meeting required product safety management practices.\nIt enables organizations to better demonstrate auditable compliance with modern product safety management practices.\nIt allows organizations to limit product recalls, reduce customer complaints, and better protect their brand.\nAs such, manufacturers adopt standards from one or more organizations around the world, not only to benefit their operations but also meet or exceed regulatory requirements for their industry. What follows are some of the more critical standards and guidelines that apply to a wide variety of manufacturing industries.\n\n2.1.1 Food and beverage \nFood and beverage researchers and manufacturers adopt standards from one or more organizations around the world, not only to benefit their operations but also meet or exceed regulatory requirements for their industry. What follows are some of the more critical standards and guidelines that apply to the food, beverage, and feed industries.\n2.1.1.1 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)\nIn 1998, the British Retail Consortium (BRD) published the first edition of its Global Standard for Food Safety (GSFS), going on to become an internationally recognized standard of best practices in food manufacturing, storage, and distribution, and the first food safety standard to be recognized by the Global Food Safety Initiative (GFSI; discussed later). The standard covers stakeholder buy-in on continual improvement, food safety plan development, food quality management system development, manufacturing and storage site standardization, product and process control, personnel management, risk management, and trade product management.[3][4][5][6] The standard is implemented by an organization through gap assessment, documentation development, consultation and assessment, internal auditing, and resolving non-conformances to the standard.[4] \n2.1.1.2 Codex Alimentarius\nThe Codex Alimentarius is a collection of internationally recognized food and feed standards and guidelines developed as a joint venture between the United Nation's Food and Agricultural Organization (FAO) and the World Health Organization (WHO).[5] The Codex \"is intended to guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and in doing so to facilitate international trade.\"[7] Scope of the standards is broad, covering food hygiene; food additives and contaminants, including pesticides and drugs; packaging and labeling; sampling and analysis methods; and import and export inspection and certification.[7] It's not unusual for governments to approach the FAO seeking help with harmonizing national legal frameworks of food safety with the Codex Alimentarius.[8] Among the Codex, some of the more broadly useful standards include General Principles of Food Hygiene (CXC 1-1969)[9], General Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995), and General Methods of Analysis for Contaminants (CXS 228-2001).[10]\n2.1.1.3 Global Food Safety Initiative (GFSI)\nThe GFSI is a collection of private organizations that has developed a set of benchmarking requirements for improving food safety management programs, with a goal of making them balanced enough to be broadly applicable while remaining relevant to different countries and regions of the world.[5] Previously known as the GFSI Guidance Document[11], the GFSI Benchmarking Requirements act as a set of criteria and professional framework for food safety management programs to fulfill, formally allowing an organization to be recognized and certified by the GFSI. Certification to the GFSI Benchmarking Requirements \"demonstrates an organization\u2019s serious commitment to food safety to customers and potential customers across the world.\"[5] An organization seeks out a third-party certification program owner (CPO) and undergoes the auditing process, which is driven and supported by the GFSI Benchmarking Requirements.[12] GFSI is also responsible for ensuring CPOs and certification bodies meet the necessary requirements.\n2.1.1.4 Hazard analysis and critical control points (HACCP)\nThe hazard analysis and critical control points or HACCP system has been adopted and integrated in various ways over the years[13], but at its core, the system directs organizations to focus on key areas or \"critical control points\" (CCPs) of vulnerability and hazard within the production process and mitigate their impact on overall food safety.[5] Though the seeds of HACCP go back to the 1970s, it wasn't until the mid-1990s that it began finding its way into formal regulatory structures in the United States, first codified as 9 CFR Parts 304, 308, 310, 320, 327, 381, 416, and 417 in July 1996.[13][14] HACCP also found its way into other standards benchmarked by the GFSI.[13] The concept of HACCP has perhaps changed slightly over the years, but the main principles remain[5]:\n\nConduct a hazard analysis.\nIdentify CCPs.\nEstablish critical limits for those CCPs.\nEstablish monitoring procedures for those CCPs.\nEstablish corrective action for failed limits.\nEstablish verification procedures.\nEstablish record keeping and documentation procedures.\n2.1.1.5 International Featured Standards (IFS)\nThe IFS framework is made up of a group of eight food and non-food standards, covering various processes along the food supply chain. IFS Management, who is responsible for the standards, notes that \"IFS does not specify what these processes must look like but merely provides a risk-based assessment\"[15] or \"uniform evaluation system\"[5] for them. Organizations such as food manufacturers and logistics providers can certify to the standards. Some of the more relevant to food and beverage laboratories include IFS Food (for food manufacturers), IFS Global Markets Food (for food retailers), IFS PACsecure 2 (for packaging manufactures), and IFS Global Markets PACsecure (for packaging suppliers).[15]\n2.1.1.6 International Organization for Standardization (ISO) 22000\nThe ISO 22000 series of standards addresses how a food safety management system should be set up and operated, and how organizations can be certified to the standard by a third-party auditor.[16] ISO 22000 is based off the ISO 9000 family of quality management system standards and, like other standards, incorporates elements of HACCP.[13] The standard claims to be advantaged compared to other standards due to its comprehensive applicability across an entire organization, and across the entire food chain.[17] Major standards applicable to manufacturers with laboratories include:\n\nISO\/TS 22002-1:2009 Prerequisite programmes on food safety \u2014 Part 1: Food manufacturing[18]\nISO\/TS 22002-4:2013 Prerequisite programmes on food safety \u2014 Part 4: Food packaging manufacturing[19]\nISO\/TS 22002-6:2016 Prerequisite programmes on food safety \u2014 Part 6: Feed and animal food production[20]\n2.1.1.7 Safe Quality Food (SQF) Program\nThe SQF Program, headlined by the SQF Institute and recognized by the GFSI, is a food \"safety-plus-quality\" management certification mechanism that covers the food supply chain from farm to fork.[5] Those who wish to be certified to SQF must comply with SQF Code, which covers a variety of topics, from aquaculture and farming to food packaging and food and feed manufacturing.[21] Like other standards, the organization wanting to be accredited finds a certified third-party auditor to administer program certification.\n\n2.1.2 Materials \nAn internet search for \"materials engineering standards\" reveals dozens of university library research guides discussing what standards are, why they are important to materials science and engineering, and how to find them via the university's library system. Take for example UCLA's Materials Science and Engineering guide and its relatively succinct description of why standards are important to materials scientists[22]:\nStandards and specifications are described as documents that describe the rules and conditions for how materials and products should be manufactured, defined, measured, tested, and applied. They are used to establish baselines or a minimum level of performance and quality control to ensure that optimal conditions and procedures for the purpose of creating compatibility with products and services from different periods and a range of sources. Specifications have a more limited range of application than standards and generally establish requirements for materials, products, or services. Standards and specifications may be issued by voluntary technical or trade associations, professional societies, national standards bodies, government agencies, or by international organizations ... Standards and specifications are of greatest utility to engineers, scientists, and those working with new innovations.\nUCLA helpfully goes on to describe the types of standards one should expect to find in regards to materials science and engineering, including categorical (e.g., dimension, structure, grade, durability, safety), method-based (e.g., manufacturing, design, operational safety), testing-based (e.g., analyzing, measuring, verifying), term-based (e.g., abbreviations, symbology, preferred units), and design (e.g., execution method, safety conditions) standards.[22] As such, it would be practically impossible to address all materials-related standards in this guide. However, a small selection of examples is provided to give varying contexts of what materials engineers and manufacturers may need to consider.\n2.1.2.1 American Society of Civil Engineers (ASCE) materials standards\nThe ASCE is a professional organization with its own library of standards, including materials standards for engineering. Examples include ASCE\/T&DI\/ICPI 58-16 Structural Design of Interlocking Concrete Pavement for Municipal Streets and Roadways, ASCE\/SEI 19-16 Structural Applications of Steel Cables for Buildings, and ASCE\/SEI 48-05 Design of Steel Transmission Pole Structures. \n2.1.2.2 ASTM International Volume 15.04\nASTM International has numerous volumes of standards for materials, including Volume 15.04. This volume covers the chemical requirements for soaps and other detergents, the properties of polishes, various properties and test methods of leather, and the properties of floor coverings.[23]\n2.1.2.3 Canadian Standards Association (CSA) A3000 series\nThe CSA produces standards for a variety of materials, including cementitious materials through its A3000 series of standards. These construction materials standards address the basics of cementitious materials, their appropriate test methods, and the equipment best used for those methods.[24]\n2.1.2.4 International Organization for Standardization (ISO) 10993\nGenerally speaking, there are no ISO or government-sanctioned standards for the materials that can be used in medical devices, but rather there are standards that apply directly to medical devices, largely given that the overall manufacturing process has a tendency to modify the reactivity of the material used in the medical device.[25] That being said, there is an ISO standard for biocompatibility, \"the ability of a device material to perform with an appropriate host response in a specific situation\"[26]: the ISO 10993 series of standards.[25] These standards requires manufacturers of medical devices to collect \"qualitative and quantitative data on the materials in the context of biological safety\" to ensure the device's material is actually biocompatible.[25] ISO 10933 addresses chemical characterization, allowable limits of leachable substances, and in vitro cytotoxicity of medical device materials, among other things.[25]\n2.1.2.5 Metal Powder Industries Federation (MPIF) Standard 35 family\nThe MPIF \"issues standards to provide the design and materials engineer with the information necessary for specifying powder metallurgy materials which have been developed by the powder metallurgy and metal injection molding parts, powder, and equipment producers.\"[27] Among them is the Standard 35 family, which addresses powder metallurgy structural parts and self-lubricating bearings, as well as powder-forged steel and metal injection molded parts, including materials aspects such as \"minimum strength value, grade selection, chemistry, proof testing, typical property values, and processes.\"[27]\n\n2.1.3 Pharmaceutical and medical devices \nOf the various manufacturing domains, pharmaceutical and medical device manufacturing arguably requires some of the most rigorous standards to ensure the good health of end users. Speaking to consumer expectations of safe, high-quality pharmaceutical products, Atouf and Venema note[28]:\nThe consistency in both the safety and efficacy of the drug supply required to achieve this assurance is based mainly on our reliance on compendial standards for quality and performance of drug development, review, and ongoing manufacturing. These standards are recognized in the [Food, Drug and Cosmetic Act] and play a critical role in its adulteration and misbranding provisions ... The impact of established and accepted standards\u2014in the form of measurements and methods as well as reference materials\u2014being a norm for drug development often goes unnoticed and unmeasured, even by those intimately involved in the field. By the very fact of being the norm, they are taken for granted. Their impact is nonetheless fundamental to the current and future efficiency of drug development as well as to the pursuit of providing safe, high-quality medicines at a reasonable price.\nSimilarly, harmonized medical device standards are valuable to manufacturers and end users, making it \"possible to apply essential requirements\" of development and manufacturing \"in a uniform way.\" Manufacturers can adopt harmonized standards in such a way that design and documentation costs are reduced, while at the same time giving end users more confidence in the safety and efficacy of manufactured devices.[29]\nLike materials standards, it's beyond the scope of this guide to try and list all pharmaceutical and medical device standards. What follows are a few examples of more critical standards in this industry.\n2.1.3.1 ASTM International Volume 14.01\nASTM International covers pharmaceutical and biopharmaceutical manufacturing in its Volume 14.01. In particular, it \"covers the application of process analytical technology (PAT) within the pharmaceutical and biopharmaceutical industry, highlighting PAT system management, implementation, and practices.\"[30]\n2.1.3.2 European Pharmacopoeia standards\nThe European Pharmacopoeia is a compendium of standards\u2014in the form of monographs and other documents\u2014that provides \"a legal and scientific basis for quality control during the development, production and marketing\" of pharmaceuticals and their ingredients. These standards address the compositions, testing, and handling of medicines and their ingredients to better ensure the safety of consumers and a more effective product.[31] The eleventh edition contains more than 2,400 monographs, 380 general texts, and 2,800 descriptions of reagents.[32] While legally binding in European member countries, the standards also have international relevance.[31]\n2.1.3.3 International Organization for Standardization (ISO) 10993, 13485, and 16142-2\nAs described in the previous subsection, the ISO 10993 series of standards addresses the biocompatibility of medical device materials, and the standard is worth mentioning here. However, other ISO standards are also relevant. ISO 13485 is the primary quality management system (QMS) standard for hardware- and software-based medical devices and their demonstration of meeting or exceeding customer and regulatory requirements. By meeting the requirements of ISO 13485, the manufacturer facilitates \"an improvement of processes\" within their workflows over the complete lifecycle of operations.[33] ISO 16142-2 \"identifies and describes the six general essential principles of safety and performance ... that apply to all medical devices, including IVD medical devices (in vitro diagnostic),\" while also addressing the safety and performance requirements for designing and manufacturing medical devices.[34]\n2.1.3.4 United States Pharmacopeia and National Formulary (USP-NF) standards\nLike its European counterpart, the USP-NF acts as a compendium of thousands of quality standards for pharmaceutical products and their active and inactive ingredients, helping manufacturers better protect patient safety while also producing higher-quality medicines. Three broad types of standards make up the compendium: monographs, general chapters, and material reference standards. Monographs \"articulate the quality expectations for a medicine\" and \"describe the tests to validate\" the medicine's ability to meet those expectations.[35] General chapters take a broad approach to product development and manufacturing, discussing accepted processes, tests, and methods for pharmaceuticals. Material reference standards complement monographs and general chapters with their quality testing methods to ensure medicines adhere to the state requirements of monographs and general chapters.[35]\n\n2.1.4 Other industries and standards \nFrom our North American Industry Classification System (NAICS)-derived list of manufacturing industries in Chapter 1, we know there's more to manufacturing than food and beverage, materials, and pharmaceuticals and medical devices. Apparel, electronics, furniture, plastics, and petrochemical manufacturers\u2014to name a few\u2014have their own standards. It is beyond the scope of this guide to cover every industry; however, this subsection will highlight a few examples of standards that are applicable to a wide variety of other industries, including the all-important ISO 9001 standard.\n2.1.4.1 British Standards Institution (BSI) standards\nBSI is appointed by the United Kingdom as the national standards body and seeks to \"improve the quality and safety of products, services and systems by enabling the creation of standards and encouraging their use.\"[36] BSI works in tandem with the ISO to address the standards needs of the U.K. Addressed among its standards are the topics of quality, supply chain, health and safety, and automation.[37] An example of a manufacturing standard is BS EN 1090, which addresses \"structural\/construction steel and aluminum products that are installed in a permanent manner.\"[38]\n2.1.4.2 Global Standard's Global Organic Textile Standard (GOTS)\nGlobal Standard's GOTS is described as \"the worldwide leading textile processing standard for organic fibres, including ecological and social criteria, backed up by independent third-party certification of the entire textile supply chain.\"[39] The standard's breadth covers the entire spectrum of textile manufacturing, from design and processing to final distribution. Global Standards also provides an implementation manual for organizations with questions about the standard's implementation.[40]\n2.1.4.3 International Organization for Standardization (ISO) 9001\nISO 9001 specifies the requirements for a QMS within any organization providing products and services, particularly those seeking to prove their products and services consistently meet customer and regulatory requirements and necessarily enhance customer satisfaction.[41] While it does not define product quality, by focusing on the QMS, a manufacturer typically by extension produces products of a higher quality. (Though, broadly speaking, such improvement is partly driven by the fact that there is a tendency for better performing companies to seek ISO 9001 certification.[42]) The standard applies to manufacturers big and small across any industry, and as such, ISO 9001 requires the organization to closely consider its context within its industry and business environment in order to make the most of the standard.[43]\n2.1.4.4 Underwriter Laboratories (UL) standards\nUL says its standards \"are used to assess products; test components, materials, systems and performance; and evaluate environmentally sustainable products, renewable energies, food and water products, recycling systems and other innovative technologies.\"[44] When looking at their catalog of standards, the breadth of products\u2014and therefore industries\u2014becomes more apparent, from electrical conduit, thermostat wiring, energy storage systems, and fire extinguishers to electric gardening devices, elevator door locks and contacts, garment finishing appliances, and gasoline.[45] If it can be manufactured in your industry, UL may have a standard for it.\n\nReferences \n\n\n\u2191 Mor, Rahul S.; Bhardwaj, Arvind; Singh, Sarbjit; Sachdeva, Anish (21 October 2019). \"Productivity gains through standardization-of-work in a manufacturing company\" (in en). Journal of Manufacturing Technology Management 30 (6): 899\u2013919. doi:10.1108\/JMTM-07-2017-0151. ISSN 1741-038X. https:\/\/www.emerald.com\/insight\/content\/doi\/10.1108\/JMTM-07-2017-0151\/full\/html .   \n \n\n\u2191 Allen, Robert H; Sriram, Ram D (1 June 2000). \"The Role of Standards in Innovation\" (in en). Technological Forecasting and Social Change 64 (2-3): 171\u2013181. doi:10.1016\/S0040-1625(99)00104-3. https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0040162599001043 .   \n \n\n\u2191 3.0 3.1 Pavlovi\u0107, A. (26 June 2017). \"What is BRC? Global food safety standard explained\". Ideagen Blog. Ideagen Limited. https:\/\/www.ideagen.com\/thought-leadership\/blog\/what-is-brc-global-food-safety-standard-explained . Retrieved 05 May 2023 .   \n \n\n\u2191 4.0 4.1 4.2 \"BRCGS - British Retail Consortium Global Standard\" (PDF). Perry Johnson Food Safety Consulting, Inc. April 2020. https:\/\/www.pjfsc.com\/Downloads\/BRC-Overview.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 \"Food Safety and Quality Regulations: A Guide to Global Standards\" (PDF). Eagle Product Inspection. May 2019. https:\/\/vertassets.blob.core.windows.net\/download\/45fe7af4\/45fe7af4-0500-4163-bd2b-5dd34e824bfd\/eagle_wp_food_safetyquality_regulations_guide_a4_en.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 British Retail Consortium (August 2018). \"Global Standard Food Safety\" (PDF). British Retail Consortium. https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 7.0 7.1 \"About Codex Alimentarius\". Food and Agricultural Organization. 2022. https:\/\/www.fao.org\/fao-who-codexalimentarius\/about-codex\/en\/#c453333 . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Food laws & regulations\". Food and Agricultural Organization. 2022. https:\/\/www.fao.org\/food-safety\/food-control-systems\/policy-and-legal-frameworks\/food-laws-and-regulations\/en\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Codes of Practice\". Codex Alimentarius. Food and Agricultural Organization. 2022. https:\/\/www.fao.org\/fao-who-codexalimentarius\/codex-texts\/codes-of-practice\/en\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Contaminants\". Codex Alimentarius. Food and Agricultural Organization. 2022. https:\/\/www.fao.org\/fao-who-codexalimentarius\/thematic-areas\/contaminants\/en\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"GFSI Releases New Edition of Benchmarking Requirements\". Global Food Safety Initiative. 28 February 2017. https:\/\/mygfsi.com\/press_releases\/gfsi-releases-new-edition-of-benchmarking-requirements\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Certification\". Global Food Safety Initiative. 2022. https:\/\/mygfsi.com\/how-to-implement\/certification\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 13.0 13.1 13.2 13.3 Weinroth, Margaret D; Belk, Aeriel D; Belk, Keith E (9 November 2018). \"History, development, and current status of food safety systems worldwide\" (in en). Animal Frontiers 8 (4): 9\u201315. doi:10.1093\/af\/vfy016. ISSN 2160-6056. PMC PMC6951898. PMID 32002225. https:\/\/academic.oup.com\/af\/article\/8\/4\/9\/5087923 .   \n \n\n\u2191 \"61 FR 38806 - Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems\". Federal Register. U.S. Government Publishing Office. 25 July 1996. https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary . Retrieved 05 May 2023 .   \n \n\n\u2191 15.0 15.1 \"IFS: Global Safety and Quality Standards\". IFS Management GmbH. https:\/\/www.ifs-certification.com\/en\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"ISO 22000 Food safety management\". International Organization for Standardization. https:\/\/www.iso.org\/iso-22000-food-safety-management.html . Retrieved 05 May 2023 .   \n \n\n\u2191 \"ISO\/TC34\/SC17\". International Organization for Standardization. https:\/\/committee.iso.org\/home\/tc34sc17 . Retrieved 05 May 2023 .   \n \n\n\u2191 \"ISO\/TS 22002-1:2009 Prerequisite programmes on food safety \u2014 Part 1: Food manufacturing\". International Organization for Standardization. December 2009. https:\/\/www.iso.org\/standard\/44001.html . Retrieved 05 May 2023 .   \n \n\n\u2191 \"ISO\/TS 22002-4:2013 Prerequisite programmes on food safety \u2014 Part 4: Food packaging manufacturing\". International Organization for Standardization. December 2013. https:\/\/www.iso.org\/standard\/60969.html . Retrieved 05 May 2023 .   \n \n\n\u2191 \"ISO\/TS 22002-6:2016 Prerequisite programmes on food safety \u2014 Part 6: Feed and animal food production\". International Organization for Standardization. April 2016. https:\/\/www.iso.org\/standard\/66126.html . Retrieved 05 May 2023 .   \n \n\n\u2191 \"SQF Code \u2013 Edition 9 Downloads\". SQF Institute. 24 May 2021. https:\/\/www.sqfi.com\/resource-center\/sqf-code-edition-9-downloads\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 22.0 22.1 \"Materials Science and Engineering - Standards\". UCLA Library Research Guides. UCLA Library. 1 May 2014. https:\/\/guides.library.ucla.edu\/c.php?g=180271&p=1190840 . Retrieved 05 May 2023 .   \n \n\n\u2191 \"ASTM Volume 15.04: Soaps And Other Detergents; Polishes; Leather; Resilient Floor Coverings\". ASTM International. September 2022. https:\/\/www.astm.org\/astm-bos-15.04.html . Retrieved 25 April 2023 .   \n \n\n\u2191 \"A3000-18 Cementitious materials compendium\". CSA Group. 2018. https:\/\/www.csagroup.org\/store\/product\/A3000-18\/ . Retrieved 25 April 2023 .   \n \n\n\u2191 25.0 25.1 25.2 25.3 \"Material standards for medical manufacturing\". Essentra Components. 28 October 2021. https:\/\/www.essentracomponents.com\/en-us\/news\/industries\/medical-equipment\/material-standards-for-medical-manufacturing . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Glossary of Biocompatibility Terms\". U.S. Food and Drug Administration. 18 March 2021. https:\/\/www.fda.gov\/medical-devices\/biocompatibility-assessment-resource-center\/glossary-biocompatibility-terms . Retrieved 05 May 2023 .   \n \n\n\u2191 27.0 27.1 \"Standards\". Metal Powder Industries Federation. 2023. https:\/\/www.mpif.org\/Resources\/Standards.aspx . Retrieved 25 April 2023 .   \n \n\n\u2191 Atouf, Fouad; Venema, Jaap (1 August 2020). \"Do Standards Matter? What is Their Value?\" (in en). Journal of Pharmaceutical Sciences 109 (8): 2387\u20132392. doi:10.1016\/j.xphs.2020.04.017. https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0022354920302409 .   \n \n\n\u2191 Stinshoff, K.E. (2004). \"Role of Standards in the Assessment of Medical Devices\" (PDF). International Organization for Standardization. https:\/\/www.iso.org\/files\/live\/sites\/isoorg\/files\/archive\/pdf\/en\/wsc-medtech_10_klaus_stinshoff_text.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 \"ASTM Volume 14.01: Statistical Methods; Hazard Potential Of Chemicals; Thermal Measurements; Manufacture Of Pharmaceutical And Biopharmaceutical Products; Healthcare Informatics\". ASTM International. June 2022. https:\/\/www.astm.org\/astm-bos-14.01.html . Retrieved 25 April 2023 .   \n \n\n\u2191 31.0 31.1 \"European Pharmacopoeia - Background and Mission\". Council of Europe. https:\/\/www.edqm.eu\/en\/background-and-mission . Retrieved 05 May 2023 .   \n \n\n\u2191 \"European Pharmacopoeia (Ph. Eur.) 11th Edition\". Council of Europe. https:\/\/www.edqm.eu\/en\/european-pharmacopoeia-ph.-eur.-11th-edition . Retrieved 05 May 2023 .   \n \n\n\u2191 Abuhav, Itay (2018). \"1. Scope\". ISO 13485:2016: a complete guide to quality management in the medical device industry (Second edition ed.). Boca Raton London New York: CRC Press, Taylor & Francis Group. pp. 1\u20137. ISBN 978-1-351-00077-2.   \n \n\n\u2191 \"ISO 16142-2:2017 Medical devices \u2014 Recognized essential principles of safety and performance of medical devices \u2014 Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards\". International Organization for Standardization. https:\/\/www.iso.org\/standard\/63940.html . Retrieved 05 May 2023 .   \n \n\n\u2191 35.0 35.1 \"An Overview of USP Monographs\". United States Pharmacopeia. https:\/\/www.usp.org\/about\/public-policy\/overview-of-monographs . Retrieved 05 May 2023 .   \n \n\n\u2191 \"UK national standards body\". British Standards Institution. 2023. https:\/\/www.bsigroup.com\/en-GB\/about-bsi\/uk-national-standards-body\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Manufacturing\". British Standards Institution. 2023. https:\/\/www.bsigroup.com\/en-US\/Industries-and-sectors\/manufacturing-and-processing\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"BS EN 1090 - Structural steel and aluminium\". British Standards Institution. 2023. https:\/\/www.bsigroup.com\/en-GB\/our-services\/product-certification\/ce-mark\/eu-directives\/construction-products-regulation-cpr\/en-1090-structural-steel\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Key Features\". Global Standard GmbH. 2023. https:\/\/global-standard.org\/the-standard\/gots-key-features . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Development and Implementation - Implementation Manual\". Global Standard GmbH. 2023. https:\/\/global-standard.org\/the-standard\/development-and-implementation#manual . Retrieved 05 May 2023 .   \n \n\n\u2191 \"ISO 9001:2015 Quality management systems \u2014 Requirements\". International Organization for Standardization. September 2015. https:\/\/www.iso.org\/standard\/62085.html . Retrieved 05 May 2023 .   \n \n\n\u2191 Heras, I\u00f1aki; Dick, Gavin P.M.; Casades\u00fas, Mart\u00ed (2002). \"ISO 9000 registration's impact on sales and profitability: A longitudinal analysis of performance before and after accreditation\". International Journal of Quality & Reliability Management 19 (6): 774\u2013791. doi:10.1108\/02656710210429618.   \n \n\n\u2191 Abuhav, I. (2017). \"Chapter 4 Context of the Organization\". ISO 9001: 2015 - A Complete Guide to Quality Management Systems. CRC Press. ISBN 9781498733212. https:\/\/books.google.com\/books?id=NmUlDgAAQBAJ&printsec=frontcover .   \n \n\n\u2191 \"About\". Underwriter Laboratories. 2023. https:\/\/ulstandards.ul.com\/about\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Standards & Publications\". Underwriter Laboratories. 2023. https:\/\/www.shopulstandards.com\/Catalog.aspx . Retrieved 05 May 2023 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 21:53.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 3 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","15a608383abc44912e4e0b246caa1a92_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Standards_and_regulations_affecting_manufacturing_labs_Globally_recognized_manufacturing_standards rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Standards_and_regulations_affecting_manufacturing_labs_Globally_recognized_manufacturing_standards skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Standards and regulations affecting manufacturing labs\/Globally recognized manufacturing standards<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h2><span class=\"mw-headline\" id=\"2._Standards_and_regulations_affecting_manufacturing_labs\">2. Standards and regulations affecting manufacturing labs<\/span><\/h2>\n<p>Societies around the world have grown to expect and depend on high-quality products that prove safe to their health, fully functional, and as-advertised. However, all manufacturers have not been equal in striving for and meeting such goals over the years, requiring standardization and regulatory tools to better drive the development and production of safe, high-quality products. As we learned in the previous chapter, manufacturing-based laboratories are critically involved in that manufacturing goal, and as such, those laboratories are in part guided and driven by manufacturing standards and regulations. After all, accurate and timely laboratory results are critical to the processes of research and development (R&D), quality control (QC), and post-production analyses. Naturally, standards and regulations may differ slightly from country to country, which should not be surprising. However, international efforts towards standards harmonization are ongoing as a means to make international trade more productive and to expand quality processes beyond national borders.\n<\/p><p>That said, \"manufacturing\" is a broad realm, as noted at the beginning of Chapter 1. The standards and regulations impacting textile manufacturers, for example, may differ greatly from those applied to pharmaceutical or electric vehicle manufacturers. As such, it's difficult to broadly make statements about standardization and regulation of the manufacturing industries. However, this chapter will attempt to examine some of these aspects from the 30,000 foot view, while focusing on providing examples across multiple manufacturing industries. Here we'll briefly examine the standards, regulations, guidance, and other factors globally driven by not only the demand for safer products, but also that in many cases dictate what and how quality activities are conducted towards ensuring product safety around the world inside and outside the manufacturing-based laboratory.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"2.1_Globally_recognized_manufacturing_standards\">2.1 Globally recognized manufacturing standards<\/span><\/h3>\n<p>Manufacturing industries of all types depend on well-defined and -justified standards to better ensure the quality of their products. Implementing and maintaining conformance to internationally recognized and benchmarked safety and quality standards benefits the manufacturer in a number of ways<sup id=\"rdp-ebb-cite_ref-1\" class=\"reference\"><a href=\"#cite_note-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-2\" class=\"reference\"><a href=\"#cite_note-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Pavlovi.C4.87What17_3-0\" class=\"reference\"><a href=\"#cite_note-Pavlovi.C4.87What17-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PJBRCGS20_4-0\" class=\"reference\"><a href=\"#cite_note-PJBRCGS20-4\">[4]<\/a><\/sup>:\n<\/p>\n<ul><li>It increases customer confidence through the organization's audited certification to the standard, taking the place of customers' own auditing methods to ensure quality and authenticity, in turn reducing time and costs.<\/li>\n<li>It drives organizations to better monitor their activities for non-conformities, identify root causes, and develop preventative controls, while clearly reporting such efforts to customers, further reducing the need for customer audits.<\/li>\n<li>It better ensures a rigorous and comprehensive approach to product safety, quality, integrity, and legality, in many cases meeting or exceeding local, state, federal, and\/or international legislative requirements.<\/li>\n<li>It drives organizations to better vet their suppliers and service providers for meeting required product safety management practices.<\/li>\n<li>It enables organizations to better demonstrate auditable compliance with modern product safety management practices.<\/li>\n<li>It allows organizations to limit product recalls, reduce customer complaints, and better protect their brand.<\/li><\/ul>\n<p>As such, manufacturers adopt standards from one or more organizations around the world, not only to benefit their operations but also meet or exceed regulatory requirements for their industry. What follows are some of the more critical standards and guidelines that apply to a wide variety of manufacturing industries.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.1.1_Food_and_beverage\">2.1.1 Food and beverage<\/span><\/h4>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:FDA_Food_Safety_%26_Applied_Nutrition_Lab_(3830)_(7944692320).jpg\" class=\"image wiki-link\" data-key=\"c658b9db0957ae414c940ba306979762\"><img alt=\"FDA Food Safety & Applied Nutrition Lab (3830) (7944692320).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/b2\/FDA_Food_Safety_%26_Applied_Nutrition_Lab_%283830%29_%287944692320%29.jpg\" decoding=\"async\" width=\"340\" height=\"226\" \/><\/a><\/div><p>Food and beverage researchers and manufacturers adopt standards from one or more organizations around the world, not only to benefit their operations but also meet or exceed regulatory requirements for their industry. What follows are some of the more critical standards and guidelines that apply to the food, beverage, and feed industries.\n<\/p><p><b>2.1.1.1 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)<\/b>\n<\/p><p>In 1998, the <a href=\"https:\/\/en.wikipedia.org\/wiki\/British_Retail_Consortium\" class=\"extiw wiki-link\" title=\"wikipedia:British Retail Consortium\" data-key=\"2703f15b140438dce90dd8e1e0c89fe5\">British Retail Consortium<\/a> (BRD) published the first edition of its Global Standard for Food Safety (GSFS), going on to become an internationally recognized standard of best practices in food manufacturing, storage, and distribution, and the first food safety standard to be recognized by the Global Food Safety Initiative (GFSI; discussed later). The standard covers stakeholder buy-in on continual improvement, food safety plan development, food quality management system development, manufacturing and storage site standardization, product and process control, personnel management, risk management, and trade product management.<sup id=\"rdp-ebb-cite_ref-Pavlovi.C4.87What17_3-1\" class=\"reference\"><a href=\"#cite_note-Pavlovi.C4.87What17-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PJBRCGS20_4-1\" class=\"reference\"><a href=\"#cite_note-PJBRCGS20-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EagleFood19_5-0\" class=\"reference\"><a href=\"#cite_note-EagleFood19-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BRCGSFS8_18_6-0\" class=\"reference\"><a href=\"#cite_note-BRCGSFS8_18-6\">[6]<\/a><\/sup> The standard is implemented by an organization through gap assessment, documentation development, consultation and assessment, internal auditing, and resolving non-conformances to the standard.<sup id=\"rdp-ebb-cite_ref-PJBRCGS20_4-2\" class=\"reference\"><a href=\"#cite_note-PJBRCGS20-4\">[4]<\/a><\/sup> \n<\/p><p><b>2.1.1.2 Codex Alimentarius<\/b>\n<\/p><p>The <a href=\"https:\/\/en.wikipedia.org\/wiki\/Codex_Alimentarius\" class=\"extiw wiki-link\" title=\"wikipedia:Codex Alimentarius\" data-key=\"1226baea981601f720ef734e261c7a4d\">Codex Alimentarius<\/a> is a collection of internationally recognized food and feed standards and guidelines developed as a joint venture between the United Nation's Food and Agricultural Organization (FAO) and the <a href=\"https:\/\/www.limswiki.org\/index.php\/World_Health_Organization\" title=\"World Health Organization\" class=\"wiki-link\" data-key=\"2a49f1470638d5f579e3f6419e239b03\">World Health Organization<\/a> (WHO).<sup id=\"rdp-ebb-cite_ref-EagleFood19_5-1\" class=\"reference\"><a href=\"#cite_note-EagleFood19-5\">[5]<\/a><\/sup> The Codex \"is intended to guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and in doing so to facilitate international trade.\"<sup id=\"rdp-ebb-cite_ref-FAOCodexAbout_7-0\" class=\"reference\"><a href=\"#cite_note-FAOCodexAbout-7\">[7]<\/a><\/sup> Scope of the standards is broad, covering food hygiene; food additives and contaminants, including pesticides and drugs; packaging and labeling; sampling and analysis methods; and import and export inspection and certification.<sup id=\"rdp-ebb-cite_ref-FAOCodexAbout_7-1\" class=\"reference\"><a href=\"#cite_note-FAOCodexAbout-7\">[7]<\/a><\/sup> It's not unusual for governments to approach the FAO seeking help with harmonizing national legal frameworks of food safety with the Codex Alimentarius.<sup id=\"rdp-ebb-cite_ref-FOAFood22_8-0\" class=\"reference\"><a href=\"#cite_note-FOAFood22-8\">[8]<\/a><\/sup> Among the Codex, some of the more broadly useful standards include General Principles of Food Hygiene (CXC 1-1969)<sup id=\"rdp-ebb-cite_ref-FAOCodes22_9-0\" class=\"reference\"><a href=\"#cite_note-FAOCodes22-9\">[9]<\/a><\/sup>, General Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995), and General Methods of Analysis for Contaminants (CXS 228-2001).<sup id=\"rdp-ebb-cite_ref-FAOContam22_10-0\" class=\"reference\"><a href=\"#cite_note-FAOContam22-10\">[10]<\/a><\/sup>\n<\/p><p><b>2.1.1.3 Global Food Safety Initiative (GFSI)<\/b>\n<\/p><p>The <a href=\"https:\/\/en.wikipedia.org\/wiki\/Global_Food_Safety_Initiative\" class=\"extiw wiki-link\" title=\"wikipedia:Global Food Safety Initiative\" data-key=\"7adfea5013c92b34d04ea298fcf6ae00\">GFSI<\/a> is a collection of private organizations that has developed a set of benchmarking requirements for improving food safety management programs, with a goal of making them balanced enough to be broadly applicable while remaining relevant to different countries and regions of the world.<sup id=\"rdp-ebb-cite_ref-EagleFood19_5-2\" class=\"reference\"><a href=\"#cite_note-EagleFood19-5\">[5]<\/a><\/sup> Previously known as the GFSI Guidance Document<sup id=\"rdp-ebb-cite_ref-GFSIRelease17_11-0\" class=\"reference\"><a href=\"#cite_note-GFSIRelease17-11\">[11]<\/a><\/sup>, the GFSI Benchmarking Requirements act as a set of criteria and professional framework for food safety management programs to fulfill, formally allowing an organization to be recognized and certified by the GFSI. Certification to the GFSI Benchmarking Requirements \"demonstrates an organization\u2019s serious commitment to food safety to customers and potential customers across the world.\"<sup id=\"rdp-ebb-cite_ref-EagleFood19_5-3\" class=\"reference\"><a href=\"#cite_note-EagleFood19-5\">[5]<\/a><\/sup> An organization seeks out a third-party certification program owner (CPO) and undergoes the auditing process, which is driven and supported by the GFSI Benchmarking Requirements.<sup id=\"rdp-ebb-cite_ref-GFSICert22_12-0\" class=\"reference\"><a href=\"#cite_note-GFSICert22-12\">[12]<\/a><\/sup> GFSI is also responsible for ensuring CPOs and certification bodies meet the necessary requirements.\n<\/p><p><b>2.1.1.4 Hazard analysis and critical control points (HACCP)<\/b>\n<\/p><p>The <a href=\"https:\/\/en.wikipedia.org\/wiki\/Hazard_analysis_and_critical_control_points\" class=\"extiw wiki-link\" title=\"wikipedia:Hazard analysis and critical control points\" data-key=\"0137420d84e4357942376f94fdbc1d53\">hazard analysis and critical control points<\/a> or HACCP system has been adopted and integrated in various ways over the years<sup id=\"rdp-ebb-cite_ref-WeinrothHist18_13-0\" class=\"reference\"><a href=\"#cite_note-WeinrothHist18-13\">[13]<\/a><\/sup>, but at its core, the system directs organizations to focus on key areas or \"critical control points\" (CCPs) of vulnerability and hazard within the production process and mitigate their impact on overall food safety.<sup id=\"rdp-ebb-cite_ref-EagleFood19_5-4\" class=\"reference\"><a href=\"#cite_note-EagleFood19-5\">[5]<\/a><\/sup> Though the seeds of HACCP go back to the 1970s, it wasn't until the mid-1990s that it began finding its way into formal regulatory structures in the United States, first codified as 9 CFR Parts 304, 308, 310, 320, 327, 381, 416, and 417 in July 1996.<sup id=\"rdp-ebb-cite_ref-WeinrothHist18_13-1\" class=\"reference\"><a href=\"#cite_note-WeinrothHist18-13\">[13]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-61FR38806_14-0\" class=\"reference\"><a href=\"#cite_note-61FR38806-14\">[14]<\/a><\/sup> HACCP also found its way into other standards benchmarked by the GFSI.<sup id=\"rdp-ebb-cite_ref-WeinrothHist18_13-2\" class=\"reference\"><a href=\"#cite_note-WeinrothHist18-13\">[13]<\/a><\/sup> The concept of HACCP has perhaps changed slightly over the years, but the main principles remain<sup id=\"rdp-ebb-cite_ref-EagleFood19_5-5\" class=\"reference\"><a href=\"#cite_note-EagleFood19-5\">[5]<\/a><\/sup>:\n<\/p>\n<ol><li>Conduct a hazard analysis.<\/li>\n<li>Identify CCPs.<\/li>\n<li>Establish critical limits for those CCPs.<\/li>\n<li>Establish monitoring procedures for those CCPs.<\/li>\n<li>Establish corrective action for failed limits.<\/li>\n<li>Establish verification procedures.<\/li>\n<li>Establish record keeping and documentation procedures.<\/li><\/ol>\n<p><b>2.1.1.5 International Featured Standards (IFS)<\/b>\n<\/p><p>The IFS framework is made up of a group of eight food and non-food standards, covering various processes along the food supply chain. IFS Management, who is responsible for the standards, notes that \"IFS does not specify what these processes must look like but merely provides a risk-based assessment\"<sup id=\"rdp-ebb-cite_ref-IFSHome_15-0\" class=\"reference\"><a href=\"#cite_note-IFSHome-15\">[15]<\/a><\/sup> or \"uniform evaluation system\"<sup id=\"rdp-ebb-cite_ref-EagleFood19_5-6\" class=\"reference\"><a href=\"#cite_note-EagleFood19-5\">[5]<\/a><\/sup> for them. Organizations such as food manufacturers and logistics providers can certify to the standards. Some of the more relevant to food and beverage laboratories include IFS Food (for food manufacturers), IFS Global Markets Food (for food retailers), IFS PACsecure 2 (for packaging manufactures), and IFS Global Markets PACsecure (for packaging suppliers).<sup id=\"rdp-ebb-cite_ref-IFSHome_15-1\" class=\"reference\"><a href=\"#cite_note-IFSHome-15\">[15]<\/a><\/sup>\n<\/p><p><b>2.1.1.6 International Organization for Standardization (ISO) 22000<\/b>\n<\/p><p>The <a href=\"https:\/\/en.wikipedia.org\/wiki\/ISO_22000\" class=\"extiw wiki-link\" title=\"wikipedia:ISO 22000\" data-key=\"57c8bd0eb567bfc4bc40143e2f1daf8b\">ISO 22000<\/a> series of standards addresses how a food safety management system should be set up and operated, and how organizations can be certified to the standard by a third-party auditor.<sup id=\"rdp-ebb-cite_ref-ISO22000_16-0\" class=\"reference\"><a href=\"#cite_note-ISO22000-16\">[16]<\/a><\/sup> ISO 22000 is based off the <a href=\"https:\/\/www.limswiki.org\/index.php\/ISO_9000\" title=\"ISO 9000\" class=\"wiki-link\" data-key=\"53ace2d12e80a7d890ce881bc6fe244a\">ISO 9000<\/a> family of <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_management_system\" title=\"Quality management system\" class=\"wiki-link\" data-key=\"dfecf3cd6f18d4a5e9ac49ca360b447d\">quality management system<\/a> standards and, like other standards, incorporates elements of HACCP.<sup id=\"rdp-ebb-cite_ref-WeinrothHist18_13-3\" class=\"reference\"><a href=\"#cite_note-WeinrothHist18-13\">[13]<\/a><\/sup> The standard claims to be advantaged compared to other standards due to its comprehensive applicability across an entire organization, and across the entire food chain.<sup id=\"rdp-ebb-cite_ref-ISO22000Home_17-0\" class=\"reference\"><a href=\"#cite_note-ISO22000Home-17\">[17]<\/a><\/sup> Major standards applicable to manufacturers with laboratories include:\n<\/p>\n<ul><li>ISO\/TS 22002-1:2009 <i>Prerequisite programmes on food safety \u2014 Part 1: Food manufacturing<\/i><sup id=\"rdp-ebb-cite_ref-ISO22002-1_18-0\" class=\"reference\"><a href=\"#cite_note-ISO22002-1-18\">[18]<\/a><\/sup><\/li>\n<li>ISO\/TS 22002-4:2013 <i>Prerequisite programmes on food safety \u2014 Part 4: Food packaging manufacturing<\/i><sup id=\"rdp-ebb-cite_ref-ISO22002-4_19-0\" class=\"reference\"><a href=\"#cite_note-ISO22002-4-19\">[19]<\/a><\/sup><\/li>\n<li>ISO\/TS 22002-6:2016 <i>Prerequisite programmes on food safety \u2014 Part 6: Feed and animal food production<\/i><sup id=\"rdp-ebb-cite_ref-ISO22002-6_20-0\" class=\"reference\"><a href=\"#cite_note-ISO22002-6-20\">[20]<\/a><\/sup><\/li><\/ul>\n<p><b>2.1.1.7 Safe Quality Food (SQF) Program<\/b>\n<\/p><p>The SQF Program, headlined by the SQF Institute and recognized by the GFSI, is a food \"safety-plus-quality\" management certification mechanism that covers the food supply chain from farm to fork.<sup id=\"rdp-ebb-cite_ref-EagleFood19_5-7\" class=\"reference\"><a href=\"#cite_note-EagleFood19-5\">[5]<\/a><\/sup> Those who wish to be certified to SQF must comply with SQF Code, which covers a variety of topics, from aquaculture and farming to food packaging and food and feed manufacturing.<sup id=\"rdp-ebb-cite_ref-SQFCode_21-0\" class=\"reference\"><a href=\"#cite_note-SQFCode-21\">[21]<\/a><\/sup> Like other standards, the organization wanting to be accredited finds a certified third-party auditor to administer program certification.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.1.2_Materials\">2.1.2 Materials<\/span><\/h4>\n<div class=\"floatleft\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Mechanical_Testing_Lab_(5426178594).jpg\" class=\"image wiki-link\" data-key=\"6447303ceda32a74446a78c1ec6e25a3\"><img alt=\"Mechanical Testing Lab (5426178594).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/7\/79\/Mechanical_Testing_Lab_%285426178594%29.jpg\" decoding=\"async\" width=\"250\" height=\"376\" \/><\/a><\/div><p>An internet search for \"materials engineering standards\" reveals dozens of university library research guides discussing what standards are, why they are important to materials science and engineering, and how to find them via the university's library system. Take for example UCLA's Materials Science and Engineering guide and its relatively succinct description of why standards are important to materials scientists<sup id=\"rdp-ebb-cite_ref-UCLAMaterials14_22-0\" class=\"reference\"><a href=\"#cite_note-UCLAMaterials14-22\">[22]<\/a><\/sup>:\n<\/p><blockquote><p>Standards and specifications are described as documents that describe the rules and conditions for how materials and products should be manufactured, defined, measured, tested, and applied. They are used to establish baselines or a minimum level of performance and quality control to ensure that optimal conditions and procedures for the purpose of creating compatibility with products and services from different periods and a range of sources. Specifications have a more limited range of application than standards and generally establish requirements for materials, products, or services. Standards and specifications may be issued by voluntary technical or trade associations, professional societies, national standards bodies, government agencies, or by international organizations ... Standards and specifications are of greatest utility to engineers, scientists, and those working with new innovations.<\/p><\/blockquote>\n<p>UCLA helpfully goes on to describe the types of standards one should expect to find in regards to materials science and engineering, including categorical (e.g., dimension, structure, grade, durability, safety), method-based (e.g., manufacturing, design, operational safety), testing-based (e.g., analyzing, measuring, verifying), term-based (e.g., abbreviations, symbology, preferred units), and design (e.g., execution method, safety conditions) standards.<sup id=\"rdp-ebb-cite_ref-UCLAMaterials14_22-1\" class=\"reference\"><a href=\"#cite_note-UCLAMaterials14-22\">[22]<\/a><\/sup> As such, it would be practically impossible to address all materials-related standards in this guide. However, a small selection of examples is provided to give varying contexts of what materials engineers and manufacturers may need to consider.\n<\/p><p><b>2.1.2.1 American Society of Civil Engineers (ASCE) materials standards<\/b>\n<\/p><p>The ASCE is a professional organization with its own library of standards, including materials standards for engineering. Examples include ASCE\/T&DI\/ICPI 58-16 <i>Structural Design of Interlocking Concrete Pavement for Municipal Streets and Roadways<\/i>, ASCE\/SEI 19-16 <i>Structural Applications of Steel Cables for Buildings<\/i>, and ASCE\/SEI 48-05 <i>Design of Steel Transmission Pole Structures<\/i>. \n<\/p><p><b>2.1.2.2 ASTM International Volume 15.04<\/b>\n<\/p><p>ASTM International has numerous volumes of standards for materials, including Volume 15.04. This volume covers the chemical requirements for soaps and other detergents, the properties of polishes, various properties and test methods of leather, and the properties of floor coverings.<sup id=\"rdp-ebb-cite_ref-ASTMVol15.04_23-0\" class=\"reference\"><a href=\"#cite_note-ASTMVol15.04-23\">[23]<\/a><\/sup>\n<\/p><p><b>2.1.2.3 Canadian Standards Association (CSA) A3000 series<\/b>\n<\/p><p>The CSA produces standards for a variety of materials, including cementitious materials through its A3000 series of standards. These construction materials standards address the basics of cementitious materials, their appropriate test methods, and the equipment best used for those methods.<sup id=\"rdp-ebb-cite_ref-CSAA3000-18_24-0\" class=\"reference\"><a href=\"#cite_note-CSAA3000-18-24\">[24]<\/a><\/sup>\n<\/p><p><b>2.1.2.4 International Organization for Standardization (ISO) 10993<\/b>\n<\/p><p>Generally speaking, there are no ISO or government-sanctioned standards for the materials that can be used in <a href=\"https:\/\/www.limswiki.org\/index.php\/Medical_device\" title=\"Medical device\" class=\"wiki-link\" data-key=\"8e821122daa731f0fa8782fae57831fa\">medical devices<\/a>, but rather there are standards that apply directly to medical devices, largely given that the overall manufacturing process has a tendency to modify the reactivity of the material used in the medical device.<sup id=\"rdp-ebb-cite_ref-ECMaterial21_25-0\" class=\"reference\"><a href=\"#cite_note-ECMaterial21-25\">[25]<\/a><\/sup> That being said, there is an ISO standard for biocompatibility, \"the ability of a device material to perform with an appropriate host response in a specific situation\"<sup id=\"rdp-ebb-cite_ref-FDAGloss21_26-0\" class=\"reference\"><a href=\"#cite_note-FDAGloss21-26\">[26]<\/a><\/sup>: the ISO 10993 series of standards.<sup id=\"rdp-ebb-cite_ref-ECMaterial21_25-1\" class=\"reference\"><a href=\"#cite_note-ECMaterial21-25\">[25]<\/a><\/sup> These standards requires manufacturers of medical devices to collect \"qualitative and quantitative data on the materials in the context of biological safety\" to ensure the device's material is actually biocompatible.<sup id=\"rdp-ebb-cite_ref-ECMaterial21_25-2\" class=\"reference\"><a href=\"#cite_note-ECMaterial21-25\">[25]<\/a><\/sup> ISO 10933 addresses chemical characterization, allowable limits of leachable substances, and <i>in vitro<\/i> cytotoxicity of medical device materials, among other things.<sup id=\"rdp-ebb-cite_ref-ECMaterial21_25-3\" class=\"reference\"><a href=\"#cite_note-ECMaterial21-25\">[25]<\/a><\/sup>\n<\/p><p><b>2.1.2.5 Metal Powder Industries Federation (MPIF) Standard 35 family<\/b>\n<\/p><p>The MPIF \"issues standards to provide the design and materials engineer with the information necessary for specifying powder metallurgy materials which have been developed by the powder metallurgy and metal injection molding parts, powder, and equipment producers.\"<sup id=\"rdp-ebb-cite_ref-MPIFStand23_27-0\" class=\"reference\"><a href=\"#cite_note-MPIFStand23-27\">[27]<\/a><\/sup> Among them is the Standard 35 family, which addresses powder metallurgy structural parts and self-lubricating bearings, as well as powder-forged steel and metal injection molded parts, including materials aspects such as \"minimum strength value, grade selection, chemistry, proof testing, typical property values, and processes.\"<sup id=\"rdp-ebb-cite_ref-MPIFStand23_27-1\" class=\"reference\"><a href=\"#cite_note-MPIFStand23-27\">[27]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.1.3_Pharmaceutical_and_medical_devices\">2.1.3 Pharmaceutical and medical devices<\/span><\/h4>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:A_technician_looks_at_samples_at_the_pharmaceutical_lab_in_Rockville,_Maryland_LCCN2011631564.tif\" class=\"image wiki-link\" data-key=\"df1b842e04f457ae810c79830d70b98a\"><img alt=\"A technician looks at samples at the pharmaceutical lab in Rockville, Maryland LCCN2011631564.tif\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/5\/5c\/A_technician_looks_at_samples_at_the_pharmaceutical_lab_in_Rockville%2C_Maryland_LCCN2011631564.tif\/lossy-page1-250px-A_technician_looks_at_samples_at_the_pharmaceutical_lab_in_Rockville%2C_Maryland_LCCN2011631564.tif.jpg\" decoding=\"async\" width=\"250\" height=\"316\" \/><\/a><\/div><p>Of the various manufacturing domains, pharmaceutical and <a href=\"https:\/\/www.limswiki.org\/index.php\/Medical_device_manufacturing\" title=\"Medical device manufacturing\" class=\"wiki-link\" data-key=\"fbd6a338fbe32db0cf3855d3ae3b7d24\">medical device manufacturing<\/a> arguably requires some of the most rigorous standards to ensure the good health of end users. Speaking to consumer expectations of safe, high-quality pharmaceutical products, Atouf and Venema note<sup id=\"rdp-ebb-cite_ref-28\" class=\"reference\"><a href=\"#cite_note-28\">[28]<\/a><\/sup>:\n<\/p><blockquote><p>The consistency in both the safety and efficacy of the drug supply required to achieve this assurance is based mainly on our reliance on compendial standards for quality and performance of drug development, review, and ongoing manufacturing. These standards are recognized in the [Food, Drug and Cosmetic Act] and play a critical role in its adulteration and misbranding provisions ... The impact of established and accepted standards\u2014in the form of measurements and methods as well as reference materials\u2014being a norm for drug development often goes unnoticed and unmeasured, even by those intimately involved in the field. By the very fact of being the norm, they are taken for granted. Their impact is nonetheless fundamental to the current and future efficiency of drug development as well as to the pursuit of providing safe, high-quality medicines at a reasonable price.<\/p><\/blockquote>\n<p>Similarly, harmonized medical device standards are valuable to manufacturers and end users, making it \"possible to apply essential requirements\" of development and manufacturing \"in a uniform way.\" Manufacturers can adopt harmonized standards in such a way that design and documentation costs are reduced, while at the same time giving end users more confidence in the safety and efficacy of manufactured devices.<sup id=\"rdp-ebb-cite_ref-StinshoffRole04_29-0\" class=\"reference\"><a href=\"#cite_note-StinshoffRole04-29\">[29]<\/a><\/sup>\n<\/p><p>Like materials standards, it's beyond the scope of this guide to try and list all pharmaceutical and medical device standards. What follows are a few examples of more critical standards in this industry.\n<\/p><p><b>2.1.3.1 ASTM International Volume 14.01<\/b>\n<\/p><p>ASTM International covers pharmaceutical and biopharmaceutical manufacturing in its Volume 14.01. In particular, it \"covers the application of process analytical technology (PAT) within the pharmaceutical and biopharmaceutical industry, highlighting PAT system management, implementation, and practices.\"<sup id=\"rdp-ebb-cite_ref-ASTMVol14.01_30-0\" class=\"reference\"><a href=\"#cite_note-ASTMVol14.01-30\">[30]<\/a><\/sup>\n<\/p><p><b>2.1.3.2 European Pharmacopoeia standards<\/b>\n<\/p><p>The European Pharmacopoeia is a compendium of standards\u2014in the form of monographs and other documents\u2014that provides \"a legal and scientific basis for quality control during the development, production and marketing\" of pharmaceuticals and their ingredients. These standards address the compositions, testing, and handling of medicines and their ingredients to better ensure the safety of consumers and a more effective product.<sup id=\"rdp-ebb-cite_ref-EPAbout_31-0\" class=\"reference\"><a href=\"#cite_note-EPAbout-31\">[31]<\/a><\/sup> The eleventh edition contains more than 2,400 monographs, 380 general texts, and 2,800 descriptions of reagents.<sup id=\"rdp-ebb-cite_ref-EPEleventh_32-0\" class=\"reference\"><a href=\"#cite_note-EPEleventh-32\">[32]<\/a><\/sup> While legally binding in European member countries, the standards also have international relevance.<sup id=\"rdp-ebb-cite_ref-EPAbout_31-1\" class=\"reference\"><a href=\"#cite_note-EPAbout-31\">[31]<\/a><\/sup>\n<\/p><p><b>2.1.3.3 International Organization for Standardization (ISO) 10993, 13485, and 16142-2<\/b>\n<\/p><p>As described in the previous subsection, the ISO 10993 series of standards addresses the biocompatibility of medical device materials, and the standard is worth mentioning here. However, other ISO standards are also relevant. ISO 13485 is the primary <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_management_system\" title=\"Quality management system\" class=\"wiki-link\" data-key=\"dfecf3cd6f18d4a5e9ac49ca360b447d\">quality management system<\/a> (QMS) standard for hardware- and software-based medical devices and their demonstration of meeting or exceeding customer and regulatory requirements. By meeting the requirements of ISO 13485, the manufacturer facilitates \"an improvement of processes\" within their workflows over the complete lifecycle of operations.<sup id=\"rdp-ebb-cite_ref-33\" class=\"reference\"><a href=\"#cite_note-33\">[33]<\/a><\/sup> ISO 16142-2 \"identifies and describes the six general essential principles of safety and performance ... that apply to all medical devices, including IVD medical devices (in vitro diagnostic),\" while also addressing the safety and performance requirements for designing and manufacturing medical devices.<sup id=\"rdp-ebb-cite_ref-ISO16142-2_17_34-0\" class=\"reference\"><a href=\"#cite_note-ISO16142-2_17-34\">[34]<\/a><\/sup>\n<\/p><p><b>2.1.3.4 United States Pharmacopeia and National Formulary (USP-NF) standards<\/b>\n<\/p><p>Like its European counterpart, the USP-NF acts as a compendium of thousands of quality standards for pharmaceutical products and their active and inactive ingredients, helping manufacturers better protect patient safety while also producing higher-quality medicines. Three broad types of standards make up the compendium: monographs, general chapters, and material reference standards. Monographs \"articulate the quality expectations for a medicine\" and \"describe the tests to validate\" the medicine's ability to meet those expectations.<sup id=\"rdp-ebb-cite_ref-USPAnOver_35-0\" class=\"reference\"><a href=\"#cite_note-USPAnOver-35\">[35]<\/a><\/sup> General chapters take a broad approach to product development and manufacturing, discussing accepted processes, tests, and methods for pharmaceuticals. Material reference standards complement monographs and general chapters with their quality testing methods to ensure medicines adhere to the state requirements of monographs and general chapters.<sup id=\"rdp-ebb-cite_ref-USPAnOver_35-1\" class=\"reference\"><a href=\"#cite_note-USPAnOver-35\">[35]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.1.4_Other_industries_and_standards\">2.1.4 Other industries and standards<\/span><\/h4>\n<div class=\"floatleft\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:COVID-19-related_research_(49938485863).png\" class=\"image wiki-link\" data-key=\"453420451c76ceee7829956d7ce76f00\"><img alt=\"COVID-19-related research (49938485863).png\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/d\/d4\/COVID-19-related_research_%2849938485863%29.png\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>From our North American Industry Classification System (NAICS)-derived list of manufacturing industries in Chapter 1, we know there's more to manufacturing than food and beverage, materials, and pharmaceuticals and medical devices. Apparel, electronics, furniture, plastics, and petrochemical manufacturers\u2014to name a few\u2014have their own standards. It is beyond the scope of this guide to cover every industry; however, this subsection will highlight a few examples of standards that are applicable to a wide variety of other industries, including the all-important <a href=\"https:\/\/www.limswiki.org\/index.php\/ISO_9000\" title=\"ISO 9000\" class=\"wiki-link\" data-key=\"53ace2d12e80a7d890ce881bc6fe244a\">ISO 9001<\/a> standard.\n<\/p><p><b>2.1.4.1 British Standards Institution (BSI) standards<\/b>\n<\/p><p>BSI is appointed by the United Kingdom as the national standards body and seeks to \"improve the quality and safety of products, services and systems by enabling the creation of standards and encouraging their use.\"<sup id=\"rdp-ebb-cite_ref-BSIAbout_36-0\" class=\"reference\"><a href=\"#cite_note-BSIAbout-36\">[36]<\/a><\/sup> BSI works in tandem with the ISO to address the standards needs of the U.K. Addressed among its standards are the topics of quality, supply chain, health and safety, and automation.<sup id=\"rdp-ebb-cite_ref-BSIManu_37-0\" class=\"reference\"><a href=\"#cite_note-BSIManu-37\">[37]<\/a><\/sup> An example of a manufacturing standard is BS EN 1090, which addresses \"structural\/construction steel and aluminum products that are installed in a permanent manner.\"<sup id=\"rdp-ebb-cite_ref-BSIBSEN1090_38-0\" class=\"reference\"><a href=\"#cite_note-BSIBSEN1090-38\">[38]<\/a><\/sup>\n<\/p><p><b>2.1.4.2 Global Standard's Global Organic Textile Standard (GOTS)<\/b>\n<\/p><p>Global Standard's GOTS is described as \"the worldwide leading textile processing standard for organic fibres, including ecological and social criteria, backed up by independent third-party certification of the entire textile supply chain.\"<sup id=\"rdp-ebb-cite_ref-GSGOTS_39-0\" class=\"reference\"><a href=\"#cite_note-GSGOTS-39\">[39]<\/a><\/sup> The standard's breadth covers the entire spectrum of textile manufacturing, from design and processing to final distribution. Global Standards also provides an implementation manual for organizations with questions about the standard's implementation.<sup id=\"rdp-ebb-cite_ref-GOTSMan_40-0\" class=\"reference\"><a href=\"#cite_note-GOTSMan-40\">[40]<\/a><\/sup>\n<\/p><p><b>2.1.4.3 International Organization for Standardization (ISO) 9001<\/b>\n<\/p><p>ISO 9001 specifies the requirements for a QMS within any organization providing products and services, particularly those seeking to prove their products and services consistently meet customer and regulatory requirements and necessarily enhance customer satisfaction.<sup id=\"rdp-ebb-cite_ref-ISO9001_15_41-0\" class=\"reference\"><a href=\"#cite_note-ISO9001_15-41\">[41]<\/a><\/sup> While it does not define product quality, by focusing on the QMS, a manufacturer typically by extension produces products of a higher quality. (Though, broadly speaking, such improvement is partly driven by the fact that there is a tendency for better performing companies to seek ISO 9001 certification.<sup id=\"rdp-ebb-cite_ref-Heras_42-0\" class=\"reference\"><a href=\"#cite_note-Heras-42\">[42]<\/a><\/sup>) The standard applies to manufacturers big and small across any industry, and as such, ISO 9001 requires the organization to closely consider its context within its industry and business environment in order to make the most of the standard.<sup id=\"rdp-ebb-cite_ref-43\" class=\"reference\"><a href=\"#cite_note-43\">[43]<\/a><\/sup>\n<\/p><p><b>2.1.4.4 Underwriter Laboratories (UL) standards<\/b>\n<\/p><p>UL says its standards \"are used to assess products; test components, materials, systems and performance; and evaluate environmentally sustainable products, renewable energies, food and water products, recycling systems and other innovative technologies.\"<sup id=\"rdp-ebb-cite_ref-ULAbout_44-0\" class=\"reference\"><a href=\"#cite_note-ULAbout-44\">[44]<\/a><\/sup> When looking at their catalog of standards, the breadth of products\u2014and therefore industries\u2014becomes more apparent, from electrical conduit, thermostat wiring, energy storage systems, and fire extinguishers to electric gardening devices, elevator door locks and contacts, garment finishing appliances, and gasoline.<sup id=\"rdp-ebb-cite_ref-ULStandardsCat_45-0\" class=\"reference\"><a href=\"#cite_note-ULStandardsCat-45\">[45]<\/a><\/sup> If it can be manufactured in your industry, UL may have a standard for it.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-1\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Mor, Rahul S.; Bhardwaj, Arvind; Singh, Sarbjit; Sachdeva, Anish (21 October 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.emerald.com\/insight\/content\/doi\/10.1108\/JMTM-07-2017-0151\/full\/html\" target=\"_blank\">\"Productivity gains through standardization-of-work in a manufacturing company\"<\/a> (in en). <i>Journal of Manufacturing Technology Management<\/i> <b>30<\/b> (6): 899\u2013919. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1108%2FJMTM-07-2017-0151\" target=\"_blank\">10.1108\/JMTM-07-2017-0151<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" data-key=\"a5dec3e4d005e654c29ad167ab53f53a\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/issn\/1741-038X\" target=\"_blank\">1741-038X<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.emerald.com\/insight\/content\/doi\/10.1108\/JMTM-07-2017-0151\/full\/html\" target=\"_blank\">https:\/\/www.emerald.com\/insight\/content\/doi\/10.1108\/JMTM-07-2017-0151\/full\/html<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Productivity+gains+through+standardization-of-work+in+a+manufacturing+company&rft.jtitle=Journal+of+Manufacturing+Technology+Management&rft.aulast=Mor&rft.aufirst=Rahul+S.&rft.au=Mor%2C%26%2332%3BRahul+S.&rft.au=Bhardwaj%2C%26%2332%3BArvind&rft.au=Singh%2C%26%2332%3BSarbjit&rft.au=Sachdeva%2C%26%2332%3BAnish&rft.date=21+October+2019&rft.volume=30&rft.issue=6&rft.pages=899%E2%80%93919&rft_id=info:doi\/10.1108%2FJMTM-07-2017-0151&rft.issn=1741-038X&rft_id=https%3A%2F%2Fwww.emerald.com%2Finsight%2Fcontent%2Fdoi%2F10.1108%2FJMTM-07-2017-0151%2Ffull%2Fhtml&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-2\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Allen, Robert H; Sriram, Ram D (1 June 2000). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0040162599001043\" target=\"_blank\">\"The Role of Standards in Innovation\"<\/a> (in en). <i>Technological Forecasting and Social Change<\/i> <b>64<\/b> (2-3): 171\u2013181. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2FS0040-1625%2899%2900104-3\" target=\"_blank\">10.1016\/S0040-1625(99)00104-3<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0040162599001043\" target=\"_blank\">https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0040162599001043<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Role+of+Standards+in+Innovation&rft.jtitle=Technological+Forecasting+and+Social+Change&rft.aulast=Allen&rft.aufirst=Robert+H&rft.au=Allen%2C%26%2332%3BRobert+H&rft.au=Sriram%2C%26%2332%3BRam+D&rft.date=1+June+2000&rft.volume=64&rft.issue=2-3&rft.pages=171%E2%80%93181&rft_id=info:doi\/10.1016%2FS0040-1625%2899%2900104-3&rft_id=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS0040162599001043&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Pavlovi.C4.87What17-3\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-Pavlovi.C4.87What17_3-0\">3.0<\/a><\/sup> <sup><a href=\"#cite_ref-Pavlovi.C4.87What17_3-1\">3.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pavlovi\u0107, A. (26 June 2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ideagen.com\/thought-leadership\/blog\/what-is-brc-global-food-safety-standard-explained\" target=\"_blank\">\"What is BRC? Global food safety standard explained\"<\/a>. <i>Ideagen Blog<\/i>. Ideagen Limited<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.ideagen.com\/thought-leadership\/blog\/what-is-brc-global-food-safety-standard-explained\" target=\"_blank\">https:\/\/www.ideagen.com\/thought-leadership\/blog\/what-is-brc-global-food-safety-standard-explained<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=What+is+BRC%3F+Global+food+safety+standard+explained&rft.atitle=Ideagen+Blog&rft.aulast=Pavlovi%C4%87%2C+A.&rft.au=Pavlovi%C4%87%2C+A.&rft.date=26+June+2017&rft.pub=Ideagen+Limited&rft_id=https%3A%2F%2Fwww.ideagen.com%2Fthought-leadership%2Fblog%2Fwhat-is-brc-global-food-safety-standard-explained&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PJBRCGS20-4\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-PJBRCGS20_4-0\">4.0<\/a><\/sup> <sup><a href=\"#cite_ref-PJBRCGS20_4-1\">4.1<\/a><\/sup> <sup><a href=\"#cite_ref-PJBRCGS20_4-2\">4.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pjfsc.com\/Downloads\/BRC-Overview.pdf\" target=\"_blank\">\"BRCGS - British Retail Consortium Global Standard\"<\/a> (PDF). Perry Johnson Food Safety Consulting, Inc. April 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.pjfsc.com\/Downloads\/BRC-Overview.pdf\" target=\"_blank\">https:\/\/www.pjfsc.com\/Downloads\/BRC-Overview.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=BRCGS+-+British+Retail+Consortium+Global+Standard&rft.atitle=&rft.date=April+2020&rft.pub=Perry+Johnson+Food+Safety+Consulting%2C+Inc&rft_id=https%3A%2F%2Fwww.pjfsc.com%2FDownloads%2FBRC-Overview.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-EagleFood19-5\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-EagleFood19_5-0\">5.0<\/a><\/sup> <sup><a href=\"#cite_ref-EagleFood19_5-1\">5.1<\/a><\/sup> <sup><a href=\"#cite_ref-EagleFood19_5-2\">5.2<\/a><\/sup> <sup><a href=\"#cite_ref-EagleFood19_5-3\">5.3<\/a><\/sup> <sup><a href=\"#cite_ref-EagleFood19_5-4\">5.4<\/a><\/sup> <sup><a href=\"#cite_ref-EagleFood19_5-5\">5.5<\/a><\/sup> <sup><a href=\"#cite_ref-EagleFood19_5-6\">5.6<\/a><\/sup> <sup><a href=\"#cite_ref-EagleFood19_5-7\">5.7<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vertassets.blob.core.windows.net\/download\/45fe7af4\/45fe7af4-0500-4163-bd2b-5dd34e824bfd\/eagle_wp_food_safetyquality_regulations_guide_a4_en.pdf\" target=\"_blank\">\"Food Safety and Quality Regulations: A Guide to Global Standards\"<\/a> (PDF). 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Food+Safety+and+Quality+Regulations%3A+A+Guide+to+Global+Standards&rft.atitle=&rft.date=May+2019&rft.pub=Eagle+Product+Inspection&rft_id=https%3A%2F%2Fvertassets.blob.core.windows.net%2Fdownload%2F45fe7af4%2F45fe7af4-0500-4163-bd2b-5dd34e824bfd%2Feagle_wp_food_safetyquality_regulations_guide_a4_en.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BRCGSFS8_18-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BRCGSFS8_18_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">British Retail Consortium (August 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">\"Global Standard Food Safety\"<\/a> (PDF). 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Food+laws+%26+regulations&rft.atitle=&rft.date=2022&rft.pub=Food+and+Agricultural+Organization&rft_id=https%3A%2F%2Fwww.fao.org%2Ffood-safety%2Ffood-control-systems%2Fpolicy-and-legal-frameworks%2Ffood-laws-and-regulations%2Fen%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FAOCodes22-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FAOCodes22_9-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/codex-texts\/codes-of-practice\/en\/\" target=\"_blank\">\"Codes of Practice\"<\/a>. <i>Codex Alimentarius<\/i>. Food and Agricultural Organization. 2022<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/codex-texts\/codes-of-practice\/en\/\" target=\"_blank\">https:\/\/www.fao.org\/fao-who-codexalimentarius\/codex-texts\/codes-of-practice\/en\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Codes+of+Practice&rft.atitle=Codex+Alimentarius&rft.date=2022&rft.pub=Food+and+Agricultural+Organization&rft_id=https%3A%2F%2Fwww.fao.org%2Ffao-who-codexalimentarius%2Fcodex-texts%2Fcodes-of-practice%2Fen%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FAOContam22-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FAOContam22_10-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/thematic-areas\/contaminants\/en\/\" target=\"_blank\">\"Contaminants\"<\/a>. <i>Codex Alimentarius<\/i>. 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Contaminants&rft.atitle=Codex+Alimentarius&rft.date=2022&rft.pub=Food+and+Agricultural+Organization&rft_id=https%3A%2F%2Fwww.fao.org%2Ffao-who-codexalimentarius%2Fthematic-areas%2Fcontaminants%2Fen%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GFSIRelease17-11\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GFSIRelease17_11-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/press_releases\/gfsi-releases-new-edition-of-benchmarking-requirements\/\" target=\"_blank\">\"GFSI Releases New Edition of Benchmarking Requirements\"<\/a>. 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=GFSI+Releases+New+Edition+of+Benchmarking+Requirements&rft.atitle=&rft.date=28+February+2017&rft.pub=Global+Food+Safety+Initiative&rft_id=https%3A%2F%2Fmygfsi.com%2Fpress_releases%2Fgfsi-releases-new-edition-of-benchmarking-requirements%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GFSICert22-12\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GFSICert22_12-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/how-to-implement\/certification\/\" target=\"_blank\">\"Certification\"<\/a>. 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Certification&rft.atitle=&rft.date=2022&rft.pub=Global+Food+Safety+Initiative&rft_id=https%3A%2F%2Fmygfsi.com%2Fhow-to-implement%2Fcertification%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WeinrothHist18-13\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-WeinrothHist18_13-0\">13.0<\/a><\/sup> <sup><a href=\"#cite_ref-WeinrothHist18_13-1\">13.1<\/a><\/sup> <sup><a href=\"#cite_ref-WeinrothHist18_13-2\">13.2<\/a><\/sup> <sup><a href=\"#cite_ref-WeinrothHist18_13-3\">13.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Weinroth, Margaret D; Belk, Aeriel D; Belk, Keith E (9 November 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/academic.oup.com\/af\/article\/8\/4\/9\/5087923\" target=\"_blank\">\"History, development, and current status of food safety systems worldwide\"<\/a> (in en). <i>Animal Frontiers<\/i> <b>8<\/b> (4): 9\u201315. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1093%2Faf%2Fvfy016\" target=\"_blank\">10.1093\/af\/vfy016<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" data-key=\"a5dec3e4d005e654c29ad167ab53f53a\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/issn\/2160-6056\" target=\"_blank\">2160-6056<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6951898\/\" target=\"_blank\">PMC6951898<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32002225\" target=\"_blank\">32002225<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/academic.oup.com\/af\/article\/8\/4\/9\/5087923\" target=\"_blank\">https:\/\/academic.oup.com\/af\/article\/8\/4\/9\/5087923<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=History%2C+development%2C+and+current+status+of+food+safety+systems+worldwide&rft.jtitle=Animal+Frontiers&rft.aulast=Weinroth&rft.aufirst=Margaret+D&rft.au=Weinroth%2C%26%2332%3BMargaret+D&rft.au=Belk%2C%26%2332%3BAeriel+D&rft.au=Belk%2C%26%2332%3BKeith+E&rft.date=9+November+2018&rft.volume=8&rft.issue=4&rft.pages=9%E2%80%9315&rft_id=info:doi\/10.1093%2Faf%2Fvfy016&rft.issn=2160-6056&rft_id=info:pmc\/PMC6951898&rft_id=info:pmid\/32002225&rft_id=https%3A%2F%2Facademic.oup.com%2Faf%2Farticle%2F8%2F4%2F9%2F5087923&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-61FR38806-14\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-61FR38806_14-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">\"61 FR 38806 - Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems\"<\/a>. <i>Federal Register<\/i>. 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=SQF+Code+%E2%80%93+Edition+9+Downloads&rft.atitle=&rft.date=24+May+2021&rft.pub=SQF+Institute&rft_id=https%3A%2F%2Fwww.sqfi.com%2Fresource-center%2Fsqf-code-edition-9-downloads%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-UCLAMaterials14-22\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-UCLAMaterials14_22-0\">22.0<\/a><\/sup> <sup><a href=\"#cite_ref-UCLAMaterials14_22-1\">22.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/guides.library.ucla.edu\/c.php?g=180271&p=1190840\" target=\"_blank\">\"Materials Science and Engineering - Standards\"<\/a>. <i>UCLA Library Research Guides<\/i>. UCLA Library. 1 May 2014<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/guides.library.ucla.edu\/c.php?g=180271&p=1190840\" target=\"_blank\">https:\/\/guides.library.ucla.edu\/c.php?g=180271&p=1190840<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Materials+Science+and+Engineering+-+Standards&rft.atitle=UCLA+Library+Research+Guides&rft.date=1+May+2014&rft.pub=UCLA+Library&rft_id=https%3A%2F%2Fguides.library.ucla.edu%2Fc.php%3Fg%3D180271%26p%3D1190840&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ASTMVol15.04-23\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ASTMVol15.04_23-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/astm-bos-15.04.html\" target=\"_blank\">\"ASTM Volume 15.04: Soaps And Other Detergents; Polishes; Leather; Resilient Floor Coverings\"<\/a>. ASTM International. September 2022<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.astm.org\/astm-bos-15.04.html\" target=\"_blank\">https:\/\/www.astm.org\/astm-bos-15.04.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 25 April 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ASTM+Volume+15.04%3A+Soaps+And+Other+Detergents%3B+Polishes%3B+Leather%3B+Resilient+Floor+Coverings&rft.atitle=&rft.date=September+2022&rft.pub=ASTM+International&rft_id=https%3A%2F%2Fwww.astm.org%2Fastm-bos-15.04.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CSAA3000-18-24\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CSAA3000-18_24-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.csagroup.org\/store\/product\/A3000-18\/\" target=\"_blank\">\"A3000-18 Cementitious materials compendium\"<\/a>. CSA Group. 2018<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.csagroup.org\/store\/product\/A3000-18\/\" target=\"_blank\">https:\/\/www.csagroup.org\/store\/product\/A3000-18\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 25 April 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=A3000-18+Cementitious+materials+compendium&rft.atitle=&rft.date=2018&rft.pub=CSA+Group&rft_id=https%3A%2F%2Fwww.csagroup.org%2Fstore%2Fproduct%2FA3000-18%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ECMaterial21-25\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ECMaterial21_25-0\">25.0<\/a><\/sup> <sup><a href=\"#cite_ref-ECMaterial21_25-1\">25.1<\/a><\/sup> <sup><a href=\"#cite_ref-ECMaterial21_25-2\">25.2<\/a><\/sup> <sup><a href=\"#cite_ref-ECMaterial21_25-3\">25.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.essentracomponents.com\/en-us\/news\/industries\/medical-equipment\/material-standards-for-medical-manufacturing\" target=\"_blank\">\"Material standards for medical manufacturing\"<\/a>. Essentra Components. 28 October 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.essentracomponents.com\/en-us\/news\/industries\/medical-equipment\/material-standards-for-medical-manufacturing\" target=\"_blank\">https:\/\/www.essentracomponents.com\/en-us\/news\/industries\/medical-equipment\/material-standards-for-medical-manufacturing<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Material+standards+for+medical+manufacturing&rft.atitle=&rft.date=28+October+2021&rft.pub=Essentra+Components&rft_id=https%3A%2F%2Fwww.essentracomponents.com%2Fen-us%2Fnews%2Findustries%2Fmedical-equipment%2Fmaterial-standards-for-medical-manufacturing&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FDAGloss21-26\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FDAGloss21_26-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/medical-devices\/biocompatibility-assessment-resource-center\/glossary-biocompatibility-terms\" target=\"_blank\">\"Glossary of Biocompatibility Terms\"<\/a>. U.S. Food and Drug Administration. 18 March 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fda.gov\/medical-devices\/biocompatibility-assessment-resource-center\/glossary-biocompatibility-terms\" target=\"_blank\">https:\/\/www.fda.gov\/medical-devices\/biocompatibility-assessment-resource-center\/glossary-biocompatibility-terms<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Glossary+of+Biocompatibility+Terms&rft.atitle=&rft.date=18+March+2021&rft.pub=U.S.+Food+and+Drug+Administration&rft_id=https%3A%2F%2Fwww.fda.gov%2Fmedical-devices%2Fbiocompatibility-assessment-resource-center%2Fglossary-biocompatibility-terms&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MPIFStand23-27\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-MPIFStand23_27-0\">27.0<\/a><\/sup> <sup><a href=\"#cite_ref-MPIFStand23_27-1\">27.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mpif.org\/Resources\/Standards.aspx\" target=\"_blank\">\"Standards\"<\/a>. Metal Powder Industries Federation. 2023<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.mpif.org\/Resources\/Standards.aspx\" target=\"_blank\">https:\/\/www.mpif.org\/Resources\/Standards.aspx<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 25 April 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Standards&rft.atitle=&rft.date=2023&rft.pub=Metal+Powder+Industries+Federation&rft_id=https%3A%2F%2Fwww.mpif.org%2FResources%2FStandards.aspx&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-28\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-28\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Atouf, Fouad; Venema, Jaap (1 August 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0022354920302409\" target=\"_blank\">\"Do Standards Matter? What is Their Value?\"<\/a> (in en). <i>Journal of Pharmaceutical Sciences<\/i> <b>109<\/b> (8): 2387\u20132392. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.xphs.2020.04.017\" target=\"_blank\">10.1016\/j.xphs.2020.04.017<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0022354920302409\" target=\"_blank\">https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0022354920302409<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Do+Standards+Matter%3F+What+is+Their+Value%3F&rft.jtitle=Journal+of+Pharmaceutical+Sciences&rft.aulast=Atouf&rft.aufirst=Fouad&rft.au=Atouf%2C%26%2332%3BFouad&rft.au=Venema%2C%26%2332%3BJaap&rft.date=1+August+2020&rft.volume=109&rft.issue=8&rft.pages=2387%E2%80%932392&rft_id=info:doi\/10.1016%2Fj.xphs.2020.04.017&rft_id=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS0022354920302409&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-StinshoffRole04-29\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-StinshoffRole04_29-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Stinshoff, K.E. (2004). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/files\/live\/sites\/isoorg\/files\/archive\/pdf\/en\/wsc-medtech_10_klaus_stinshoff_text.pdf\" target=\"_blank\">\"Role of Standards in the Assessment of Medical Devices\"<\/a> (PDF). International Organization for Standardization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.iso.org\/files\/live\/sites\/isoorg\/files\/archive\/pdf\/en\/wsc-medtech_10_klaus_stinshoff_text.pdf\" target=\"_blank\">https:\/\/www.iso.org\/files\/live\/sites\/isoorg\/files\/archive\/pdf\/en\/wsc-medtech_10_klaus_stinshoff_text.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Role+of+Standards+in+the+Assessment+of+Medical+Devices&rft.atitle=&rft.aulast=Stinshoff%2C+K.E.&rft.au=Stinshoff%2C+K.E.&rft.date=2004&rft.pub=International+Organization+for+Standardization&rft_id=https%3A%2F%2Fwww.iso.org%2Ffiles%2Flive%2Fsites%2Fisoorg%2Ffiles%2Farchive%2Fpdf%2Fen%2Fwsc-medtech_10_klaus_stinshoff_text.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ASTMVol14.01-30\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ASTMVol14.01_30-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/astm-bos-14.01.html\" target=\"_blank\">\"ASTM Volume 14.01: Statistical Methods; Hazard Potential Of Chemicals; Thermal Measurements; Manufacture Of Pharmaceutical And Biopharmaceutical Products; Healthcare Informatics\"<\/a>. ASTM International. June 2022<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.astm.org\/astm-bos-14.01.html\" target=\"_blank\">https:\/\/www.astm.org\/astm-bos-14.01.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 25 April 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ASTM+Volume+14.01%3A+Statistical+Methods%3B+Hazard+Potential+Of+Chemicals%3B+Thermal+Measurements%3B+Manufacture+Of+Pharmaceutical+And+Biopharmaceutical+Products%3B+Healthcare+Informatics&rft.atitle=&rft.date=June+2022&rft.pub=ASTM+International&rft_id=https%3A%2F%2Fwww.astm.org%2Fastm-bos-14.01.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-EPAbout-31\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-EPAbout_31-0\">31.0<\/a><\/sup> <sup><a href=\"#cite_ref-EPAbout_31-1\">31.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.edqm.eu\/en\/background-and-mission\" target=\"_blank\">\"European Pharmacopoeia - Background and Mission\"<\/a>. Council of Europe<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.edqm.eu\/en\/background-and-mission\" target=\"_blank\">https:\/\/www.edqm.eu\/en\/background-and-mission<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=European+Pharmacopoeia+-+Background+and+Mission&rft.atitle=&rft.pub=Council+of+Europe&rft_id=https%3A%2F%2Fwww.edqm.eu%2Fen%2Fbackground-and-mission&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-EPEleventh-32\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EPEleventh_32-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.edqm.eu\/en\/european-pharmacopoeia-ph.-eur.-11th-edition\" target=\"_blank\">\"European Pharmacopoeia (Ph. Eur.) 11th Edition\"<\/a>. Council of Europe<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.edqm.eu\/en\/european-pharmacopoeia-ph.-eur.-11th-edition\" target=\"_blank\">https:\/\/www.edqm.eu\/en\/european-pharmacopoeia-ph.-eur.-11th-edition<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=European+Pharmacopoeia+%28Ph.+Eur.%29+11th+Edition&rft.atitle=&rft.pub=Council+of+Europe&rft_id=https%3A%2F%2Fwww.edqm.eu%2Fen%2Feuropean-pharmacopoeia-ph.-eur.-11th-edition&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-33\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-33\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Abuhav, Itay (2018). \"1. Scope\". <i>ISO 13485:2016: a complete guide to quality management in the medical device industry<\/i> (Second edition ed.). Boca Raton London New York: CRC Press, Taylor & Francis Group. pp. 1\u20137. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-1-351-00077-2.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=1.+Scope&rft.atitle=ISO+13485%3A2016%3A+a+complete+guide+to+quality+management+in+the+medical+device+industry&rft.aulast=Abuhav&rft.aufirst=Itay&rft.au=Abuhav%2C%26%2332%3BItay&rft.date=2018&rft.pages=pp.%26nbsp%3B1%E2%80%937&rft.edition=Second+edition&rft.place=Boca+Raton+London+New+York&rft.pub=CRC+Press%2C+Taylor+%26+Francis+Group&rft.isbn=978-1-351-00077-2&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ISO16142-2_17-34\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ISO16142-2_17_34-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/63940.html\" target=\"_blank\">\"ISO 16142-2:2017 Medical devices \u2014 Recognized essential principles of safety and performance of medical devices \u2014 Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards\"<\/a>. International Organization for Standardization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.iso.org\/standard\/63940.html\" target=\"_blank\">https:\/\/www.iso.org\/standard\/63940.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ISO+16142-2%3A2017+Medical+devices+%E2%80%94+Recognized+essential+principles+of+safety+and+performance+of+medical+devices+%E2%80%94+Part+2%3A+General+essential+principles+and+additional+specific+essential+principles+for+all+IVD+medical+devices+and+guidance+on+the+selection+of+standards&rft.atitle=&rft.pub=International+Organization+for+Standardization&rft_id=https%3A%2F%2Fwww.iso.org%2Fstandard%2F63940.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-USPAnOver-35\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-USPAnOver_35-0\">35.0<\/a><\/sup> <sup><a href=\"#cite_ref-USPAnOver_35-1\">35.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.usp.org\/about\/public-policy\/overview-of-monographs\" target=\"_blank\">\"An Overview of USP Monographs\"<\/a>. United States Pharmacopeia<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.usp.org\/about\/public-policy\/overview-of-monographs\" target=\"_blank\">https:\/\/www.usp.org\/about\/public-policy\/overview-of-monographs<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=An+Overview+of+USP+Monographs&rft.atitle=&rft.pub=United+States+Pharmacopeia&rft_id=https%3A%2F%2Fwww.usp.org%2Fabout%2Fpublic-policy%2Foverview-of-monographs&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BSIAbout-36\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BSIAbout_36-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bsigroup.com\/en-GB\/about-bsi\/uk-national-standards-body\/\" target=\"_blank\">\"UK national standards body\"<\/a>. British Standards Institution. 2023<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.bsigroup.com\/en-GB\/about-bsi\/uk-national-standards-body\/\" target=\"_blank\">https:\/\/www.bsigroup.com\/en-GB\/about-bsi\/uk-national-standards-body\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=UK+national+standards+body&rft.atitle=&rft.date=2023&rft.pub=British+Standards+Institution&rft_id=https%3A%2F%2Fwww.bsigroup.com%2Fen-GB%2Fabout-bsi%2Fuk-national-standards-body%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BSIManu-37\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BSIManu_37-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bsigroup.com\/en-US\/Industries-and-sectors\/manufacturing-and-processing\/\" target=\"_blank\">\"Manufacturing\"<\/a>. British Standards Institution. 2023<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.bsigroup.com\/en-US\/Industries-and-sectors\/manufacturing-and-processing\/\" target=\"_blank\">https:\/\/www.bsigroup.com\/en-US\/Industries-and-sectors\/manufacturing-and-processing\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Manufacturing&rft.atitle=&rft.date=2023&rft.pub=British+Standards+Institution&rft_id=https%3A%2F%2Fwww.bsigroup.com%2Fen-US%2FIndustries-and-sectors%2Fmanufacturing-and-processing%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BSIBSEN1090-38\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BSIBSEN1090_38-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bsigroup.com\/en-GB\/our-services\/product-certification\/ce-mark\/eu-directives\/construction-products-regulation-cpr\/en-1090-structural-steel\/\" target=\"_blank\">\"BS EN 1090 - Structural steel and aluminium\"<\/a>. British Standards Institution. 2023<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.bsigroup.com\/en-GB\/our-services\/product-certification\/ce-mark\/eu-directives\/construction-products-regulation-cpr\/en-1090-structural-steel\/\" target=\"_blank\">https:\/\/www.bsigroup.com\/en-GB\/our-services\/product-certification\/ce-mark\/eu-directives\/construction-products-regulation-cpr\/en-1090-structural-steel\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=BS+EN+1090+-+Structural+steel+and+aluminium&rft.atitle=&rft.date=2023&rft.pub=British+Standards+Institution&rft_id=https%3A%2F%2Fwww.bsigroup.com%2Fen-GB%2Four-services%2Fproduct-certification%2Fce-mark%2Feu-directives%2Fconstruction-products-regulation-cpr%2Fen-1090-structural-steel%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GSGOTS-39\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GSGOTS_39-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/global-standard.org\/the-standard\/gots-key-features\" target=\"_blank\">\"Key Features\"<\/a>. Global Standard GmbH. 2023<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/global-standard.org\/the-standard\/gots-key-features\" target=\"_blank\">https:\/\/global-standard.org\/the-standard\/gots-key-features<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Key+Features&rft.atitle=&rft.date=2023&rft.pub=Global+Standard+GmbH&rft_id=https%3A%2F%2Fglobal-standard.org%2Fthe-standard%2Fgots-key-features&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GOTSMan-40\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GOTSMan_40-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"nofollow\" class=\"external text\" href=\"#manual\">\"Development and Implementation - Implementation Manual\"<\/a>. Global Standard GmbH. 2023<span class=\"printonly\">. <a rel=\"nofollow\" class=\"external free\" href=\"#manual\">https:\/\/global-standard.org\/the-standard\/development-and-implementation#manual<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Development+and+Implementation+-+Implementation+Manual&rft.atitle=&rft.date=2023&rft.pub=Global+Standard+GmbH&rft_id=https%3A%2F%2Fglobal-standard.org%2Fthe-standard%2Fdevelopment-and-implementation%23manual&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ISO9001_15-41\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ISO9001_15_41-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/62085.html\" target=\"_blank\">\"ISO 9001:2015 Quality management systems \u2014 Requirements\"<\/a>. International Organization for Standardization. September 2015<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.iso.org\/standard\/62085.html\" target=\"_blank\">https:\/\/www.iso.org\/standard\/62085.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ISO+9001%3A2015+Quality+management+systems+%E2%80%94+Requirements&rft.atitle=&rft.date=September+2015&rft.pub=International+Organization+for+Standardization&rft_id=https%3A%2F%2Fwww.iso.org%2Fstandard%2F62085.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Heras-42\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Heras_42-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Heras, I\u00f1aki; Dick, Gavin P.M.; Casades\u00fas, Mart\u00ed (2002). \"ISO 9000 registration's impact on sales and profitability: A longitudinal analysis of performance before and after accreditation\". <i>International Journal of Quality & Reliability Management<\/i> <b>19<\/b> (6): 774\u2013791. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1108%2F02656710210429618\" target=\"_blank\">10.1108\/02656710210429618<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=ISO+9000+registration%27s+impact+on+sales+and+profitability%3A+A+longitudinal+analysis+of+performance+before+and+after+accreditation&rft.jtitle=International+Journal+of+Quality+%26+Reliability+Management&rft.aulast=Heras&rft.aufirst=I%C3%B1aki&rft.au=Heras%2C%26%2332%3BI%C3%B1aki&rft.au=Dick%2C%26%2332%3BGavin+P.M.&rft.au=Casades%C3%BAs%2C%26%2332%3BMart%C3%AD&rft.date=2002&rft.volume=19&rft.issue=6&rft.pages=774%E2%80%93791&rft_id=info:doi\/10.1108%2F02656710210429618&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-43\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-43\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Abuhav, I. (2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=NmUlDgAAQBAJ&printsec=frontcover\" target=\"_blank\">\"Chapter 4 Context of the Organization\"<\/a>. <i>ISO 9001: 2015 - A Complete Guide to Quality Management Systems<\/i>. CRC Press. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9781498733212<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=NmUlDgAAQBAJ&printsec=frontcover\" target=\"_blank\">https:\/\/books.google.com\/books?id=NmUlDgAAQBAJ&printsec=frontcover<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+4+Context+of+the+Organization&rft.atitle=ISO+9001%3A+2015+-+A+Complete+Guide+to+Quality+Management+Systems&rft.aulast=Abuhav%2C+I.&rft.au=Abuhav%2C+I.&rft.date=2017&rft.pub=CRC+Press&rft.isbn=9781498733212&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DNmUlDgAAQBAJ%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ULAbout-44\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ULAbout_44-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ulstandards.ul.com\/about\/\" target=\"_blank\">\"About\"<\/a>. Underwriter Laboratories. 2023<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/ulstandards.ul.com\/about\/\" target=\"_blank\">https:\/\/ulstandards.ul.com\/about\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=About&rft.atitle=&rft.date=2023&rft.pub=Underwriter+Laboratories&rft_id=https%3A%2F%2Fulstandards.ul.com%2Fabout%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ULStandardsCat-45\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ULStandardsCat_45-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.shopulstandards.com\/Catalog.aspx\" target=\"_blank\">\"Standards & Publications\"<\/a>. Underwriter Laboratories. 2023<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.shopulstandards.com\/Catalog.aspx\" target=\"_blank\">https:\/\/www.shopulstandards.com\/Catalog.aspx<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Standards+%26+Publications&rft.atitle=&rft.date=2023&rft.pub=Underwriter+Laboratories&rft_id=https%3A%2F%2Fwww.shopulstandards.com%2FCatalog.aspx&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230516215324\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.411 seconds\nReal time usage: 0.435 seconds\nPreprocessor visited node count: 30829\/1000000\nPost\u2010expand include size: 231346\/2097152 bytes\nTemplate argument size: 70246\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 74244\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 381.589 1 -total\n 92.04% 351.218 1 Template:Reflist\n 73.63% 280.967 45 Template:Citation\/core\n 58.17% 221.972 38 Template:Cite_web\n 19.18% 73.189 5 Template:Cite_journal\n 13.26% 50.594 36 Template:Date\n 7.93% 30.277 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\n 4.56% 17.419 2 Template:Cite_book\n 3.84% 14.671 11 Template:Citation\/identifier\n 3.81% 14.530 52 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14176-0!canonical and timestamp 20230516215324 and revision id 51998. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","15a608383abc44912e4e0b246caa1a92_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/b2\/FDA_Food_Safety_%26_Applied_Nutrition_Lab_%283830%29_%287944692320%29.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/7\/79\/Mechanical_Testing_Lab_%285426178594%29.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/5\/5c\/A_technician_looks_at_samples_at_the_pharmaceutical_lab_in_Rockville%2C_Maryland_LCCN2011631564.tif\/lossy-page1-500px-A_technician_looks_at_samples_at_the_pharmaceutical_lab_in_Rockville%2C_Maryland_LCCN2011631564.tif.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/d\/d4\/COVID-19-related_research_%2849938485863%29.png"],"15a608383abc44912e4e0b246caa1a92_timestamp":1684275143,"ffc0963fbdac2cc3102de3a80c5a93a9_type":"article","ffc0963fbdac2cc3102de3a80c5a93a9_title":"1.3 Safety and quality in manufacturing industries","ffc0963fbdac2cc3102de3a80c5a93a9_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries","ffc0963fbdac2cc3102de3a80c5a93a9_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Introduction to manufacturing laboratories\/Safety and quality in manufacturing industriesFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n1.3 Safety and quality in manufacturing industries \nThe previous section highlighted a variety of laboratory testing activities that goes on across the three broad manufacturing-based roles, including safety and QC testing. Additionally, mention was made of standards and regulations affecting manufacturers and their QC methods (more on that in the second chapter). This focus on safety and quality in manufacturing certainly doesn't occur in a vacuum; after all, history has shown that today's focus on safety and quality are often byproducts of yesterday's people and animals injured or killed due to inadequate manufacturing processes, insufficient research, sheer incompetency, or willful neglect or malice.[1][2][3][4] However, the relationships among consumers, manufacturers, and regulators haven't always been easy. In his 1988 work Consumer Safety Regulation: Putting a Price on Life and Limb, Peter Asch had the following to say about these relationships[2]:\n\nThe anti-market position of most consumer safety advocates is necessarily severe. Consumers are believed to desire additional safety, and manufacturers to know how to produce it; yet the two groups, interacting in the marketplace, do not get the job done. Precisely why this failure occurs is seldom explained by advocates of expanded regulation.\r\n \r\nThis is not to claim that exponents of a larger government role are necessarily wrong, or that a compelling rationale for such public expansion cannot be invoked. Rather, the case has not usually been made. The success of consumer protection advocates is, therefore, all the more remarkable.\nTake the food and beverage industry, for instance. According to 2011 estimates by the CDC, \"48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year in the United States.\"[5] Whether contamination occurs in the natural growing environment of the produce farm or mechanical confines of a processed food manufacturer, these numbers point to a need for continuing to develop and modify policies and regulations that better prevent foodborne illness and encourage speedy response to such illnesses in the farm-to-fork process chain.[6]\nThe drivers for this safety and quality are most obvious when viewed from the governmental level. In the U.S., several government bodies play a roll in testing and monitoring food safety and quality. For example, the USDA estimated in 2017 that some \"7,500 food safety inspection personnel go to work in more than 6,000 regulated food facilities and 122 ports of entry,\" and \"[a]nother 2,000 food safety professionals go to work in three public health laboratories, 10 district offices, and our headquarters office. These employees run test results, dispatch outbreak investigators, and unpack data to reveal telling trends and inform proactive, prevention-based policies that will lead to safer food and fewer illnesses.\"[7] In another example, the CDC and its FoodNet surveillance program conducts \"active surveillance; surveys of laboratories, physicians, and the general population; and population-based epidemiologic studies\" for roughly 15 percent of the U.S. population.[8] Additionally, entities like the USDA and the FDA are significant forces behind the development of regulations that affect how and when other entities\u2014governmental and non-governmental\u2014conduct their food and beverage testing and production activities.\nIn the same way, other manufacturing industries' motivations and actions towards quality and safety are driven by standards and regulations (as well as a desire to remain competitive, relevant, and profitable). From pharmaceuticals and cosmetics to gasoline and paints, manufacturers who wish to maintain a level of success in their industry will put additional focus on the safety and quality of their products, and as we learned above, that task usually falls into the domain of the manufacturing lab, be it in the manufacturing plant proper or outside the organization. That said, safety and quality labs exist not just because of regulatory controls, but also because of private incentives towards maintaining reputation and a standard of quality in the industry. Talking specifically of food safety but applicable to other industrues, Virginia Tech's John Bovay emphasized this in an August 2022 research paper[9]:\n\nProducers and sellers often implement private or collective standards for food safety as an investment in their own reputations. Producers who have invested in such standards can benefit from additional regulations that improve safety because these regulations can further bolster the reputation of the industry and also raise costs for rival firms. Thus, food-safety regulations may have effects on competition and certainly can have differential welfare effects.\nThat is all to say that reputation, standards, and regulation are interlinked in producer efforts towards safer, higher-quality products. Supporting those efforts is, in turn, quality, standardized laboratory testing that meets or exceeds the needs of the producer, as well as the overall industry. Furthering those laboratory efforts of gauging the quality of manufactured products are information management systems, which unify analytical data, help better report it, and ensure the accuracy and timeliness of that reported data. However, before we can examine the information management and informatics solutions that assist manufacturing-related laboratories in their efforts, we first need to discuss the standards and regulations affecting manufacturers and the laboratories they depend on.\n\nReferences \n\n\n\u2191 Center for Policy Alternatives at the Massachusetts Institute of Technology (1980). Benefits of Environmental, Health, and Safety Regulation. U.S. Government Printing Office. pp. 100. https:\/\/books.google.com\/books?id=VadeKZOzcmwC&pg=PA1 .   \n \n\n\u2191 2.0 2.1 Asch, Peter (1988). Consumer safety regulation: putting a price on life and limb. New York: Oxford University Press. pp. 3\u201314. ISBN 978-0-19-504972-5. https:\/\/books.google.com\/books?id=Pi_nCwAAQBAJ&pg=PA1 .   \n \n\n\u2191 Dwyer, Tom (1991). Life and death at work: industrial accidents as a case of socially produced error. Plenum studies in work and industry. New York: Plenum Press. ISBN 978-0-306-43949-0.   \n \n\n\u2191 CoVan, James (1995). Safety engineering. New dimensions in engineering. New York: Wiley. ISBN 978-0-471-55612-1.   \n \n\n\u2191 \"Burden of Foodborne Illness: Overview\". Estimates of Foodborne Illness in the United States. Centers for Disease Control and Prevention. 5 November 2018. https:\/\/www.cdc.gov\/foodborneburden\/estimates-overview.html . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Burden of Foodborne Illness: Questions and Answers\". Estimates of Foodborne Illness in the United States. Centers for Disease Control and Prevention. 5 November 2018. https:\/\/www.cdc.gov\/foodborneburden\/estimates-overview.html . Retrieved 05 May 2023 .   \n \n\n\u2191 Almanza, A.V. (21 February 2017). \"The U.S. Food Safety System Has Come A Long Way in 50 Years\". U.S. Department of Agriculture. https:\/\/www.usda.gov\/media\/blog\/2016\/07\/05\/us-food-safety-system-has-come-long-way-50-years . Retrieved 05 May 2023 .   \n \n\n\u2191 \"About FoodNet\". Centers for Disease Control and Prevention. 23 September 2021. https:\/\/www.cdc.gov\/foodnet\/about.html . Retrieved 05 May 2023 .   \n \n\n\u2191 Bovay, John (18 August 2022). \"Food safety, reputation, and regulation\" (in en). Applied Economic Perspectives and Policy: aepp.13315. doi:10.1002\/aepp.13315. ISSN 2040-5790. https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/aepp.13315 .   \n \n\n\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 1. Introduction to manufacturing laboratories\nTitle: LIMS Selection Guide for Manufacturing Quality Control\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: May 2023\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 21:51.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 4 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","ffc0963fbdac2cc3102de3a80c5a93a9_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Introduction_to_manufacturing_laboratories_Safety_and_quality_in_manufacturing_industries rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Introduction_to_manufacturing_laboratories_Safety_and_quality_in_manufacturing_industries skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction to manufacturing laboratories\/Safety and quality in manufacturing industries<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"1.3_Safety_and_quality_in_manufacturing_industries\">1.3 Safety and quality in manufacturing industries<\/span><\/h3>\n<p>The previous section highlighted a variety of laboratory testing activities that goes on across the three broad manufacturing-based roles, including safety and QC testing. Additionally, mention was made of standards and regulations affecting manufacturers and their QC methods (more on that in the second chapter). This focus on safety and quality in manufacturing certainly doesn't occur in a vacuum; after all, history has shown that today's focus on safety and quality are often byproducts of yesterday's people and animals injured or killed due to inadequate manufacturing processes, insufficient research, sheer incompetency, or willful neglect or malice.<sup id=\"rdp-ebb-cite_ref-1\" class=\"reference\"><a href=\"#cite_note-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AschConsum88_2-0\" class=\"reference\"><a href=\"#cite_note-AschConsum88-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-3\" class=\"reference\"><a href=\"#cite_note-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-4\" class=\"reference\"><a href=\"#cite_note-4\">[4]<\/a><\/sup> However, the relationships among consumers, manufacturers, and regulators haven't always been easy. In his 1988 work <i>Consumer Safety Regulation: Putting a Price on Life and Limb<\/i>, Peter Asch had the following to say about these relationships<sup id=\"rdp-ebb-cite_ref-AschConsum88_2-1\" class=\"reference\"><a href=\"#cite_note-AschConsum88-2\">[2]<\/a><\/sup>:\n<\/p>\n<blockquote><p>The anti-market position of most consumer safety advocates is necessarily severe. Consumers are believed to desire additional safety, and manufacturers to know how to produce it; yet the two groups, interacting in the marketplace, do not get the job done. Precisely why this failure occurs is seldom explained by advocates of expanded regulation.<br \/> <br \/>This is not to claim that exponents of a larger government role are necessarily wrong, or that a compelling rationale for such public expansion cannot be invoked. Rather, the case has not usually been made. The success of consumer protection advocates is, therefore, all the more remarkable.<\/p><\/blockquote>\n<p>Take the food and beverage industry, for instance. According to 2011 estimates by the CDC, \"48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year in the United States.\"<sup id=\"rdp-ebb-cite_ref-CDCBurdenFood18_5-0\" class=\"reference\"><a href=\"#cite_note-CDCBurdenFood18-5\">[5]<\/a><\/sup> Whether contamination occurs in the natural growing environment of the produce farm or mechanical confines of a processed food manufacturer, these numbers point to a need for continuing to develop and modify policies and regulations that better prevent foodborne illness and encourage speedy response to such illnesses in the farm-to-fork process chain.<sup id=\"rdp-ebb-cite_ref-CDCBurdenQ.26A18_6-0\" class=\"reference\"><a href=\"#cite_note-CDCBurdenQ.26A18-6\">[6]<\/a><\/sup>\n<\/p><p>The drivers for this safety and quality are most obvious when viewed from the governmental level. In the U.S., several government bodies play a roll in testing and monitoring food safety and quality. For example, the USDA estimated in 2017 that some \"7,500 food safety inspection personnel go to work in more than 6,000 regulated food facilities and 122 ports of entry,\" and \"[a]nother 2,000 food safety professionals go to work in three public health laboratories, 10 district offices, and our headquarters office. These employees run test results, dispatch outbreak investigators, and unpack data to reveal telling trends and inform proactive, prevention-based policies that will lead to safer food and fewer illnesses.\"<sup id=\"rdp-ebb-cite_ref-AlmanzaTheUSFood17_7-0\" class=\"reference\"><a href=\"#cite_note-AlmanzaTheUSFood17-7\">[7]<\/a><\/sup> In another example, the CDC and its FoodNet surveillance program conducts \"active surveillance; surveys of laboratories, physicians, and the general population; and population-based epidemiologic studies\" for roughly 15 percent of the U.S. population.<sup id=\"rdp-ebb-cite_ref-CDCAboutFN21_8-0\" class=\"reference\"><a href=\"#cite_note-CDCAboutFN21-8\">[8]<\/a><\/sup> Additionally, entities like the USDA and the FDA are significant forces behind the development of regulations that affect how and when other entities\u2014governmental and non-governmental\u2014conduct their food and beverage testing and production activities.\n<\/p><p>In the same way, other manufacturing industries' motivations and actions towards quality and safety are driven by standards and regulations (as well as a desire to remain competitive, relevant, and profitable). From pharmaceuticals and cosmetics to gasoline and paints, manufacturers who wish to maintain a level of success in their industry will put additional focus on the safety and quality of their products, and as we learned above, that task usually falls into the domain of the manufacturing lab, be it in the manufacturing plant proper or outside the organization. That said, safety and quality labs exist not just because of regulatory controls, but also because of private incentives towards maintaining reputation and a standard of quality in the industry. Talking specifically of food safety but applicable to other industrues, Virginia Tech's John Bovay emphasized this in an August 2022 research paper<sup id=\"rdp-ebb-cite_ref-9\" class=\"reference\"><a href=\"#cite_note-9\">[9]<\/a><\/sup>:\n<\/p>\n<blockquote><p>Producers and sellers often implement private or collective standards for food safety as an investment in their own reputations. Producers who have invested in such standards can benefit from additional regulations that improve safety because these regulations can further bolster the reputation of the industry and also raise costs for rival firms. Thus, food-safety regulations may have effects on competition and certainly can have differential welfare effects.<\/p><\/blockquote>\n<p>That is all to say that reputation, standards, and regulation are interlinked in producer efforts towards safer, higher-quality products. Supporting those efforts is, in turn, quality, standardized laboratory testing that meets or exceeds the needs of the producer, as well as the overall industry. Furthering those laboratory efforts of gauging the quality of manufactured products are <a href=\"https:\/\/www.limswiki.org\/index.php\/Information_management\" title=\"Information management\" class=\"wiki-link\" data-key=\"f8672d270c0750a858ed940158ca0a73\">information management<\/a> systems, which unify analytical data, help better report it, and ensure the accuracy and timeliness of that reported data. However, before we can examine the information management and <a href=\"https:\/\/www.limswiki.org\/index.php\/Informatics_(academic_field)\" title=\"Informatics (academic field)\" class=\"wiki-link\" data-key=\"0391318826a5d9f9a1a1bcc88394739f\">informatics<\/a> solutions that assist manufacturing-related laboratories in their efforts, we first need to discuss the standards and regulations affecting manufacturers and the laboratories they depend on.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-1\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Center for Policy Alternatives at the Massachusetts Institute of Technology (1980). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=VadeKZOzcmwC&pg=PA1\" target=\"_blank\"><i>Benefits of Environmental, Health, and Safety Regulation<\/i><\/a>. U.S. Government Printing Office. pp. 100<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=VadeKZOzcmwC&pg=PA1\" target=\"_blank\">https:\/\/books.google.com\/books?id=VadeKZOzcmwC&pg=PA1<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Benefits+of+Environmental%2C+Health%2C+and+Safety+Regulation&rft.aulast=Center+for+Policy+Alternatives+at+the+Massachusetts+Institute+of+Technology&rft.au=Center+for+Policy+Alternatives+at+the+Massachusetts+Institute+of+Technology&rft.date=1980&rft.pages=pp.%26nbsp%3B100&rft.pub=U.S.+Government+Printing+Office&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DVadeKZOzcmwC%26pg%3DPA1&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AschConsum88-2\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-AschConsum88_2-0\">2.0<\/a><\/sup> <sup><a href=\"#cite_ref-AschConsum88_2-1\">2.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Asch, Peter (1988). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=Pi_nCwAAQBAJ&pg=PA1\" target=\"_blank\"><i>Consumer safety regulation: putting a price on life and limb<\/i><\/a>. New York: Oxford University Press. pp. 3\u201314. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-19-504972-5<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=Pi_nCwAAQBAJ&pg=PA1\" target=\"_blank\">https:\/\/books.google.com\/books?id=Pi_nCwAAQBAJ&pg=PA1<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Consumer+safety+regulation%3A+putting+a+price+on+life+and+limb&rft.aulast=Asch&rft.aufirst=Peter&rft.au=Asch%2C%26%2332%3BPeter&rft.date=1988&rft.pages=pp.%26nbsp%3B3%E2%80%9314&rft.place=New+York&rft.pub=Oxford+University+Press&rft.isbn=978-0-19-504972-5&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DPi_nCwAAQBAJ%26pg%3DPA1&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-3\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Dwyer, Tom (1991). <i>Life and death at work: industrial accidents as a case of socially produced error<\/i>. Plenum studies in work and industry. New York: Plenum Press. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-306-43949-0.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Life+and+death+at+work%3A+industrial+accidents+as+a+case+of+socially+produced+error&rft.aulast=Dwyer&rft.aufirst=Tom&rft.au=Dwyer%2C%26%2332%3BTom&rft.date=1991&rft.series=Plenum+studies+in+work+and+industry&rft.place=New+York&rft.pub=Plenum+Press&rft.isbn=978-0-306-43949-0&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-4\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">CoVan, James (1995). <i>Safety engineering<\/i>. New dimensions in engineering. New York: Wiley. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-471-55612-1.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Safety+engineering&rft.aulast=CoVan&rft.aufirst=James&rft.au=CoVan%2C%26%2332%3BJames&rft.date=1995&rft.series=New+dimensions+in+engineering&rft.place=New+York&rft.pub=Wiley&rft.isbn=978-0-471-55612-1&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCBurdenFood18-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCBurdenFood18_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/foodborneburden\/estimates-overview.html\" target=\"_blank\">\"Burden of Foodborne Illness: Overview\"<\/a>. <i>Estimates of Foodborne Illness in the United States<\/i>. Centers for Disease Control and Prevention. 5 November 2018<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/foodborneburden\/estimates-overview.html\" target=\"_blank\">https:\/\/www.cdc.gov\/foodborneburden\/estimates-overview.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Burden+of+Foodborne+Illness%3A+Overview&rft.atitle=Estimates+of+Foodborne+Illness+in+the+United+States&rft.date=5+November+2018&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Ffoodborneburden%2Festimates-overview.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCBurdenQ.26A18-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCBurdenQ.26A18_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/foodborneburden\/estimates-overview.html\" target=\"_blank\">\"Burden of Foodborne Illness: Questions and Answers\"<\/a>. <i>Estimates of Foodborne Illness in the United States<\/i>. Centers for Disease Control and Prevention. 5 November 2018<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/foodborneburden\/estimates-overview.html\" target=\"_blank\">https:\/\/www.cdc.gov\/foodborneburden\/estimates-overview.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Burden+of+Foodborne+Illness%3A+Questions+and+Answers&rft.atitle=Estimates+of+Foodborne+Illness+in+the+United+States&rft.date=5+November+2018&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Ffoodborneburden%2Festimates-overview.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AlmanzaTheUSFood17-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AlmanzaTheUSFood17_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Almanza, A.V. (21 February 2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.usda.gov\/media\/blog\/2016\/07\/05\/us-food-safety-system-has-come-long-way-50-years\" target=\"_blank\">\"The U.S. Food Safety System Has Come A Long Way in 50 Years\"<\/a>. U.S. Department of Agriculture<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.usda.gov\/media\/blog\/2016\/07\/05\/us-food-safety-system-has-come-long-way-50-years\" target=\"_blank\">https:\/\/www.usda.gov\/media\/blog\/2016\/07\/05\/us-food-safety-system-has-come-long-way-50-years<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+U.S.+Food+Safety+System+Has+Come+A+Long+Way+in+50+Years&rft.atitle=&rft.aulast=Almanza%2C+A.V.&rft.au=Almanza%2C+A.V.&rft.date=21+February+2017&rft.pub=U.S.+Department+of+Agriculture&rft_id=https%3A%2F%2Fwww.usda.gov%2Fmedia%2Fblog%2F2016%2F07%2F05%2Fus-food-safety-system-has-come-long-way-50-years&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCAboutFN21-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCAboutFN21_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/foodnet\/about.html\" target=\"_blank\">\"About FoodNet\"<\/a>. Centers for Disease Control and Prevention. 23 September 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/foodnet\/about.html\" target=\"_blank\">https:\/\/www.cdc.gov\/foodnet\/about.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=About+FoodNet&rft.atitle=&rft.date=23+September+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Ffoodnet%2Fabout.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-9\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Bovay, John (18 August 2022). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/aepp.13315\" target=\"_blank\">\"Food safety, reputation, and regulation\"<\/a> (in en). <i>Applied Economic Perspectives and Policy<\/i>: aepp.13315. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1002%2Faepp.13315\" target=\"_blank\">10.1002\/aepp.13315<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" data-key=\"a5dec3e4d005e654c29ad167ab53f53a\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/issn\/2040-5790\" target=\"_blank\">2040-5790<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/aepp.13315\" target=\"_blank\">https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/aepp.13315<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Food+safety%2C+reputation%2C+and+regulation&rft.jtitle=Applied+Economic+Perspectives+and+Policy&rft.aulast=Bovay&rft.aufirst=John&rft.au=Bovay%2C%26%2332%3BJohn&rft.date=18+August+2022&rft.pages=aepp.13315&rft_id=info:doi\/10.1002%2Faepp.13315&rft.issn=2040-5790&rft_id=https%3A%2F%2Fonlinelibrary.wiley.com%2Fdoi%2F10.1002%2Faepp.13315&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<p><br \/>\n<\/p>\n<div align=\"center\">-----Go to of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: 1. Introduction to manufacturing laboratories\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for Manufacturing Quality Control<\/i>\n<\/p><p><b>Edition<\/b>: First Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: May 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230516215335\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.121 seconds\nReal time usage: 0.140 seconds\nPreprocessor visited node count: 6613\/1000000\nPost\u2010expand include size: 50573\/2097152 bytes\nTemplate argument size: 14387\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 14796\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 128.530 1 -total\n 92.26% 118.579 1 Template:Reflist\n 64.72% 83.184 9 Template:Citation\/core\n 44.30% 56.944 4 Template:Cite_book\n 24.61% 31.632 4 Template:Cite_web\n 13.32% 17.126 8 Template:Date\n 10.97% 14.104 1 Template:Cite_journal\n 9.84% 12.643 5 Template:Citation\/identifier\n 7.64% 9.824 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries\n 4.50% 5.790 11 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14174-0!canonical and timestamp 20230516215335 and revision id 51995. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","ffc0963fbdac2cc3102de3a80c5a93a9_images":[],"ffc0963fbdac2cc3102de3a80c5a93a9_timestamp":1684275142,"f5c58bc41bd3b4f5fc4356c7aea9ef5c_type":"article","f5c58bc41bd3b4f5fc4356c7aea9ef5c_title":"1.2 Laboratory roles and activities in the industry","f5c58bc41bd3b4f5fc4356c7aea9ef5c_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry","f5c58bc41bd3b4f5fc4356c7aea9ef5c_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Introduction to manufacturing laboratories\/Laboratory roles and activities in the industryFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 1.2 Laboratory roles and activities in the industry \n\n1.1 1.2.1 R&D roles and activities \n1.2 1.2.2 Pre-manufacturing and manufacturing roles and activities \n1.3 1.2.3 Post-production regulation and security roles and activities \n1.4 1.2.4 Tangential laboratory work \n\n\n2 References \n\n\n\n1.2 Laboratory roles and activities in the industry \nToday, the \"manufacturing laboratory\" is a complex entity that goes beyond the general idea of a lab making or researching things. Many of the historical aspects discussed prior still hold today, but other aspects have changed. As indicated in the introduction, the world of manufacturing encompasses a wide swath of industries and sub-industries, each with their own nuances. Given the nuances of pharmaceutical manufacturing, food and beverage development, petrochemical extraction and use, and other industries, it's difficult to make broad statements about manufacturing laboratories in general. However, the rest of this guide will attempt to do just that, while at times pointing out a few of those nuances found in specific industries.\nThe biggest area of commonality is found, unsurprisingly, in the roles manufacturing-based labs play today, as well as the types of lab activities they're conducting within those roles. These roles prove to be important in the greater scheme of industry activities, in turn providing a number of benefits to society. As gleaned from prior discussion, as well as other sources, these laboratory roles can be broadly broken into three categories: research and development (R&D), pre-manufacturing and manufacturing, and post-production regulation and security. Additionally, each of these categories has its own types of laboratory activities. \nThe scientific disciplines that go into these laboratory roles and activities is as diverse as the manufacturing industries and sub-industries that make up the manufacturing world. For example, the \nfood and beverage laboratory taps into disciplines such as biochemistry, biotechnology, chemical engineering, chemistry, fermentation science, materials science, microbiology, molecular gastronomy, and nutrition.[1][2][3][4] However, the paper and printing industry taps into disciplines such as biochemistry, biology, chemistry, environmental science, engineering, forestry, and physics.[5][6] By extension, the reader can imagine that these and other industries also have a wide variety of laboratory techniques associated with their R&D, manufacturing, and post-production activities.\nThe following subsections more closely examine the three roles manufacturing-based labs can play, as well as a few examples of lab-related activities found within those roles.\n\n 1.2.1 R&D roles and activities \nThe National Institute of Standards and Technology (NIST) and its Technology Partnerships Office offer a detailed definition of manufacturing-related R&D as an activity \"aimed at increasing the competitive capability of manufacturing concerns,\" and that \"encompasses improvements in existing methods or processes, or wholly new processes, machines or system.\"[7] They break this down into four different technology levels[7]:\nUnit process-level technologies that create or improve manufacturing processes,\nMachine-level technologies that create or improve manufacturing equipment,\nSystems-level technologies for innovation in the manufacturing enterprise, and\nEnvironment- or societal-level technologies that improve workforce abilities and manufacturing competitiveness.\nObviously, this definition applies to actual development of and innovation towards methods of improving and streamlining manufacturing processes. However, this same concept can, in part, can be applied to the actual products made in a manufacturing plant. Not only does product-based R&D focus on improving \"existing methods and processes,\" but it also focuses on \"manufacturing competitiveness\" by developing new and innovating existing products that meet end users' needs. Manufacturing-based R&D laboratories play an important role in this regard.\nThe laboratory participating in this role is performing one or more tasks that relate to the development or improvement of a manufactured good. This often leads to a commercial formulation, process, or promising insight into a product. The R&D lab may appear outside the manufacturing facility proper, but not necessarily always. Some manufacturing companies may have an entire research complex dedicated to creating and improving some aspect of their products.[8] Other companies may take their R&D to a third-party consulting lab dedicated to conducting development and formulation activities for manufacturers.[9][10] Industrial research activities aren't confined to manufacturers, however. Some higher education institutions provide laboratory-based research and development opportunities to students engaging in work-study programs, often in partnership with some other commercial enterprise.[11] \nThe following types of lab-related activities may be associated with the R&D role:\nOverall product development and innovation: Jain et al. note in their book on managing R&D activities that in 2010, 60 percent of U.S. R&D was focused on product development, while 22 percent focused on applied research and 18 percent on basic research. However, they also argue that any R&D lab worth its weight should have a mix of these activities, while also including customer participation in the needs assessment and innovation activities that take place in product development and other research activities. Jain et al. define a manufacturer's innovation activities as \"combining understanding and invention in the form of socially useful and affordable products and processes.\"[12] As the definition denotes, newly developed products (\"offerings\") and processes (usually which improve some level of efficiency and effectiveness) come out of innovation activities. Additionally, platforms that turn existing components or building blocks into a new derivative offering (e.g., a new model or \"generation\" of product), as well as \"solutions that solve end-to-end customer problems,\" can be derived from innovation. Those activities can focus on more risky radical innovation to a new product or take a more cautious incremental approach to improvements on existing products.[13] \nReformulation: Reformulation involves the material substitution of one or more raw materials used in the production of a product to accomplish some stated goal. That goal may be anything from reducing the toxicity or volume of wastes generated[14][15][16] and improving the overall healthiness of the product[17][18], to transitioning from traditional holistic medicine approaches to more modern biomedical approaches.[19] Examples of products that have seen reformulation by manufacturers include: \n\nPaints and other coatings[14],\nFuels such as gasoline[16],\nFoods and beverages[17][18], and\nPharmaceuticals and cosmetics.[15][19]\nIn the end, reformulation is a means for improving impacts on the end user, the environment, or even the long-term budget of the manufacturer. The type of lab activities associated with reformulation largely varies by product; the laboratory methods used to reformulate gasoline may be quite different from those in a food and beverage lab. Reformulation can also be a complicated process, as found with pharmaceutical products. The reformulated product \"must have the same therapeutic effect, stability, and purity profile\" as the original, while maintaining pleasing aesthetic qualities to the end user. Adding to the problem is regulatory approval times of such pharmaceutical reformulations.[15]\nNondestructive testing and materials characterization: Raj et al. describe nondestructive testing (NDT) as \"techniques that are based on the application of physical principles employed for the purpose of determining the characteristics of materials or components or systems and for detecting and assessing the inhomogeneities and harmful defects without impairing the usefulness of such materials or components or systems.\"[20] NDT has many applications, including with food, steel, petroleum, medical devices, transportation, and utilities manufacturing, as well as electronics manufacturing.[21][22][23] It also plays an important role in materials testing and characterization.[24] NDT and materials testing is often used as a quality control mechanism during manufacturing (see the next subsection), but it can also be used during the initial R&D process to determine if a prototype is functioning as intended or a material is satisfactory for a given application.[20] \nStability, cycle, and challenge testing: Multiple deteriorative catalysts can influence the shelf life of a manufactured product, from microbiological contaminants and chemical deterioration to storage conditions and the packaging itself. As such, there are multiple approaches to taming the effects of those catalysts, from introducing additives to improving the packaging.[25] However, stability, cycle, and challenge testing must be conducted on many products to determine what deleterious factors are in play. The analytical techniques applied in stability, cycle, and challenge testing will vary based on, to a large degree, the product matrix and its chemical composition.[25] Microbiological testing is sure to be involved, particularly in challenge testing, which simulates what could happen to a product if contaminated by a microorganism and placed in a representative storage condition.[26][27] Calorimetry, spectrophotometry, spectroscopy, and hyperspectral imaging may be used to properly assess color, particularly when gauging food quality.[25] Other test types that may be used include water content, texture, viscosity, dispersibility, glass transition, and gas chromatography.[25] In the end, the substrate being examined will be a major determiner of what kind of lab methods are used. The lab method chosen for stability, cycle, and challenge testing should optimally be one that errs on the side of caution and is appropriate to the test, even if it takes longer. As Chen notes: \"A longer test cycle is less a concern for stability protocol as the study typically has a limited number of samples. Applying a less reliable method to the limited number of samples in a stability study can be problematic.\"[27]\nPackaging analysis and extractable and leachable testing: Materials that contact pharmaceuticals, foods and beverages, cosmetics, and more receive special regulatory consideration in various parts of the world. This includes alloys, bioplastics, can coatings, glass, metals, regenerated cellulose materials, paper, paperboard, plastics, printing inks, rubber, textiles, waxes, and woods.[28] As such, meeting regulatory requirements and making inroads with packaging development can be a complicated process. Concerns of chemicals and elements that can be extracted or leach into sensitive products add another layer of complexity to developing and choosing packaging materials for many manufactured goods. This requires extractable and leachable testing at various phases of product development to ensure the packaging selected during formulation is safe and effective.[27][29] Extractable and leachable testing for packaging could involve a number of techniques ranging from gas and liquid chromatography to ion chromatography and inductively coupled plasma mass spectrometry.[30]\n\n1.2.2 Pre-manufacturing and manufacturing roles and activities \nThe laboratory participating in these roles is performing one or more tasks that relate to the preparative (i.e., pre-manufacturing) or quality control (QC; i.e., manufacturing) activities of production. An example of preparative work is conducting allergen, calorie, and nutrition testing for a formulated food and beverage product. Calorie and nutrition testing\u2014conducted in part as a means of meeting regulation-driven labeling requirements\u2014lands firmly in the role of pre-manufacturing activity, most certainly after commercial formulation and packing requirements have been finalized but before the formal manufacturing process has begun.[31] Allergen testing works in a similar fashion, though the manufacturer ideally uses a full set of best practices for food allergen management and testing, from confirming allergens (and correct labeling) from ingredients ordered to performing final production line cleanup (e.g., when a new allergen-free commercial formulation is being made or an unintended contamination has occurred).[32] These types of pre-production analyses aren't uncommon to other types of manufacturing, discussed below.\nAs for in-process manufacturing QC, some QC and quality assurance (QA) methods may already be built into the manufacturing process in-line, not requiring a lab. For example, poka-yoke mechanisms that inhibit, correct, or highlight errors as they occur, as close to the source as possible\u2014may be built in-line to a manufacturing process to prevent a process from continuing should a detectable error occur, or until a certain condition has been reached.[33][34] However, despite the value of inline QC\/QA, these activities also happen beyond the production line, in the laboratory (discussed further, below). \nThe following types of lab-related activities may be associated with the pre-manufacturing and manufacturing role:\nVarious pre-manufacturing analyses: Also known as pre-production, some level of laboratory activity takes place here. Like the previously mentioned food and beverage industry, the garment manufacturing industry, for example, will have its own laboratory-based pre-production activities, including testing various raw material samples for potential use and quality testing pre-production samples before deciding to go into full production.[35] In another example, a manufacturer intending to produce \"a new chemical substance for a non-exempt commercial purpose\" in the U.S. must submit a pre-manufacture notice to the Environmental Protection Agency (EPA), which must include \"test data on the effect to human health or the environment.\"[36] Given this regulatory requirement, some final pre-approval testing much occur to ensure the chemical meets regulatory requirements before full manufacturing processes begin.\nQuality control testing: While QC testing can appear in multiple manufacturing laboratory roles, it's most noticeable in the pre-manufacturing and manufacturing role. Manufacturers in many industries have set up formal testing laboratories to better ensure that their products conform to a determined set of accepted standards, whether those standards come from a standards-setting organization or are internally derived. QC testing is a multi-pronged approach that includes both non-laboratory and laboratory analyses, whether it is in real-time or periodically during manufacturing activities. The previously mentioned inline poka-yoke mechanisms provide an example of non-laboratory QC activities. However, when rigorous mechanical, chemical, or some other form of testing of a manufactured product is required at different stages of production, a laboratory will be involved. This type of in-process inspection occurs after roughly 10 to 30 percent of products are completed.[37] Manufacturers can take multiple approaches to QC testing, depending on the circumstances of manufacturing. This includes 100 percent inspection methods, Six Sigma approaches, X-bar charting, total quality management, statistical quality control, Taguchi approaches, and more.[38] \nThe actual types of analyses going on during QC will entirely depend on the material being tested, the functionality of the item, and the intended goal of testing. For example, polymerase chain reaction (PCR) testing of infant formula for the pathogenic bacterium Cronobacter sakazakii[39] during production runs is entirely different from periodic Rockwell, Brinell, or Vickers hardness testing of aerospace fasteners.[40] NDT and materials testing, discussed in the prior subsection about R&D, can also occur during the various phases of manufacturing, as part of an overall quality control effort.[20] \n\n1.2.3 Post-production regulation and security roles and activities \nThe laboratory participating in these roles is performing one or more tasks that relate to the post-production examination of products for regulatory, security, or accreditation purposes. Labs are often third parties accrediting a producer to a set of standards, ensuring regulatory compliance, conducting authenticity and adulteration testing, conducting security checks at borders, and applying contamination testing as part of an overall effort to track down contamination sources. In addition to ensuring a safer product, society also benefits from these and similar labs by better holding producers legally accountable for their production methods and obligations.\nThe following types of lab-related activities may be associated with the post-production regulation and security role:\nAuthenticity and adulteration testing: This type of testing is largely conducted to ensure products ingested, injected, inserted, and\/or handled by humans and animals are safe to use and authentic to consumer expectations. Anything from food and pharmaceuticals to children's toys and fishing sinkers may be tested to ensure they contain what the manufacturer claims is contained in them. Foods and beverages, for example, are subject to a variety of food supply chain laws and regulations across national and international borders. As such, scientists have developed a number of analytical techniques \"to identify foods or food ingredients that are in breach of labeling requirement and may consequently be adulterated.\" Among these techniques are DNA fingerprinting; visible, ultraviolet, infrared, fluorescence emission, and nuclear magnetic resonance spectroscopy; mass spectrometry; isotopic analysis; chromatography; polymerase chain reaction; differential scanning calorimetry; chemometric; and \"electric nose and tongue\" techniques.[41][42] In the United States, certain toys are subject to being tested and certified to the ASTM F963-17 standard by the U.S. Consumer Product Safety Commission (CPSC), with some toys being tested for heavy metals in surface coatings, nitrosamines in rubber, and contaminates in pastes, putties, and gels.[43] Authenticity and adulteration testing may occur during post-production as part of meeting a manufacturer's regulatory requirements, or it may be conducted at a state or national border as part of a set of international trade rules. In most cases, the testing will be done by a third party laboratory or a regulatory body.\nAccreditation-led testing: In some cases, governments and other regulatory bodies provide a higher standard for a manufacturing-related laboratory process, which requires accreditation to that standard. For example, labs optionally accredited to Laboratory Accreditation for Analyses of Foods (LAAF) rules are recognized by the FDA as meeting the process requirements of the LAAF program for testing of specific sprouts, eggs, water, and certain foods being considered for import into the country.[44] LAAF represents one of several legal and regulatory forces driving accreditation of manufacturing-related laboratories to a higher standard. It also means greater potential for more testing opportunities for the third-party lab wishing to expand into enforcement and security roles. Similarly, the previously mentioned CPSC accredits labs to perform the specific testing required by children's product safety rules.[45] Again, as with authenticity and adulteration testing, accreditation-led testing is typically conducted by third-party labs separate from the manufacturer; however, this type of testing is a step above non-accredited labs and their methods, which may be required by certain manufacturers.\n\n1.2.4 Tangential laboratory work \nThe following tangential laboratory roles aren't necessarily found directly in the manufacturing center. However, some level of laboratory work is required in these roles, which intersect with the manufacturing industry in some capacity.\nProcessing equipment design, monitoring, and sanitation: \"Sanitation provides the hygienic conditions required to produce safe food,\" say Ho and Sandoval in chapter seven of Food Safety Engineering.[46] \"Improper sanitation of equipment can potentially introduce hazardous contamination to food and enhance pathogen harborage in the food-processing environment.\"[46] They note the value of sanitation standard operating procedures (SSOPs) to the production facility, which dictate sanitation methods and frequencies, monitoring methods, and record keeping methods.[46] These SSOPs are not only driven by good manufacturing practice (GMP) but also appropriate and effective laboratory testing. \nWhile Ho and Sandoval focus on food and beverage production, the proper design, monitoring and sanitation of manufacturing equipment extends beyond that industry, into areas such as pharmaceutical production and medical device manufacturing. That foundation of laboratory testing has occurred historically with the both the experience of regulated manufacturers and those scientists engineering and standardizing hygienic solutions for manufacturing industries. Combined, these industry and laboratory experiences have driven regulations and standards on hygienic design throughout the world. Broadly speaking, this has culminated in a set of manufacturing requirements, addressing physical and chemical properties such as being nontoxic, corrosion-resistant, and non-absorbent, to mechanical properties such as being durable and smooth, and operational properties such as being cleanable and low-maintenance.[47][48] In turn, these properties require laboratory and engineering knowledge about metals, alloys, plastics, and many other materials.[48] Here we find multi-disciplinary knowledge in materials science, microbiology, chemistry, physics, and more, implying a corresponding necessity for knowledge on a wide variety of testing methods.\nCalibration: Just as laboratories require their precision equipment be regularly calibrated to specific tolerances, manufacturers too require their equipment to be calibrated. Multiple types of equipment along the production line require the utmost in accuracy and consistency in order to create a finished product that is safe and fully functional. Manufacturers who fall behind on their calibration obligations are more prone to higher rates of rejected components and products, more cost overruns, more missed deadlines, and greater reputation damage.[49] As such, manufacturers increasingly depend on industrial maintenance providers, OEM providers, and laboratories to ensure their instruments and equipment meet operational tolerances.\n\nReferences \n\n\n\u2191 Nollet, L.M.L.; Toldr\u00e1, F., ed. (2015). Handbook of Food Analysis (Two Volume Set) (3rd ed.). CRC Press. pp. 1568. ISBN 9781482297843. https:\/\/books.google.com\/books?id=KtAdCgAAQBAJ&printsec=frontcover .   \n \n\n\u2191 Nielsen, S. (2015). Food Analysis Laboratory Manual (2nd ed.). Springer. pp. 177. ISBN 9781441914620. https:\/\/books.google.com\/books?id=i5TdyXBiwRsC&printsec=frontcover .   \n \n\n\u2191 Douglas, S.E. (July 2022). \"Labs by industry: Part 2\". The Laboratories of Our Lives: Labs, Labs Everywhere! (2nd ed.). LIMSwiki. https:\/\/www.limswiki.org\/index.php\/LII:The_Laboratories_of_Our_Lives:_Labs,_Labs_Everywhere!\/Labs_by_industry:_Part_2 . Retrieved 05 May 2023 .   \n \n\n\u2191 Bhandari, B.; Roos, Y.H. (2012). \"Chapter 1: Food Materials Science and Engineering: An Overview\". In Bhandari, Bhesh; Roos, Yrj\u00f6 H.. Food Materials Science and Engineering. Chichester, West Sussex, UK ; Ames, Iowa: Wiley-Blackwell. pp. 1\u201325. ISBN 978-1-4051-9922-3.   \n \n\n\u2191 Bajpai, P. (2010). \"Chapter 2: Overview of Pulp and Papermaking Processes\". Environmentally Friendly Production of Pulp and Paper. John Wiley & Sons. pp. 8\u201345. ISBN 9780470528105. https:\/\/books.google.com\/books?id=zjEeUpwepFMC&printsec=frontcover . Retrieved 05 May 2023 .   \n \n\n\u2191 Nyk\u00e4nen, Panu (2018), S\u00e4rkk\u00e4, Timo; Guti\u00e9rrez-Poch, Miquel; Kuhlberg, Mark, eds., \"Research and Development in the Finnish Wood Processing and Paper Industry, c. 1850\u20131990\", Technological Transformation in the Global Pulp and Paper Industry 1800\u20132018 (Cham: Springer International Publishing) 23: 35\u201364, doi:10.1007\/978-3-319-94962-8_3, ISBN 978-3-319-94961-1, http:\/\/link.springer.com\/10.1007\/978-3-319-94962-8_3 . Retrieved 2023-04-13   \n \n\n\u2191 7.0 7.1 Technology Partnerships Office (31 July 2019). \"Definition of Manufacturing-related R&D\". National Institute of Standards and Technology. https:\/\/www.nist.gov\/tpo\/definition-manufacturing-related-rd . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Mondelez International Breaks Ground for New Research & Development Center in Poland\". Mondelez International. 8 June 2016. https:\/\/ir.mondelezinternational.com\/news-releases\/news-release-details\/mondelez-international-breaks-ground-new-research-development . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Why You Need A Commercial Formula\". BevSource. 13 August 2022. https:\/\/www.bevsource.com\/news\/why-you-need-commercial-formula . Retrieved 05 May 2023 .   \n \n\n\u2191 Gude, T. (2019). \"Solutions Commonly Applied in Industry and Outsourced to Expert Laboratories\". In Suman, M.. Food Contact Materials Analysis: Mass Spectrometry Techniques. Royal Society of Chemistry. doi:10.1039\/9781788012973-00245. ISBN 9781788017190.   \n \n\n\u2191 \"Hartwick College Center for Craft Food & Beverage\". Hartwick College. https:\/\/www.hartwick.edu\/about-us\/center-for-craft-food-and-beverage\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Jain, Ravi; Triandis, Harry Charalambos; Weick, Cynthia Wagner (2010). \"Chapter 1: R&D Organizations and Research Categories\". Managing research, development and innovation: Managing the unmanageable (3rd ed.). Hoboken, N.J: Wiley. pp. 8. ISBN 978-0-470-40412-6. https:\/\/books.google.com\/books?id=nSgebaFKwvMC&pg=PA8 .   \n \n\n\u2191 Jain, Ravi; Triandis, Harry Charalambos; Weick, Cynthia Wagner (2010). \"Chapter 12: Models for Implementing Incremental and Radical Innovation\". Managing research, development and innovation: Managing the unmanageable (3rd ed.). Hoboken, N.J: Wiley. pp. 240\u2013241. ISBN 978-0-470-40412-6. https:\/\/books.google.com\/books?id=nSgebaFKwvMC&pg=PA240 .   \n \n\n\u2191 14.0 14.1 Dupont, R. Ryan; Ganesan, Kumar; Theodore, Louis (2017). Pollution prevention: sustainability, industrial ecology, and green engineering (Second edition ed.). Boca Raton: CRC Press, Taylor & Francis Group, CRC Press is an imprint of the Taylor & Francis Group, an informa business. pp. 382. ISBN 978-1-4987-4954-1. https:\/\/books.google.com\/books?id=3m4NDgAAQBAJ&pg=PA382 .   \n \n\n\u2191 15.0 15.1 15.2 Wang, Lawrence K.; Wang, Mu-Hao Sung; Hung, Yung-Tse, eds. (2022) (in en). Waste Treatment in the Biotechnology, Agricultural and Food Industries: Volume 1. Handbook of Environmental Engineering. 26. Cham: Springer International Publishing. pp. 108\u20139. doi:10.1007\/978-3-031-03591-3. ISBN 978-3-031-03589-0. https:\/\/books.google.com\/books?id=JxaIEAAAQBAJ&pg=PA108 .   \n \n\n\u2191 16.0 16.1 Committee on Environment and Public Works (28 September 2000). \"Federal Formulated Fuels Act of 2000: Report of the Committee on Environment and Public Works, United States Senate\". U.S. Government Printing Office. https:\/\/books.google.com\/books?id=dk-gi6ZZ_KsC&pg=PA1 . Retrieved 05 May 2023 .   \n \n\n\u2191 17.0 17.1 World Health Organization (2022) (in en). Reformulation of food and beverage products for healthier diets: policy brief. Geneva: World Health Organization. ISBN 978-92-4-003991-9. https:\/\/apps.who.int\/iris\/handle\/10665\/355755 .   \n \n\n\u2191 18.0 18.1 Raikos, Vassilios; Ranawana, Viren, eds. (2019) (in en). Reformulation as a Strategy for Developing Healthier Food Products: Challenges, Recent Developments and Future Prospects. Cham: Springer International Publishing. doi:10.1007\/978-3-030-23621-2. ISBN 978-3-030-23620-5. https:\/\/books.google.com\/books?id=zkG1DwAAQBAJ&pg=PA1 .   \n \n\n\u2191 19.0 19.1 Lechevalier, S\u00e9bastien, ed. (2019) (in en). Innovation Beyond Technology: Science for Society and Interdisciplinary Approaches. Creative Economy. Singapore: Springer Singapore. pp. 133\u20137. doi:10.1007\/978-981-13-9053-1. ISBN 978-981-13-9052-4. https:\/\/books.google.com\/books?id=Sx2nDwAAQBAJ&pg=PA133 .   \n \n\n\u2191 20.0 20.1 20.2 Raj, B.; Jayakumar, T.; Thavasimuthu, M. (2014). Practical Non-Destructive Testing (Ninth Reprint, 3rd ed.). Narosa Publishing House Pvt. Ltd. ISBN 9788173197970. https:\/\/archive.org\/details\/practicalnondest0000rajb .   \n \n\n\u2191 Huang, Songling; Wang, Shen (2016). \"Chapter 1: The Electromagnetic Ultrasonic Guided Wave Testing\" (in en). New Technologies in Electromagnetic Non-destructive Testing. Springer Series in Measurement Science and Technology. Singapore: Springer Singapore. pp. 1. doi:10.1007\/978-981-10-0578-7. ISBN 978-981-10-0577-0. https:\/\/books.google.com\/books?id=YuCvCwAAQBAJ&printsec=frontcover .   \n \n\n\u2191 Tian, Guiyun; Gao, Bin, eds. (29 September 2020). Electromagnetic Non-Destructive Evaluation (XXIII). Studies in Applied Electromagnetics and Mechanics. 45. IOS Press. doi:10.3233\/saem45. ISBN 978-1-64368-118-4. https:\/\/books.google.com\/books?id=by4NEAAAQBAJ&printsec=frontcover .   \n \n\n\u2191 Jha, Shyam N., ed. (2010) (in en). Nondestructive Evaluation of Food Quality: Theory and Practice. Berlin, Heidelberg: Springer Berlin Heidelberg. doi:10.1007\/978-3-642-15796-7. ISBN 978-3-642-15795-0. https:\/\/books.google.com\/books?id=RXIJu3TRPWEC&printsec=frontcover .   \n \n\n\u2191 Huebschen, Gerhard, ed. (2016). Materials characterization using nondestructive evaluation (NDE) methods. Woodhead Publishing series in electronic and optical materials. Amsterdam ; Boston: Elsevier\/Woodhead Publishing. ISBN 978-0-08-100040-3. OCLC 932174125. https:\/\/books.google.com\/books?id=ZR1rBgAAQBAJ&printsec=frontcover .   \n \n\n\u2191 25.0 25.1 25.2 25.3 Subramaniam, Persis, ed. (2016). The stability and shelf life of food. Woodhead Publishing Series in Food Science, Technology and Nutrition (Second edition ed.). Amsterdam: Elsevier\/WP, Woodhead Publishing. ISBN 978-0-08-100436-4. OCLC 956922925. https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/956922925 .   \n \n\n\u2191 Komitopoulou, E. (2011). \"Microbiological challenge testing of food\". In Kilcast, David; Subramaniam, Persis. Food and beverage stability and shelf life. Woodhead Publishing Series in Food Science, Technology and Nutrition. Oxford: WP, Woodhead Publ. pp. 507\u2013526. ISBN 978-0-85709-254-0. OCLC 838321011. https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/838321011 .   \n \n\n\u2191 27.0 27.1 27.2 Chen, S.-C. (2018). \"Chapter 12: Container Closure Integrity Testing of Primary Containers for Parenteral Products\". In Warne, Nicholas W.; Mahler, Hanns-Christian (in en). Challenges in Protein Product Development. AAPS Advances in the Pharmaceutical Sciences Series. 38. Cham: Springer International Publishing. pp. 257\u2013290. doi:10.1007\/978-3-319-90603-4. ISBN 978-3-319-90601-0. https:\/\/books.google.com\/books?id=LyVhDwAAQBAJ&pg=PA264&dq=Stability,+cycle,+and+challenge+testing .   \n \n\n\u2191 Baughan, Joan Sylvain, ed. (2021). Global Legislation for Food Contact Materials. Woodhead Publishing Series in Food Science, Technology and Nutrition (Second edition ed.). Oxford: Woodhead Publishing. ISBN 978-0-12-821181-6. OCLC on1272898230. https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/on1272898230 .   \n \n\n\u2191 Balogh, M.P. (2011). \"Testing the Critical Interface: Leachables and Extractables\". LCGC North America 29 (6): 492\u2013501. https:\/\/www.chromatographyonline.com\/view\/testing-critical-interface-leachables-and-extractables .   \n \n\n\u2191 \"Extractables and leachables testing (E&Ls)\". Leeder Analytical. https:\/\/leeder-analytical.com\/extractables-and-leachables-testing\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"What Do I Need To Know About Nutrition Testing for My Beverage Brand?\". BevSource. 5 May 2023. https:\/\/www.bevsource.com\/news\/what-do-i-need-know-about-nutrition-testing-my-beverage-brand .   \n \n\n\u2191 \"Code of Practice on Food Allergen Management for Food Business Operators, CXC 80-2020\" (PDF). Codex Alimentarius. 2020. https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B80-2020%252FCXC_080e.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 Daniel, D. (October 2021). \"poka-yoke\". TechTarget ERP - Definition. https:\/\/www.techtarget.com\/searcherp\/definition\/poka-yoke . Retrieved 05 May 2023 .   \n \n\n\u2191 Dogan, O.; Cebeci, U. (2021). \"Chapter 1: An Integrated Quality Tools Approach for New Product Development\". In Garc\u00eda Alcaraz, Jorge Luis; S\u00e1nchez-Ram\u00edrez, Cuauht\u00e9moc; Gil L\u00f3pez, Alfonso Jes\u00fas (in en). Techniques, Tools and Methodologies Applied to Quality Assurance in Manufacturing. Cham: Springer International Publishing. pp. 3\u201322. doi:10.1007\/978-3-030-69314-5. ISBN 978-3-030-69313-8. https:\/\/link.springer.com\/10.1007\/978-3-030-69314-5 .   \n \n\n\u2191 Baukh, O. (14 October 2020). \"Pre-production processes in garment manufacturing\". Techpacker. https:\/\/techpacker.com\/blog\/manufacturing\/pre-production-processes-in-garment-manufacturing\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Filing a Pre-manufacture Notice with EPA\". Reviewing New Chemicals under the Toxic Substances Control Act (TSCA). U.S. Environmental Protection Agency. 26 October 2022. https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/filing-pre-manufacture-notice-epa . Retrieved 05 May 2023 .   \n \n\n\u2191 Anjoran, R. (February 2010). \"Basic Quality Control Concepts\". QualityInspection.org. https:\/\/qualityinspection.org\/quality-control-basics\/ . Retrieved 05 May 2023 .   \n \n\n\u2191 Malsam, W. (6 December 2022). \"Quality Control in Manufacturing: A Quick Guide\". ProectManager.com. https:\/\/www.projectmanager.com\/blog\/quality-control-manufacturing . Retrieved 05 May 2023 .   \n \n\n\u2191 Seo, K.H.; Brackett, R.E. (1 January 2005). \"Rapid, Specific Detection of Enterobacter sakazakii in Infant Formula Using a Real-Time PCR Assay\" (in en). Journal of Food Protection 68 (1): 59\u201363. doi:10.4315\/0362-028X-68.1.59. https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0362028X22009000 .   \n \n\n\u2191 Richardson, M. (30 August 2018). \"Controlling product quality with hardness testing\". Aerospace Manufacturing. https:\/\/www.aero-mag.com\/controlling-product-quality-with-hardness-testing . Retrieved 05 May 2023 .   \n \n\n\u2191 Downey, Gerard (2016) (in English). Advances in Food Authenticity Testing.. S.l.: Woodhead Publishing.. pp. 798. ISBN 978-0-08-100233-9. OCLC 1096681184. https:\/\/books.google.com\/books?id=Q-8QCgAAQBAJ&printsec=frontcover .   \n \n\n\u2191 Tan, Choon Hui; Kong, Ianne; Irfan, Umair; Solihin, Mahmud Iwan; Pui, Liew Phing (2021). \"Edible Oils Adulteration: A Review on Regulatory Compliance and Its Detection Technologies\" (in en). Journal of Oleo Science 70 (10): 1343\u20131356. doi:10.5650\/jos.ess21109. ISSN 1345-8957. https:\/\/www.jstage.jst.go.jp\/article\/jos\/70\/10\/70_ess21109\/_article .   \n \n\n\u2191 U.S. Consumer Product Safety Commission (2023). \"Toy Safety Business Guidance & Small Entity Compliance Guide\". https:\/\/www.cpsc.gov\/Business--Manufacturing\/Business-Education\/Toy-Safety-Business-Guidance-and-Small-Entity-Compliance-Guide . Retrieved 05 May 2023 .   \n \n\n\u2191 Douglas, S. (21 February 2022). \"FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors\". LIMSwiki.org. https:\/\/www.limswiki.org\/index.php\/LII:FDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods:_Considerations_for_Labs_and_Informatics_Vendors . Retrieved 07 December 2022 .   \n \n\n\u2191 U.S. Consumer Product Safety Commission (2023). \"Third-Party Testing Laboratory Accreditation & Small Entity Compliance Guide\". https:\/\/www.cpsc.gov\/Business--Manufacturing\/Testing-Certification\/Lab-Accreditation . Retrieved 05 May 2023 .   \n \n\n\u2191 46.0 46.1 46.2 Ho, Kai-Lai Grace; Sandoval, Alex (2020), Demirci, Ali; Feng, Hao; Krishnamurthy, Kathiravan, eds., \"Sanitation Standard Operating Procedures (SSOPs)\" (in en), Food Safety Engineering (Cham: Springer International Publishing): 175\u2013190, doi:10.1007\/978-3-030-42660-6_7, ISBN 978-3-030-42659-0, http:\/\/link.springer.com\/10.1007\/978-3-030-42660-6_7   \n \n\n\u2191 Schmidt, Ronald H.; Piotter, Helen M. (2020), Demirci, Ali; Feng, Hao; Krishnamurthy, Kathiravan, eds., \"The Hygienic\/Sanitary Design of Food and Beverage Processing Equipment\" (in en), Food Safety Engineering (Cham: Springer International Publishing): 267\u2013332, doi:10.1007\/978-3-030-42660-6_12, ISBN 978-3-030-42659-0, http:\/\/link.springer.com\/10.1007\/978-3-030-42660-6_12   \n \n\n\u2191 48.0 48.1 n.a. (3 April 2020). \"Selecting materials for standard parts in the food and beverage industry: a buyers\u2019 guide\". Engineering Update. https:\/\/engineering-update.co.uk\/2020\/04\/03\/selecting-materials-for-standard-parts-in-the-food-and-beverage-industry-a-buyers-guide\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 \"Why Manufacturers Should Care About Calibration\". Advanced Technology Services, Inc. 2020. https:\/\/www.advancedtech.com\/blog\/why-manufacturers-should-care-about-calibration\/ . Retrieved 05 May 2023 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 21:49.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 3 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","f5c58bc41bd3b4f5fc4356c7aea9ef5c_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Introduction_to_manufacturing_laboratories_Laboratory_roles_and_activities_in_the_industry rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Introduction_to_manufacturing_laboratories_Laboratory_roles_and_activities_in_the_industry skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction to manufacturing laboratories\/Laboratory roles and activities in the industry<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h3><span class=\"mw-headline\" id=\"1.2_Laboratory_roles_and_activities_in_the_industry\">1.2 Laboratory roles and activities in the industry<\/span><\/h3>\n<p>Today, the \"manufacturing laboratory\" is a complex entity that goes beyond the general idea of a lab making or researching things. Many of the historical aspects discussed prior still hold today, but other aspects have changed. As indicated in the introduction, the world of manufacturing encompasses a wide swath of industries and sub-industries, each with their own nuances. Given the nuances of pharmaceutical manufacturing, food and beverage development, petrochemical extraction and use, and other industries, it's difficult to make broad statements about manufacturing laboratories in general. However, the rest of this guide will attempt to do just that, while at times pointing out a few of those nuances found in specific industries.\n<\/p><p>The biggest area of commonality is found, unsurprisingly, in the roles manufacturing-based labs play today, as well as the types of lab activities they're conducting within those roles. These roles prove to be important in the greater scheme of industry activities, in turn providing a number of benefits to society. As gleaned from prior discussion, as well as other sources, these laboratory roles can be broadly broken into three categories: research and development (R&D), pre-manufacturing and manufacturing, and post-production regulation and security. Additionally, each of these categories has its own types of laboratory activities. \n<\/p><p>The scientific disciplines that go into these laboratory roles and activities is as diverse as the manufacturing industries and sub-industries that make up the manufacturing world. For example, the \nfood and beverage laboratory taps into disciplines such as <a href=\"https:\/\/www.limswiki.org\/index.php\/Biochemistry\" title=\"Biochemistry\" class=\"wiki-link\" data-key=\"17365d4e36341ee64e5637b81c21fc08\">biochemistry<\/a>, <a href=\"https:\/\/www.limswiki.org\/index.php\/Biotechnology\" title=\"Biotechnology\" class=\"wiki-link\" data-key=\"115005039d4cf0b4ef55ec14dc6d66da\">biotechnology<\/a>, <a href=\"https:\/\/www.limswiki.org\/index.php\/Chemical_engineering\" title=\"Chemical engineering\" class=\"wiki-link\" data-key=\"1cd655884711cddfe28333e764bbfde0\">chemical engineering<\/a>, <a href=\"https:\/\/www.limswiki.org\/index.php\/Chemistry\" title=\"Chemistry\" class=\"wiki-link\" data-key=\"792a1b261a4ecc7803e3f7f1de2dbda1\">chemistry<\/a>, fermentation science, materials science, <a href=\"https:\/\/www.limswiki.org\/index.php\/Microbiology\" title=\"Microbiology\" class=\"wiki-link\" data-key=\"920bf32dc9c9cf492c58c4c5484df41f\">microbiology<\/a>, molecular gastronomy, and nutrition.<sup id=\"rdp-ebb-cite_ref-NolletHand15_1-0\" class=\"reference\"><a href=\"#cite_note-NolletHand15-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NielsenFood15_2-0\" class=\"reference\"><a href=\"#cite_note-NielsenFood15-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DouglasTheLabs22_3-0\" class=\"reference\"><a href=\"#cite_note-DouglasTheLabs22-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-4\" class=\"reference\"><a href=\"#cite_note-4\">[4]<\/a><\/sup> However, the paper and printing industry taps into disciplines such as biochemistry, <a href=\"https:\/\/www.limswiki.org\/index.php\/Biology\" title=\"Biology\" class=\"wiki-link\" data-key=\"196c1c084b803a400f06d276f1cc4dbd\">biology<\/a>, chemistry, environmental science, engineering, forestry, and physics.<sup id=\"rdp-ebb-cite_ref-BajpaiEnviro10_5-0\" class=\"reference\"><a href=\"#cite_note-BajpaiEnviro10-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-6\" class=\"reference\"><a href=\"#cite_note-6\">[6]<\/a><\/sup> By extension, the reader can imagine that these and other industries also have a wide variety of laboratory techniques associated with their R&D, manufacturing, and post-production activities.\n<\/p><p>The following subsections more closely examine the three roles manufacturing-based labs can play, as well as a few examples of lab-related activities found within those roles.\n<\/p>\n<h4><span id=\"rdp-ebb-1.2.1_R&D_roles_and_activities\"><\/span><span class=\"mw-headline\" id=\"1.2.1_R.26D_roles_and_activities\">1.2.1 R&D roles and activities<\/span><\/h4>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Food_Safety_Lab_(Gibson_-_52032197020.jpg\" class=\"image wiki-link\" data-key=\"9a85b9ba493a21c07d02ebada1bca6e3\"><img alt=\"Food Safety Lab (Gibson - 52032197020.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/4\/46\/Food_Safety_Lab_%28Gibson_-_52032197020.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>The National Institute of Standards and Technology (NIST) and its Technology Partnerships Office offer a detailed definition of manufacturing-related R&D as an activity \"aimed at increasing the competitive capability of manufacturing concerns,\" and that \"encompasses improvements in existing methods or processes, or wholly new processes, machines or system.\"<sup id=\"rdp-ebb-cite_ref-NISTDefin19_7-0\" class=\"reference\"><a href=\"#cite_note-NISTDefin19-7\">[7]<\/a><\/sup> They break this down into four different technology levels<sup id=\"rdp-ebb-cite_ref-NISTDefin19_7-1\" class=\"reference\"><a href=\"#cite_note-NISTDefin19-7\">[7]<\/a><\/sup>:\n<\/p><ul><li>Unit process-level technologies that create or improve manufacturing processes,<\/li>\n<li>Machine-level technologies that create or improve manufacturing equipment,<\/li>\n<li>Systems-level technologies for innovation in the manufacturing enterprise, and<\/li>\n<li>Environment- or societal-level technologies that improve workforce abilities and manufacturing competitiveness.<\/li><\/ul>\n<p>Obviously, this definition applies to actual development of and innovation towards methods of improving and streamlining manufacturing processes. However, this same concept can, in part, can be applied to the actual products made in a manufacturing plant. Not only does product-based R&D focus on improving \"existing methods and processes,\" but it also focuses on \"manufacturing competitiveness\" by developing new and innovating existing products that meet end users' needs. Manufacturing-based R&D laboratories play an important role in this regard.\n<\/p><p>The laboratory participating in this role is performing one or more tasks that relate to the development or improvement of a manufactured good. This often leads to a commercial formulation, process, or promising insight into a product. The R&D lab may appear outside the manufacturing facility proper, but not necessarily always. Some manufacturing companies may have an entire research complex dedicated to creating and improving some aspect of their products.<sup id=\"rdp-ebb-cite_ref-MonBreak16_8-0\" class=\"reference\"><a href=\"#cite_note-MonBreak16-8\">[8]<\/a><\/sup> Other companies may take their R&D to a third-party consulting lab dedicated to conducting development and formulation activities for manufacturers.<sup id=\"rdp-ebb-cite_ref-BSCommForm_9-0\" class=\"reference\"><a href=\"#cite_note-BSCommForm-9\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GudeSol19_10-0\" class=\"reference\"><a href=\"#cite_note-GudeSol19-10\">[10]<\/a><\/sup> Industrial research activities aren't confined to manufacturers, however. Some higher education institutions provide laboratory-based research and development opportunities to students engaging in work-study programs, often in partnership with some other commercial enterprise.<sup id=\"rdp-ebb-cite_ref-HartFoodBev_11-0\" class=\"reference\"><a href=\"#cite_note-HartFoodBev-11\">[11]<\/a><\/sup> \n<\/p><p>The following types of lab-related activities may be associated with the R&D role:\n<\/p><p><b>Overall product development and innovation<\/b>: Jain <i>et al.<\/i> note in their book on managing R&D activities that in 2010, 60 percent of U.S. R&D was focused on product development, while 22 percent focused on applied research and 18 percent on basic research. However, they also argue that any R&D lab worth its weight should have a mix of these activities, while also including customer participation in the needs assessment and innovation activities that take place in product development and other research activities. Jain <i>et al.<\/i> define a manufacturer's innovation activities as \"combining understanding and invention in the form of socially useful and affordable products and processes.\"<sup id=\"rdp-ebb-cite_ref-12\" class=\"reference\"><a href=\"#cite_note-12\">[12]<\/a><\/sup> As the definition denotes, newly developed products (\"offerings\") and processes (usually which improve some level of efficiency and effectiveness) come out of innovation activities. Additionally, platforms that turn existing components or building blocks into a new derivative offering (e.g., a new model or \"generation\" of product), as well as \"solutions that solve end-to-end customer problems,\" can be derived from innovation. Those activities can focus on more risky radical innovation to a new product or take a more cautious incremental approach to improvements on existing products.<sup id=\"rdp-ebb-cite_ref-13\" class=\"reference\"><a href=\"#cite_note-13\">[13]<\/a><\/sup> \n<\/p><p><b>Reformulation<\/b>: Reformulation involves the material substitution of one or more raw materials used in the production of a product to accomplish some stated goal. That goal may be anything from reducing the toxicity or volume of wastes generated<sup id=\"rdp-ebb-cite_ref-:0_14-0\" class=\"reference\"><a href=\"#cite_note-:0-14\">[14]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-:1_15-0\" class=\"reference\"><a href=\"#cite_note-:1-15\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-:2_16-0\" class=\"reference\"><a href=\"#cite_note-:2-16\">[16]<\/a><\/sup> and improving the overall healthiness of the product<sup id=\"rdp-ebb-cite_ref-:3_17-0\" class=\"reference\"><a href=\"#cite_note-:3-17\">[17]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-:4_18-0\" class=\"reference\"><a href=\"#cite_note-:4-18\">[18]<\/a><\/sup>, to transitioning from traditional holistic medicine approaches to more modern biomedical approaches.<sup id=\"rdp-ebb-cite_ref-:5_19-0\" class=\"reference\"><a href=\"#cite_note-:5-19\">[19]<\/a><\/sup> Examples of products that have seen reformulation by manufacturers include: \n<\/p>\n<ul><li>Paints and other coatings<sup id=\"rdp-ebb-cite_ref-:0_14-1\" class=\"reference\"><a href=\"#cite_note-:0-14\">[14]<\/a><\/sup>,<\/li>\n<li>Fuels such as gasoline<sup id=\"rdp-ebb-cite_ref-:2_16-1\" class=\"reference\"><a href=\"#cite_note-:2-16\">[16]<\/a><\/sup>,<\/li>\n<li>Foods and beverages<sup id=\"rdp-ebb-cite_ref-:3_17-1\" class=\"reference\"><a href=\"#cite_note-:3-17\">[17]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-:4_18-1\" class=\"reference\"><a href=\"#cite_note-:4-18\">[18]<\/a><\/sup>, and<\/li>\n<li>Pharmaceuticals and cosmetics.<sup id=\"rdp-ebb-cite_ref-:1_15-1\" class=\"reference\"><a href=\"#cite_note-:1-15\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-:5_19-1\" class=\"reference\"><a href=\"#cite_note-:5-19\">[19]<\/a><\/sup><\/li><\/ul>\n<p>In the end, reformulation is a means for improving impacts on the end user, the environment, or even the long-term budget of the manufacturer. The type of lab activities associated with reformulation largely varies by product; the laboratory methods used to reformulate gasoline may be quite different from those in a food and beverage lab. Reformulation can also be a complicated process, as found with pharmaceutical products. The reformulated product \"must have the same therapeutic effect, stability, and purity profile\" as the original, while maintaining pleasing aesthetic qualities to the end user. Adding to the problem is regulatory approval times of such pharmaceutical reformulations.<sup id=\"rdp-ebb-cite_ref-:1_15-2\" class=\"reference\"><a href=\"#cite_note-:1-15\">[15]<\/a><\/sup>\n<\/p><p><b>Nondestructive testing and materials characterization<\/b>: Raj <i>et al.<\/i> describe nondestructive testing (NDT) as \"techniques that are based on the application of physical principles employed for the purpose of determining the characteristics of materials or components or systems and for detecting and assessing the inhomogeneities and harmful defects without impairing the usefulness of such materials or components or systems.\"<sup id=\"rdp-ebb-cite_ref-:7_20-0\" class=\"reference\"><a href=\"#cite_note-:7-20\">[20]<\/a><\/sup> NDT has many applications, including with food, steel, petroleum, medical devices, transportation, and utilities manufacturing, as well as electronics manufacturing.<sup id=\"rdp-ebb-cite_ref-21\" class=\"reference\"><a href=\"#cite_note-21\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-22\" class=\"reference\"><a href=\"#cite_note-22\">[22]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-23\" class=\"reference\"><a href=\"#cite_note-23\">[23]<\/a><\/sup> It also plays an important role in materials testing and characterization.<sup id=\"rdp-ebb-cite_ref-24\" class=\"reference\"><a href=\"#cite_note-24\">[24]<\/a><\/sup> NDT and materials testing is often used as a quality control mechanism during manufacturing (see the next subsection), but it can also be used during the initial R&D process to determine if a prototype is functioning as intended or a material is satisfactory for a given application.<sup id=\"rdp-ebb-cite_ref-:7_20-1\" class=\"reference\"><a href=\"#cite_note-:7-20\">[20]<\/a><\/sup> \n<\/p><p><b>Stability, cycle, and challenge testing<\/b>: Multiple deteriorative catalysts can influence the shelf life of a manufactured product, from microbiological contaminants and chemical deterioration to storage conditions and the packaging itself. As such, there are multiple approaches to taming the effects of those catalysts, from introducing additives to improving the packaging.<sup id=\"rdp-ebb-cite_ref-SubramaniamTheStab16_25-0\" class=\"reference\"><a href=\"#cite_note-SubramaniamTheStab16-25\">[25]<\/a><\/sup> However, stability, cycle, and challenge testing must be conducted on many products to determine what deleterious factors are in play. The analytical techniques applied in stability, cycle, and challenge testing will vary based on, to a large degree, the product matrix and its chemical composition.<sup id=\"rdp-ebb-cite_ref-SubramaniamTheStab16_25-1\" class=\"reference\"><a href=\"#cite_note-SubramaniamTheStab16-25\">[25]<\/a><\/sup> Microbiological testing is sure to be involved, particularly in challenge testing, which simulates what could happen to a product if contaminated by a microorganism and placed in a representative storage condition.<sup id=\"rdp-ebb-cite_ref-26\" class=\"reference\"><a href=\"#cite_note-26\">[26]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-:6_27-0\" class=\"reference\"><a href=\"#cite_note-:6-27\">[27]<\/a><\/sup> Calorimetry, spectrophotometry, spectroscopy, and hyperspectral imaging may be used to properly assess color, particularly when gauging food quality.<sup id=\"rdp-ebb-cite_ref-SubramaniamTheStab16_25-2\" class=\"reference\"><a href=\"#cite_note-SubramaniamTheStab16-25\">[25]<\/a><\/sup> Other test types that may be used include water content, texture, viscosity, dispersibility, glass transition, and gas chromatography.<sup id=\"rdp-ebb-cite_ref-SubramaniamTheStab16_25-3\" class=\"reference\"><a href=\"#cite_note-SubramaniamTheStab16-25\">[25]<\/a><\/sup> In the end, the substrate being examined will be a major determiner of what kind of lab methods are used. The lab method chosen for stability, cycle, and challenge testing should optimally be one that errs on the side of caution and is appropriate to the test, even if it takes longer. As Chen notes: \"A longer test cycle is less a concern for stability protocol as the study typically has a limited number of samples. Applying a less reliable method to the limited number of samples in a stability study can be problematic.\"<sup id=\"rdp-ebb-cite_ref-:6_27-1\" class=\"reference\"><a href=\"#cite_note-:6-27\">[27]<\/a><\/sup>\n<\/p><p><b>Packaging analysis and extractable and leachable testing<\/b>: Materials that contact pharmaceuticals, foods and beverages, cosmetics, and more receive special regulatory consideration in various parts of the world. This includes alloys, bioplastics, can coatings, glass, metals, regenerated cellulose materials, paper, paperboard, plastics, printing inks, rubber, textiles, waxes, and woods.<sup id=\"rdp-ebb-cite_ref-28\" class=\"reference\"><a href=\"#cite_note-28\">[28]<\/a><\/sup> As such, meeting regulatory requirements and making inroads with packaging development can be a complicated process. Concerns of chemicals and elements that can be extracted or leach into sensitive products add another layer of complexity to developing and choosing packaging materials for many manufactured goods. This requires extractable and leachable testing at various phases of product development to ensure the packaging selected during formulation is safe and effective.<sup id=\"rdp-ebb-cite_ref-:6_27-2\" class=\"reference\"><a href=\"#cite_note-:6-27\">[27]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BaloghTesting11_29-0\" class=\"reference\"><a href=\"#cite_note-BaloghTesting11-29\">[29]<\/a><\/sup> Extractable and leachable testing for packaging could involve a number of techniques ranging from gas and liquid chromatography to ion chromatography and inductively coupled plasma mass spectrometry.<sup id=\"rdp-ebb-cite_ref-LAExtract_30-0\" class=\"reference\"><a href=\"#cite_note-LAExtract-30\">[30]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"1.2.2_Pre-manufacturing_and_manufacturing_roles_and_activities\">1.2.2 Pre-manufacturing and manufacturing roles and activities<\/span><\/h4>\n<p>The laboratory participating in these roles is performing one or more tasks that relate to the preparative (i.e., pre-manufacturing) or <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_control\" title=\"Quality control\" class=\"wiki-link\" data-key=\"1e0e0c2eb3e45aff02f5d61799821f0f\">quality control<\/a> (QC; i.e., manufacturing) activities of production. An example of preparative work is conducting allergen, calorie, and nutrition testing for a formulated food and beverage product. Calorie and nutrition testing\u2014conducted in part as a means of meeting regulation-driven labeling requirements\u2014lands firmly in the role of pre-manufacturing activity, most certainly after commercial formulation and packing requirements have been finalized but before the formal manufacturing process has begun.<sup id=\"rdp-ebb-cite_ref-BSNutTest_31-0\" class=\"reference\"><a href=\"#cite_note-BSNutTest-31\">[31]<\/a><\/sup> Allergen testing works in a similar fashion, though the manufacturer ideally uses a full set of best practices for food allergen management and testing, from confirming allergens (and correct labeling) from ingredients ordered to performing final production line cleanup (e.g., when a new allergen-free commercial formulation is being made or an unintended contamination has occurred).<sup id=\"rdp-ebb-cite_ref-CA80-2020_32-0\" class=\"reference\"><a href=\"#cite_note-CA80-2020-32\">[32]<\/a><\/sup> These types of pre-production analyses aren't uncommon to other types of manufacturing, discussed below.\n<\/p><p>As for in-process manufacturing QC, some QC and <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_assurance\" title=\"Quality assurance\" class=\"wiki-link\" data-key=\"2ede4490f0ea707b14456f44439c0984\">quality assurance<\/a> (QA) methods may already be built into the manufacturing process in-line, not requiring a lab. For example, poka-yoke mechanisms that inhibit, correct, or highlight errors as they occur, as close to the source as possible\u2014may be built in-line to a manufacturing process to prevent a process from continuing should a detectable error occur, or until a certain condition has been reached.<sup id=\"rdp-ebb-cite_ref-DanielPoka21_33-0\" class=\"reference\"><a href=\"#cite_note-DanielPoka21-33\">[33]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-34\" class=\"reference\"><a href=\"#cite_note-34\">[34]<\/a><\/sup> However, despite the value of inline QC\/QA, these activities also happen beyond the production line, in the laboratory (discussed further, below). \n<\/p><p>The following types of lab-related activities may be associated with the pre-manufacturing and manufacturing role:\n<\/p><p><b>Various pre-manufacturing analyses<\/b>: Also known as pre-production, some level of laboratory activity takes place here. Like the previously mentioned food and beverage industry, the garment manufacturing industry, for example, will have its own laboratory-based pre-production activities, including testing various raw material samples for potential use and quality testing pre-production samples before deciding to go into full production.<sup id=\"rdp-ebb-cite_ref-BaukhPreprod20_35-0\" class=\"reference\"><a href=\"#cite_note-BaukhPreprod20-35\">[35]<\/a><\/sup> In another example, a manufacturer intending to produce \"a new chemical substance for a non-exempt commercial purpose\" in the U.S. must submit a pre-manufacture notice to the Environmental Protection Agency (EPA), which must include \"test data on the effect to human health or the environment.\"<sup id=\"rdp-ebb-cite_ref-EPAFiling22_36-0\" class=\"reference\"><a href=\"#cite_note-EPAFiling22-36\">[36]<\/a><\/sup> Given this regulatory requirement, some final pre-approval testing much occur to ensure the chemical meets regulatory requirements before full manufacturing processes begin.\n<\/p><p><b>Quality control testing<\/b>: While QC testing can appear in multiple manufacturing laboratory roles, it's most noticeable in the pre-manufacturing and manufacturing role. Manufacturers in many industries have set up formal testing laboratories to better ensure that their products conform to a determined set of accepted standards, whether those standards come from a standards-setting organization or are internally derived. QC testing is a multi-pronged approach that includes both non-laboratory and laboratory analyses, whether it is in real-time or periodically during manufacturing activities. The previously mentioned inline poka-yoke mechanisms provide an example of non-laboratory QC activities. However, when rigorous mechanical, chemical, or some other form of testing of a manufactured product is required at different stages of production, a laboratory will be involved. This type of in-process inspection occurs after roughly 10 to 30 percent of products are completed.<sup id=\"rdp-ebb-cite_ref-AnjoranBasic10_37-0\" class=\"reference\"><a href=\"#cite_note-AnjoranBasic10-37\">[37]<\/a><\/sup> Manufacturers can take multiple approaches to QC testing, depending on the circumstances of manufacturing. This includes 100 percent inspection methods, Six Sigma approaches, X-bar charting, total quality management, statistical quality control, Taguchi approaches, and more.<sup id=\"rdp-ebb-cite_ref-MalsamQual22_38-0\" class=\"reference\"><a href=\"#cite_note-MalsamQual22-38\">[38]<\/a><\/sup> \n<\/p><p>The actual types of analyses going on during QC will entirely depend on the material being tested, the functionality of the item, and the intended goal of testing. For example, <a href=\"https:\/\/www.limswiki.org\/index.php\/Polymerase_chain_reaction\" title=\"Polymerase chain reaction\" class=\"wiki-link\" data-key=\"f6569fb01ef396379f9f4efa4527e715\">polymerase chain reaction<\/a> (PCR) testing of infant formula for the pathogenic bacterium <i>Cronobacter sakazakii<\/i><sup id=\"rdp-ebb-cite_ref-39\" class=\"reference\"><a href=\"#cite_note-39\">[39]<\/a><\/sup> during production runs is entirely different from periodic Rockwell, Brinell, or Vickers hardness testing of aerospace fasteners.<sup id=\"rdp-ebb-cite_ref-RichardsonControl18_40-0\" class=\"reference\"><a href=\"#cite_note-RichardsonControl18-40\">[40]<\/a><\/sup> NDT and materials testing, discussed in the prior subsection about R&D, can also occur during the various phases of manufacturing, as part of an overall quality control effort.<sup id=\"rdp-ebb-cite_ref-:7_20-2\" class=\"reference\"><a href=\"#cite_note-:7-20\">[20]<\/a><\/sup> \n<\/p>\n<h4><span class=\"mw-headline\" id=\"1.2.3_Post-production_regulation_and_security_roles_and_activities\">1.2.3 Post-production regulation and security roles and activities<\/span><\/h4>\n<div class=\"floatleft\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Infrared_spectrometer_for_screening_for_food_adulteration,_in_CAFIA_laboratory,_Czech_Republic.png\" class=\"image wiki-link\" data-key=\"3f02748ea28e0fe64ba48c5afeb89f7d\"><img alt=\"Infrared spectrometer for screening for food adulteration, in CAFIA laboratory, Czech Republic.png\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/0\/0f\/Infrared_spectrometer_for_screening_for_food_adulteration%2C_in_CAFIA_laboratory%2C_Czech_Republic.png\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>The laboratory participating in these roles is performing one or more tasks that relate to the post-production examination of products for regulatory, security, or accreditation purposes. Labs are often third parties accrediting a producer to a set of standards, ensuring regulatory compliance, conducting authenticity and adulteration testing, conducting security checks at borders, and applying contamination testing as part of an overall effort to track down contamination sources. In addition to ensuring a safer product, society also benefits from these and similar labs by better holding producers legally accountable for their production methods and obligations.\n<\/p><p>The following types of lab-related activities may be associated with the post-production regulation and security role:\n<\/p><p><b>Authenticity and adulteration testing<\/b>: This type of testing is largely conducted to ensure products ingested, injected, inserted, and\/or handled by humans and animals are safe to use and authentic to consumer expectations. Anything from food and pharmaceuticals to children's toys and fishing sinkers may be tested to ensure they contain what the manufacturer claims is contained in them. Foods and beverages, for example, are subject to a variety of food supply chain laws and regulations across national and international borders. As such, scientists have developed a number of analytical techniques \"to identify foods or food ingredients that are in breach of labeling requirement and may consequently be adulterated.\" Among these techniques are DNA fingerprinting; visible, ultraviolet, infrared, fluorescence emission, and nuclear magnetic resonance spectroscopy; mass spectrometry; isotopic analysis; <a href=\"https:\/\/www.limswiki.org\/index.php\/Chromatography\" title=\"Chromatography\" class=\"wiki-link\" data-key=\"2615535d1f14c6cffdfad7285999ad9d\">chromatography<\/a>; <a href=\"https:\/\/www.limswiki.org\/index.php\/Polymerase_chain_reaction\" title=\"Polymerase chain reaction\" class=\"wiki-link\" data-key=\"f6569fb01ef396379f9f4efa4527e715\">polymerase chain reaction<\/a>; differential scanning calorimetry; chemometric; and \"electric nose and tongue\" techniques.<sup id=\"rdp-ebb-cite_ref-41\" class=\"reference\"><a href=\"#cite_note-41\">[41]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-42\" class=\"reference\"><a href=\"#cite_note-42\">[42]<\/a><\/sup> In the United States, certain toys are subject to being tested and certified to the ASTM F963-17 standard by the U.S. Consumer Product Safety Commission (CPSC), with some toys being tested for heavy metals in surface coatings, nitrosamines in rubber, and contaminates in pastes, putties, and gels.<sup id=\"rdp-ebb-cite_ref-43\" class=\"reference\"><a href=\"#cite_note-43\">[43]<\/a><\/sup> Authenticity and adulteration testing may occur during post-production as part of meeting a manufacturer's regulatory requirements, or it may be conducted at a state or national border as part of a set of international trade rules. In most cases, the testing will be done by a third party laboratory or a regulatory body.\n<\/p><p><b>Accreditation-led testing<\/b>: In some cases, governments and other regulatory bodies provide a higher standard for a manufacturing-related laboratory process, which requires accreditation to that standard. For example, labs optionally accredited to <a href=\"https:\/\/www.limswiki.org\/index.php\/LII:FDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods:_Considerations_for_Labs_and_Informatics_Vendors\" title=\"LII:FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors\" class=\"wiki-link\" data-key=\"db3a91773a3d971ad1c5d4df3a7cfd32\">Laboratory Accreditation for Analyses of Foods<\/a> (LAAF) rules are recognized by the FDA as meeting the process requirements of the LAAF program for testing of specific sprouts, eggs, water, and certain foods being considered for import into the country.<sup id=\"rdp-ebb-cite_ref-DouglasFDA22_44-0\" class=\"reference\"><a href=\"#cite_note-DouglasFDA22-44\">[44]<\/a><\/sup> LAAF represents one of several legal and regulatory forces driving accreditation of manufacturing-related laboratories to a higher standard. It also means greater potential for more testing opportunities for the third-party lab wishing to expand into enforcement and security roles. Similarly, the previously mentioned CPSC accredits labs to perform the specific testing required by children's product safety rules.<sup id=\"rdp-ebb-cite_ref-45\" class=\"reference\"><a href=\"#cite_note-45\">[45]<\/a><\/sup> Again, as with authenticity and adulteration testing, accreditation-led testing is typically conducted by third-party labs separate from the manufacturer; however, this type of testing is a step above non-accredited labs and their methods, which may be required by certain manufacturers.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"1.2.4_Tangential_laboratory_work\">1.2.4 Tangential laboratory work<\/span><\/h4>\n<p>The following tangential laboratory roles aren't necessarily found directly in the manufacturing center. However, some level of laboratory work is required in these roles, which intersect with the manufacturing industry in some capacity.\n<\/p><p><b>Processing equipment design, monitoring, and sanitation<\/b>: \"Sanitation provides the hygienic conditions required to produce safe food,\" say Ho and Sandoval in chapter seven of <i>Food Safety Engineering<\/i>.<sup id=\"rdp-ebb-cite_ref-HoSanit20_46-0\" class=\"reference\"><a href=\"#cite_note-HoSanit20-46\">[46]<\/a><\/sup> \"Improper sanitation of equipment can potentially introduce hazardous contamination to food and enhance pathogen harborage in the food-processing environment.\"<sup id=\"rdp-ebb-cite_ref-HoSanit20_46-1\" class=\"reference\"><a href=\"#cite_note-HoSanit20-46\">[46]<\/a><\/sup> They note the value of sanitation standard operating procedures (SSOPs) to the production facility, which dictate sanitation methods and frequencies, monitoring methods, and record keeping methods.<sup id=\"rdp-ebb-cite_ref-HoSanit20_46-2\" class=\"reference\"><a href=\"#cite_note-HoSanit20-46\">[46]<\/a><\/sup> These SSOPs are not only driven by good manufacturing practice (GMP) but also appropriate and effective laboratory testing. \n<\/p><p>While Ho and Sandoval focus on food and beverage production, the proper design, monitoring and sanitation of manufacturing equipment extends beyond that industry, into areas such as pharmaceutical production and medical device manufacturing. That foundation of laboratory testing has occurred historically with the both the experience of regulated manufacturers and those scientists engineering and standardizing hygienic solutions for manufacturing industries. Combined, these industry and laboratory experiences have driven regulations and standards on hygienic design throughout the world. Broadly speaking, this has culminated in a set of manufacturing requirements, addressing physical and chemical properties such as being nontoxic, corrosion-resistant, and non-absorbent, to mechanical properties such as being durable and smooth, and operational properties such as being cleanable and low-maintenance.<sup id=\"rdp-ebb-cite_ref-47\" class=\"reference\"><a href=\"#cite_note-47\">[47]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EUSelect20_48-0\" class=\"reference\"><a href=\"#cite_note-EUSelect20-48\">[48]<\/a><\/sup> In turn, these properties require laboratory and engineering knowledge about metals, alloys, plastics, and many other materials.<sup id=\"rdp-ebb-cite_ref-EUSelect20_48-1\" class=\"reference\"><a href=\"#cite_note-EUSelect20-48\">[48]<\/a><\/sup> Here we find multi-disciplinary knowledge in materials science, microbiology, chemistry, physics, and more, implying a corresponding necessity for knowledge on a wide variety of testing methods.\n<\/p><p><b>Calibration<\/b>: Just as laboratories require their precision equipment be regularly calibrated to specific tolerances, manufacturers too require their equipment to be calibrated. Multiple types of equipment along the production line require the utmost in accuracy and consistency in order to create a finished product that is safe and fully functional. Manufacturers who fall behind on their calibration obligations are more prone to higher rates of rejected components and products, more cost overruns, more missed deadlines, and greater reputation damage.<sup id=\"rdp-ebb-cite_ref-ATSWhy20_49-0\" class=\"reference\"><a href=\"#cite_note-ATSWhy20-49\">[49]<\/a><\/sup> As such, manufacturers increasingly depend on industrial maintenance providers, OEM providers, and laboratories to ensure their instruments and equipment meet operational tolerances.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-NolletHand15-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NolletHand15_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Nollet, L.M.L.; Toldr\u00e1, F., ed. (2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=KtAdCgAAQBAJ&printsec=frontcover\" target=\"_blank\"><i>Handbook of Food Analysis (Two Volume Set)<\/i><\/a> (3rd ed.). CRC Press. pp. 1568. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9781482297843<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=KtAdCgAAQBAJ&printsec=frontcover\" target=\"_blank\">https:\/\/books.google.com\/books?id=KtAdCgAAQBAJ&printsec=frontcover<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Handbook+of+Food+Analysis+%28Two+Volume+Set%29&rft.date=2015&rft.pages=pp.%26nbsp%3B1568&rft.edition=3rd&rft.pub=CRC+Press&rft.isbn=9781482297843&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DKtAdCgAAQBAJ%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NielsenFood15-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NielsenFood15_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Nielsen, S. (2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=i5TdyXBiwRsC&printsec=frontcover\" target=\"_blank\"><i>Food Analysis Laboratory Manual<\/i><\/a> (2nd ed.). Springer. pp. 177. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9781441914620<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=i5TdyXBiwRsC&printsec=frontcover\" target=\"_blank\">https:\/\/books.google.com\/books?id=i5TdyXBiwRsC&printsec=frontcover<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Food+Analysis+Laboratory+Manual&rft.aulast=Nielsen%2C+S.&rft.au=Nielsen%2C+S.&rft.date=2015&rft.pages=pp.%26nbsp%3B177&rft.edition=2nd&rft.pub=Springer&rft.isbn=9781441914620&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Di5TdyXBiwRsC%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DouglasTheLabs22-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DouglasTheLabs22_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Douglas, S.E. (July 2022). <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:The_Laboratories_of_Our_Lives:_Labs,_Labs_Everywhere!\/Labs_by_industry:_Part_2\" data-key=\"6257de80f0c813ec14cb33814938b0f8\">\"Labs by industry: Part 2\"<\/a>. <i>The Laboratories of Our Lives: Labs, Labs Everywhere!<\/i> (2nd ed.). LIMSwiki<span class=\"printonly\">. <a rel=\"nofollow\" class=\"external free wiki-link\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:The_Laboratories_of_Our_Lives:_Labs,_Labs_Everywhere!\/Labs_by_industry:_Part_2\" data-key=\"6257de80f0c813ec14cb33814938b0f8\">https:\/\/www.limswiki.org\/index.php\/LII:The_Laboratories_of_Our_Lives:_Labs,_Labs_Everywhere!\/Labs_by_industry:_Part_2<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Labs+by+industry%3A+Part+2&rft.atitle=The+Laboratories+of+Our+Lives%3A+Labs%2C+Labs+Everywhere%21&rft.aulast=Douglas%2C+S.E.&rft.au=Douglas%2C+S.E.&rft.date=July+2022&rft.edition=2nd&rft.pub=LIMSwiki&rft_id=https%3A%2F%2Fwww.limswiki.org%2Findex.php%2FLII%3AThe_Laboratories_of_Our_Lives%3A_Labs%2C_Labs_Everywhere%21%2FLabs_by_industry%3A_Part_2&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-4\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Bhandari, B.; Roos, Y.H. (2012). \"Chapter 1: Food Materials Science and Engineering: An Overview\". In Bhandari, Bhesh; Roos, Yrj\u00f6 H.. <i>Food Materials Science and Engineering<\/i>. Chichester, West Sussex, UK ; Ames, Iowa: Wiley-Blackwell. pp. 1\u201325. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-1-4051-9922-3.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+1%3A+Food+Materials+Science+and+Engineering%3A+An+Overview&rft.atitle=Food+Materials+Science+and+Engineering&rft.aulast=Bhandari%2C+B.%3B+Roos%2C+Y.H.&rft.au=Bhandari%2C+B.%3B+Roos%2C+Y.H.&rft.date=2012&rft.pages=pp.%26nbsp%3B1%E2%80%9325&rft.place=Chichester%2C+West+Sussex%2C+UK+%3B+Ames%2C+Iowa&rft.pub=Wiley-Blackwell&rft.isbn=978-1-4051-9922-3&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BajpaiEnviro10-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BajpaiEnviro10_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Bajpai, P. (2010). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=zjEeUpwepFMC&printsec=frontcover\" target=\"_blank\">\"Chapter 2: Overview of Pulp and Papermaking Processes\"<\/a>. <i>Environmentally Friendly Production of Pulp and Paper<\/i>. John Wiley & Sons. pp. 8\u201345. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780470528105<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=zjEeUpwepFMC&printsec=frontcover\" target=\"_blank\">https:\/\/books.google.com\/books?id=zjEeUpwepFMC&printsec=frontcover<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+2%3A+Overview+of+Pulp+and+Papermaking+Processes&rft.atitle=Environmentally+Friendly+Production+of+Pulp+and+Paper&rft.aulast=Bajpai%2C+P.&rft.au=Bajpai%2C+P.&rft.date=2010&rft.pages=pp.%26nbsp%3B8%E2%80%9345&rft.pub=John+Wiley+%26+Sons&rft.isbn=9780470528105&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DzjEeUpwepFMC%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-6\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation\" id=\"rdp-ebb-CITEREFNyk.C3.A4nen2018\">Nyk\u00e4nen, Panu (2018), S\u00e4rkk\u00e4, Timo; Guti\u00e9rrez-Poch, Miquel; Kuhlberg, Mark, eds., <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/link.springer.com\/10.1007\/978-3-319-94962-8_3\" target=\"_blank\">\"Research and Development in the Finnish Wood Processing and Paper Industry, c. 1850\u20131990\"<\/a>, <i>Technological Transformation in the Global Pulp and Paper Industry 1800\u20132018<\/i> (Cham: Springer International Publishing) <b>23<\/b>: 35\u201364, <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2F978-3-319-94962-8_3\" target=\"_blank\">10.1007\/978-3-319-94962-8_3<\/a>, <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-3-319-94961-1<span class=\"printonly\">, <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/link.springer.com\/10.1007\/978-3-319-94962-8_3\" target=\"_blank\">http:\/\/link.springer.com\/10.1007\/978-3-319-94962-8_3<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 2023-04-13<\/span><\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Research+and+Development+in+the+Finnish+Wood+Processing+and+Paper+Industry%2C+c.+1850%E2%80%931990&rft.jtitle=Technological+Transformation+in+the+Global+Pulp+and+Paper+Industry+1800%E2%80%932018&rft.aulast=Nyk%C3%A4nen&rft.aufirst=Panu&rft.au=Nyk%C3%A4nen%2C%26%2332%3BPanu&rft.date=2018&rft.volume=23&rft.pages=35%E2%80%9364&rft.place=Cham&rft.pub=Springer+International+Publishing&rft_id=info:doi\/10.1007%2F978-3-319-94962-8_3&rft.isbn=978-3-319-94961-1&rft_id=http%3A%2F%2Flink.springer.com%2F10.1007%2F978-3-319-94962-8_3&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NISTDefin19-7\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-NISTDefin19_7-0\">7.0<\/a><\/sup> <sup><a href=\"#cite_ref-NISTDefin19_7-1\">7.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Technology Partnerships Office (31 July 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nist.gov\/tpo\/definition-manufacturing-related-rd\" target=\"_blank\">\"Definition of Manufacturing-related R&D\"<\/a>. National Institute of Standards and Technology<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.nist.gov\/tpo\/definition-manufacturing-related-rd\" target=\"_blank\">https:\/\/www.nist.gov\/tpo\/definition-manufacturing-related-rd<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Definition+of+Manufacturing-related+R%26D&rft.atitle=&rft.aulast=Technology+Partnerships+Office&rft.au=Technology+Partnerships+Office&rft.date=31+July+2019&rft.pub=National+Institute+of+Standards+and+Technology&rft_id=https%3A%2F%2Fwww.nist.gov%2Ftpo%2Fdefinition-manufacturing-related-rd&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MonBreak16-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MonBreak16_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ir.mondelezinternational.com\/news-releases\/news-release-details\/mondelez-international-breaks-ground-new-research-development\" target=\"_blank\">\"Mondelez International Breaks Ground for New Research & Development Center in Poland\"<\/a>. Mondelez International. 8 June 2016<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/ir.mondelezinternational.com\/news-releases\/news-release-details\/mondelez-international-breaks-ground-new-research-development\" target=\"_blank\">https:\/\/ir.mondelezinternational.com\/news-releases\/news-release-details\/mondelez-international-breaks-ground-new-research-development<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Mondelez+International+Breaks+Ground+for+New+Research+%26+Development+Center+in+Poland&rft.atitle=&rft.date=8+June+2016&rft.pub=Mondelez+International&rft_id=https%3A%2F%2Fir.mondelezinternational.com%2Fnews-releases%2Fnews-release-details%2Fmondelez-international-breaks-ground-new-research-development&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BSCommForm-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BSCommForm_9-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bevsource.com\/news\/why-you-need-commercial-formula\" target=\"_blank\">\"Why You Need A Commercial Formula\"<\/a>. BevSource. 13 August 2022<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.bevsource.com\/news\/why-you-need-commercial-formula\" target=\"_blank\">https:\/\/www.bevsource.com\/news\/why-you-need-commercial-formula<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Why+You+Need+A+Commercial+Formula&rft.atitle=&rft.date=13+August+2022&rft.pub=BevSource&rft_id=https%3A%2F%2Fwww.bevsource.com%2Fnews%2Fwhy-you-need-commercial-formula&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GudeSol19-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GudeSol19_10-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Gude, T. (2019). \"Solutions Commonly Applied in Industry and Outsourced to Expert Laboratories\". In Suman, M.. <i>Food Contact Materials Analysis: Mass Spectrometry Techniques<\/i>. Royal Society of Chemistry. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1039%2F9781788012973-00245\" target=\"_blank\">10.1039\/9781788012973-00245<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9781788017190.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Solutions+Commonly+Applied+in+Industry+and+Outsourced+to+Expert+Laboratories&rft.atitle=Food+Contact+Materials+Analysis%3A+Mass+Spectrometry+Techniques&rft.aulast=Gude%2C+T.&rft.au=Gude%2C+T.&rft.date=2019&rft.pub=Royal+Society+of+Chemistry&rft_id=info:doi\/10.1039%2F9781788012973-00245&rft.isbn=9781788017190&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HartFoodBev-11\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HartFoodBev_11-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hartwick.edu\/about-us\/center-for-craft-food-and-beverage\/\" target=\"_blank\">\"Hartwick College Center for Craft Food & Beverage\"<\/a>. Hartwick College<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.hartwick.edu\/about-us\/center-for-craft-food-and-beverage\/\" target=\"_blank\">https:\/\/www.hartwick.edu\/about-us\/center-for-craft-food-and-beverage\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Hartwick+College+Center+for+Craft+Food+%26+Beverage&rft.atitle=&rft.pub=Hartwick+College&rft_id=https%3A%2F%2Fwww.hartwick.edu%2Fabout-us%2Fcenter-for-craft-food-and-beverage%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-12\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-12\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Jain, Ravi; Triandis, Harry Charalambos; Weick, Cynthia Wagner (2010). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=nSgebaFKwvMC&pg=PA8\" target=\"_blank\">\"Chapter 1: R&D Organizations and Research Categories\"<\/a>. <i>Managing research, development and innovation: Managing the unmanageable<\/i> (3rd ed.). Hoboken, N.J: Wiley. pp. 8. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-470-40412-6<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=nSgebaFKwvMC&pg=PA8\" target=\"_blank\">https:\/\/books.google.com\/books?id=nSgebaFKwvMC&pg=PA8<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+1%3A+R%26D+Organizations+and+Research+Categories&rft.atitle=Managing+research%2C+development+and+innovation%3A+Managing+the+unmanageable&rft.aulast=Jain&rft.aufirst=Ravi&rft.au=Jain%2C%26%2332%3BRavi&rft.au=Triandis%2C%26%2332%3BHarry+Charalambos&rft.au=Weick%2C%26%2332%3BCynthia+Wagner&rft.date=2010&rft.pages=pp.%26nbsp%3B8&rft.edition=3rd&rft.place=Hoboken%2C+N.J&rft.pub=Wiley&rft.isbn=978-0-470-40412-6&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DnSgebaFKwvMC%26pg%3DPA8&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-13\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-13\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Jain, Ravi; Triandis, Harry Charalambos; Weick, Cynthia Wagner (2010). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=nSgebaFKwvMC&pg=PA240\" target=\"_blank\">\"Chapter 12: Models for Implementing Incremental and Radical Innovation\"<\/a>. <i>Managing research, development and innovation: Managing the unmanageable<\/i> (3rd ed.). Hoboken, N.J: Wiley. pp. 240\u2013241. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-470-40412-6<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=nSgebaFKwvMC&pg=PA240\" target=\"_blank\">https:\/\/books.google.com\/books?id=nSgebaFKwvMC&pg=PA240<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+12%3A+Models+for+Implementing+Incremental+and+Radical+Innovation&rft.atitle=Managing+research%2C+development+and+innovation%3A+Managing+the+unmanageable&rft.aulast=Jain&rft.aufirst=Ravi&rft.au=Jain%2C%26%2332%3BRavi&rft.au=Triandis%2C%26%2332%3BHarry+Charalambos&rft.au=Weick%2C%26%2332%3BCynthia+Wagner&rft.date=2010&rft.pages=pp.%26nbsp%3B240%E2%80%93241&rft.edition=3rd&rft.place=Hoboken%2C+N.J&rft.pub=Wiley&rft.isbn=978-0-470-40412-6&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DnSgebaFKwvMC%26pg%3DPA240&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-:0-14\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-:0_14-0\">14.0<\/a><\/sup> <sup><a href=\"#cite_ref-:0_14-1\">14.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Dupont, R. Ryan; Ganesan, Kumar; Theodore, Louis (2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=3m4NDgAAQBAJ&pg=PA382\" target=\"_blank\"><i>Pollution prevention: sustainability, industrial ecology, and green engineering<\/i><\/a> (Second edition ed.). Boca Raton: CRC Press, Taylor & Francis Group, CRC Press is an imprint of the Taylor & Francis Group, an informa business. pp. 382. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-1-4987-4954-1<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=3m4NDgAAQBAJ&pg=PA382\" target=\"_blank\">https:\/\/books.google.com\/books?id=3m4NDgAAQBAJ&pg=PA382<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Pollution+prevention%3A+sustainability%2C+industrial+ecology%2C+and+green+engineering&rft.aulast=Dupont&rft.aufirst=R.+Ryan&rft.au=Dupont%2C%26%2332%3BR.+Ryan&rft.au=Ganesan%2C%26%2332%3BKumar&rft.au=Theodore%2C%26%2332%3BLouis&rft.date=2017&rft.pages=pp.%26nbsp%3B382&rft.edition=Second+edition&rft.place=Boca+Raton&rft.pub=CRC+Press%2C+Taylor+%26+Francis+Group%2C+CRC+Press+is+an+imprint+of+the+Taylor+%26+Francis+Group%2C+an+informa+business&rft.isbn=978-1-4987-4954-1&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3D3m4NDgAAQBAJ%26pg%3DPA382&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-:1-15\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-:1_15-0\">15.0<\/a><\/sup> <sup><a href=\"#cite_ref-:1_15-1\">15.1<\/a><\/sup> <sup><a href=\"#cite_ref-:1_15-2\">15.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Wang, Lawrence K.; Wang, Mu-Hao Sung; Hung, Yung-Tse, eds. (2022) (in en). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=JxaIEAAAQBAJ&pg=PA108\" target=\"_blank\"><i>Waste Treatment in the Biotechnology, Agricultural and Food Industries: Volume 1<\/i><\/a>. Handbook of Environmental Engineering. <b>26<\/b>. Cham: Springer International Publishing. pp. 108\u20139. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2F978-3-031-03591-3\" target=\"_blank\">10.1007\/978-3-031-03591-3<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-3-031-03589-0<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=JxaIEAAAQBAJ&pg=PA108\" target=\"_blank\">https:\/\/books.google.com\/books?id=JxaIEAAAQBAJ&pg=PA108<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Waste+Treatment+in+the+Biotechnology%2C+Agricultural+and+Food+Industries%3A+Volume+1&rft.date=2022&rft.series=Handbook+of+Environmental+Engineering&rft.volume=26&rft.pages=pp.%26nbsp%3B108%E2%80%939&rft.place=Cham&rft.pub=Springer+International+Publishing&rft_id=info:doi\/10.1007%2F978-3-031-03591-3&rft.isbn=978-3-031-03589-0&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DJxaIEAAAQBAJ%26pg%3DPA108&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-:2-16\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-:2_16-0\">16.0<\/a><\/sup> <sup><a href=\"#cite_ref-:2_16-1\">16.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Committee on Environment and Public Works (28 September 2000). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=dk-gi6ZZ_KsC&pg=PA1\" target=\"_blank\">\"Federal Formulated Fuels Act of 2000: Report of the Committee on Environment and Public Works, United States Senate\"<\/a>. U.S. Government Printing Office<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=dk-gi6ZZ_KsC&pg=PA1\" target=\"_blank\">https:\/\/books.google.com\/books?id=dk-gi6ZZ_KsC&pg=PA1<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Federal+Formulated+Fuels+Act+of+2000%3A+Report+of+the+Committee+on+Environment+and+Public+Works%2C+United+States+Senate&rft.atitle=&rft.aulast=Committee+on+Environment+and+Public+Works&rft.au=Committee+on+Environment+and+Public+Works&rft.date=28+September+2000&rft.pub=U.S.+Government+Printing+Office&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Ddk-gi6ZZ_KsC%26pg%3DPA1&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-:3-17\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-:3_17-0\">17.0<\/a><\/sup> <sup><a href=\"#cite_ref-:3_17-1\">17.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">World Health Organization (2022) (in en). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/apps.who.int\/iris\/handle\/10665\/355755\" target=\"_blank\"><i>Reformulation of food and beverage products for healthier diets: policy brief<\/i><\/a>. Geneva: World Health Organization. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-92-4-003991-9<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/apps.who.int\/iris\/handle\/10665\/355755\" target=\"_blank\">https:\/\/apps.who.int\/iris\/handle\/10665\/355755<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Reformulation+of+food+and+beverage+products+for+healthier+diets%3A+policy+brief&rft.aulast=World+Health+Organization&rft.au=World+Health+Organization&rft.date=2022&rft.place=Geneva&rft.pub=World+Health+Organization&rft.isbn=978-92-4-003991-9&rft_id=https%3A%2F%2Fapps.who.int%2Firis%2Fhandle%2F10665%2F355755&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-:4-18\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-:4_18-0\">18.0<\/a><\/sup> <sup><a href=\"#cite_ref-:4_18-1\">18.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Raikos, Vassilios; Ranawana, Viren, eds. (2019) (in en). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=zkG1DwAAQBAJ&pg=PA1\" target=\"_blank\"><i>Reformulation as a Strategy for Developing Healthier Food Products: Challenges, Recent Developments and Future Prospects<\/i><\/a>. Cham: Springer International Publishing. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2F978-3-030-23621-2\" target=\"_blank\">10.1007\/978-3-030-23621-2<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-3-030-23620-5<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=zkG1DwAAQBAJ&pg=PA1\" target=\"_blank\">https:\/\/books.google.com\/books?id=zkG1DwAAQBAJ&pg=PA1<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Reformulation+as+a+Strategy+for+Developing+Healthier+Food+Products%3A+Challenges%2C+Recent+Developments+and+Future+Prospects&rft.date=2019&rft.place=Cham&rft.pub=Springer+International+Publishing&rft_id=info:doi\/10.1007%2F978-3-030-23621-2&rft.isbn=978-3-030-23620-5&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DzkG1DwAAQBAJ%26pg%3DPA1&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-:5-19\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-:5_19-0\">19.0<\/a><\/sup> <sup><a href=\"#cite_ref-:5_19-1\">19.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Lechevalier, S\u00e9bastien, ed. (2019) (in en). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=Sx2nDwAAQBAJ&pg=PA133\" target=\"_blank\"><i>Innovation Beyond Technology: Science for Society and Interdisciplinary Approaches<\/i><\/a>. Creative Economy. Singapore: Springer Singapore. pp. 133\u20137. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2F978-981-13-9053-1\" target=\"_blank\">10.1007\/978-981-13-9053-1<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-981-13-9052-4<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=Sx2nDwAAQBAJ&pg=PA133\" target=\"_blank\">https:\/\/books.google.com\/books?id=Sx2nDwAAQBAJ&pg=PA133<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Innovation+Beyond+Technology%3A+Science+for+Society+and+Interdisciplinary+Approaches&rft.date=2019&rft.series=Creative+Economy&rft.pages=pp.%26nbsp%3B133%E2%80%937&rft.place=Singapore&rft.pub=Springer+Singapore&rft_id=info:doi\/10.1007%2F978-981-13-9053-1&rft.isbn=978-981-13-9052-4&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DSx2nDwAAQBAJ%26pg%3DPA133&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-:7-20\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-:7_20-0\">20.0<\/a><\/sup> <sup><a href=\"#cite_ref-:7_20-1\">20.1<\/a><\/sup> <sup><a href=\"#cite_ref-:7_20-2\">20.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Raj, B.; Jayakumar, T.; Thavasimuthu, M. (2014). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/archive.org\/details\/practicalnondest0000rajb\" target=\"_blank\"><i>Practical Non-Destructive Testing<\/i><\/a> (Ninth Reprint, 3rd ed.). Narosa Publishing House Pvt. Ltd. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9788173197970<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/archive.org\/details\/practicalnondest0000rajb\" target=\"_blank\">https:\/\/archive.org\/details\/practicalnondest0000rajb<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Practical+Non-Destructive+Testing&rft.aulast=Raj%2C+B.%3B+Jayakumar%2C+T.%3B+Thavasimuthu%2C+M.&rft.au=Raj%2C+B.%3B+Jayakumar%2C+T.%3B+Thavasimuthu%2C+M.&rft.date=2014&rft.edition=Ninth+Reprint%2C+3rd&rft.pub=Narosa+Publishing+House+Pvt.+Ltd&rft.isbn=9788173197970&rft_id=https%3A%2F%2Farchive.org%2Fdetails%2Fpracticalnondest0000rajb&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-21\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Huang, Songling; Wang, Shen (2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=YuCvCwAAQBAJ&printsec=frontcover\" target=\"_blank\">\"Chapter 1: The Electromagnetic Ultrasonic Guided Wave Testing\"<\/a> (in en). <i>New Technologies in Electromagnetic Non-destructive Testing<\/i>. Springer Series in Measurement Science and Technology. Singapore: Springer Singapore. pp. 1. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2F978-981-10-0578-7\" target=\"_blank\">10.1007\/978-981-10-0578-7<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-981-10-0577-0<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=YuCvCwAAQBAJ&printsec=frontcover\" target=\"_blank\">https:\/\/books.google.com\/books?id=YuCvCwAAQBAJ&printsec=frontcover<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+1%3A+The+Electromagnetic+Ultrasonic+Guided+Wave+Testing&rft.atitle=New+Technologies+in+Electromagnetic+Non-destructive+Testing&rft.aulast=Huang&rft.aufirst=Songling&rft.au=Huang%2C%26%2332%3BSongling&rft.au=Wang%2C%26%2332%3BShen&rft.date=2016&rft.series=Springer+Series+in+Measurement+Science+and+Technology&rft.pages=pp.%26nbsp%3B1&rft.place=Singapore&rft.pub=Springer+Singapore&rft_id=info:doi\/10.1007%2F978-981-10-0578-7&rft.isbn=978-981-10-0577-0&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DYuCvCwAAQBAJ%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-22\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Tian, Guiyun; Gao, Bin, eds. (29 September 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=by4NEAAAQBAJ&printsec=frontcover\" target=\"_blank\"><i>Electromagnetic Non-Destructive Evaluation (XXIII)<\/i><\/a>. Studies in Applied Electromagnetics and Mechanics. <b>45<\/b>. IOS Press. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.3233%2Fsaem45\" target=\"_blank\">10.3233\/saem45<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-1-64368-118-4<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=by4NEAAAQBAJ&printsec=frontcover\" target=\"_blank\">https:\/\/books.google.com\/books?id=by4NEAAAQBAJ&printsec=frontcover<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Electromagnetic+Non-Destructive+Evaluation+%28XXIII%29&rft.date=29+September+2020&rft.series=Studies+in+Applied+Electromagnetics+and+Mechanics&rft.volume=45&rft.pub=IOS+Press&rft_id=info:doi\/10.3233%2Fsaem45&rft.isbn=978-1-64368-118-4&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Dby4NEAAAQBAJ%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-23\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-23\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Jha, Shyam N., ed. (2010) (in en). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=RXIJu3TRPWEC&printsec=frontcover\" target=\"_blank\"><i>Nondestructive Evaluation of Food Quality: Theory and Practice<\/i><\/a>. Berlin, Heidelberg: Springer Berlin Heidelberg. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2F978-3-642-15796-7\" target=\"_blank\">10.1007\/978-3-642-15796-7<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-3-642-15795-0<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=RXIJu3TRPWEC&printsec=frontcover\" target=\"_blank\">https:\/\/books.google.com\/books?id=RXIJu3TRPWEC&printsec=frontcover<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Nondestructive+Evaluation+of+Food+Quality%3A+Theory+and+Practice&rft.date=2010&rft.place=Berlin%2C+Heidelberg&rft.pub=Springer+Berlin+Heidelberg&rft_id=info:doi\/10.1007%2F978-3-642-15796-7&rft.isbn=978-3-642-15795-0&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DRXIJu3TRPWEC%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-24\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-24\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Huebschen, Gerhard, ed. (2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=ZR1rBgAAQBAJ&printsec=frontcover\" target=\"_blank\"><i>Materials characterization using nondestructive evaluation (NDE) methods<\/i><\/a>. Woodhead Publishing series in electronic and optical materials. Amsterdam ; Boston: Elsevier\/Woodhead Publishing. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-08-100040-3. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Online_Computer_Library_Center\" data-key=\"b53206e2204c7e657858a88b56c8ac4a\">OCLC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/oclc\/932174125\" target=\"_blank\">932174125<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=ZR1rBgAAQBAJ&printsec=frontcover\" target=\"_blank\">https:\/\/books.google.com\/books?id=ZR1rBgAAQBAJ&printsec=frontcover<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Materials+characterization+using+nondestructive+evaluation+%28NDE%29+methods&rft.date=2016&rft.series=Woodhead+Publishing+series+in+electronic+and+optical+materials&rft.place=Amsterdam+%3B+Boston&rft.pub=Elsevier%2FWoodhead+Publishing&rft.isbn=978-0-08-100040-3&rft_id=info:oclcnum\/932174125&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DZR1rBgAAQBAJ%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SubramaniamTheStab16-25\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-SubramaniamTheStab16_25-0\">25.0<\/a><\/sup> <sup><a href=\"#cite_ref-SubramaniamTheStab16_25-1\">25.1<\/a><\/sup> <sup><a href=\"#cite_ref-SubramaniamTheStab16_25-2\">25.2<\/a><\/sup> <sup><a href=\"#cite_ref-SubramaniamTheStab16_25-3\">25.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Subramaniam, Persis, ed. (2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/956922925\" target=\"_blank\"><i>The stability and shelf life of food<\/i><\/a>. Woodhead Publishing Series in Food Science, Technology and Nutrition (Second edition ed.). Amsterdam: Elsevier\/WP, Woodhead Publishing. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-08-100436-4. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Online_Computer_Library_Center\" data-key=\"b53206e2204c7e657858a88b56c8ac4a\">OCLC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/oclc\/956922925\" target=\"_blank\">956922925<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/956922925\" target=\"_blank\">https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/956922925<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=The+stability+and+shelf+life+of+food&rft.date=2016&rft.series=Woodhead+Publishing+Series+in+Food+Science%2C+Technology+and+Nutrition&rft.edition=Second+edition&rft.place=Amsterdam&rft.pub=Elsevier%2FWP%2C+Woodhead+Publishing&rft.isbn=978-0-08-100436-4&rft_id=info:oclcnum\/956922925&rft_id=https%3A%2F%2Fwww.worldcat.org%2Ftitle%2Fmediawiki%2Foclc%2F956922925&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-26\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-26\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Komitopoulou, E. (2011). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/838321011\" target=\"_blank\">\"Microbiological challenge testing of food\"<\/a>. In Kilcast, David; Subramaniam, Persis. <i>Food and beverage stability and shelf life<\/i>. Woodhead Publishing Series in Food Science, Technology and Nutrition. Oxford: WP, Woodhead Publ. pp. 507\u2013526. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-85709-254-0. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Online_Computer_Library_Center\" data-key=\"b53206e2204c7e657858a88b56c8ac4a\">OCLC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/oclc\/838321011\" target=\"_blank\">838321011<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/838321011\" target=\"_blank\">https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/838321011<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Microbiological+challenge+testing+of+food&rft.atitle=Food+and+beverage+stability+and+shelf+life&rft.aulast=Komitopoulou%2C+E.&rft.au=Komitopoulou%2C+E.&rft.date=2011&rft.series=Woodhead+Publishing+Series+in+Food+Science%2C+Technology+and+Nutrition&rft.pages=pp.%26nbsp%3B507%E2%80%93526&rft.place=Oxford&rft.pub=WP%2C+Woodhead+Publ&rft.isbn=978-0-85709-254-0&rft_id=info:oclcnum\/838321011&rft_id=https%3A%2F%2Fwww.worldcat.org%2Ftitle%2Fmediawiki%2Foclc%2F838321011&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-:6-27\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-:6_27-0\">27.0<\/a><\/sup> <sup><a href=\"#cite_ref-:6_27-1\">27.1<\/a><\/sup> <sup><a href=\"#cite_ref-:6_27-2\">27.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Chen, S.-C. (2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=LyVhDwAAQBAJ&pg=PA264&dq=Stability,+cycle,+and+challenge+testing\" target=\"_blank\">\"Chapter 12: Container Closure Integrity Testing of Primary Containers for Parenteral Products\"<\/a>. In Warne, Nicholas W.; Mahler, Hanns-Christian (in en). <i>Challenges in Protein Product Development<\/i>. AAPS Advances in the Pharmaceutical Sciences Series. <b>38<\/b>. Cham: Springer International Publishing. pp. 257\u2013290. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2F978-3-319-90603-4\" target=\"_blank\">10.1007\/978-3-319-90603-4<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-3-319-90601-0<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=LyVhDwAAQBAJ&pg=PA264&dq=Stability,+cycle,+and+challenge+testing\" target=\"_blank\">https:\/\/books.google.com\/books?id=LyVhDwAAQBAJ&pg=PA264&dq=Stability,+cycle,+and+challenge+testing<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+12%3A+Container+Closure+Integrity+Testing+of+Primary+Containers+for+Parenteral+Products&rft.atitle=Challenges+in+Protein+Product+Development&rft.aulast=Chen%2C+S.-C.&rft.au=Chen%2C+S.-C.&rft.date=2018&rft.series=AAPS+Advances+in+the+Pharmaceutical+Sciences+Series&rft.volume=38&rft.pages=pp.%26nbsp%3B257%E2%80%93290&rft.place=Cham&rft.pub=Springer+International+Publishing&rft_id=info:doi\/10.1007%2F978-3-319-90603-4&rft.isbn=978-3-319-90601-0&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DLyVhDwAAQBAJ%26pg%3DPA264%26dq%3DStability%2C%2Bcycle%2C%2Band%2Bchallenge%2Btesting&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-28\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-28\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Baughan, Joan Sylvain, ed. (2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/on1272898230\" target=\"_blank\"><i>Global Legislation for Food Contact Materials<\/i><\/a>. Woodhead Publishing Series in Food Science, Technology and Nutrition (Second edition ed.). Oxford: Woodhead Publishing. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-12-821181-6. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Online_Computer_Library_Center\" data-key=\"b53206e2204c7e657858a88b56c8ac4a\">OCLC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/oclc\/on1272898230\" target=\"_blank\">on1272898230<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/on1272898230\" target=\"_blank\">https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/on1272898230<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Global+Legislation+for+Food+Contact+Materials&rft.date=2021&rft.series=Woodhead+Publishing+Series+in+Food+Science%2C+Technology+and+Nutrition&rft.edition=Second+edition&rft.place=Oxford&rft.pub=Woodhead+Publishing&rft.isbn=978-0-12-821181-6&rft_id=info:oclcnum\/on1272898230&rft_id=https%3A%2F%2Fwww.worldcat.org%2Ftitle%2Fmediawiki%2Foclc%2Fon1272898230&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BaloghTesting11-29\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BaloghTesting11_29-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Balogh, M.P. (2011). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.chromatographyonline.com\/view\/testing-critical-interface-leachables-and-extractables\" target=\"_blank\">\"Testing the Critical Interface: Leachables and Extractables\"<\/a>. <i>LCGC North America<\/i> <b>29<\/b> (6): 492\u2013501<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.chromatographyonline.com\/view\/testing-critical-interface-leachables-and-extractables\" target=\"_blank\">https:\/\/www.chromatographyonline.com\/view\/testing-critical-interface-leachables-and-extractables<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Testing+the+Critical+Interface%3A+Leachables+and+Extractables&rft.jtitle=LCGC+North+America&rft.aulast=Balogh%2C+M.P.&rft.au=Balogh%2C+M.P.&rft.date=2011&rft.volume=29&rft.issue=6&rft.pages=492%E2%80%93501&rft_id=https%3A%2F%2Fwww.chromatographyonline.com%2Fview%2Ftesting-critical-interface-leachables-and-extractables&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LAExtract-30\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LAExtract_30-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/leeder-analytical.com\/extractables-and-leachables-testing\/\" target=\"_blank\">\"Extractables and leachables testing (E&Ls)\"<\/a>. Leeder Analytical<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/leeder-analytical.com\/extractables-and-leachables-testing\/\" target=\"_blank\">https:\/\/leeder-analytical.com\/extractables-and-leachables-testing\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Extractables+and+leachables+testing+%28E%26Ls%29&rft.atitle=&rft.pub=Leeder+Analytical&rft_id=https%3A%2F%2Fleeder-analytical.com%2Fextractables-and-leachables-testing%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BSNutTest-31\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BSNutTest_31-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bevsource.com\/news\/what-do-i-need-know-about-nutrition-testing-my-beverage-brand\" target=\"_blank\">\"What Do I Need To Know About Nutrition Testing for My Beverage Brand?\"<\/a>. BevSource. 5 May 2023<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.bevsource.com\/news\/what-do-i-need-know-about-nutrition-testing-my-beverage-brand\" target=\"_blank\">https:\/\/www.bevsource.com\/news\/what-do-i-need-know-about-nutrition-testing-my-beverage-brand<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=What+Do+I+Need+To+Know+About+Nutrition+Testing+for+My+Beverage+Brand%3F&rft.atitle=&rft.date=5+May+2023&rft.pub=BevSource&rft_id=https%3A%2F%2Fwww.bevsource.com%2Fnews%2Fwhat-do-i-need-know-about-nutrition-testing-my-beverage-brand&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CA80-2020-32\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CA80-2020_32-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B80-2020%252FCXC_080e.pdf\" target=\"_blank\">\"Code of Practice on Food Allergen Management for Food Business Operators, CXC 80-2020\"<\/a> (PDF). <i>Codex Alimentarius<\/i>. 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B80-2020%252FCXC_080e.pdf\" target=\"_blank\">https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B80-2020%252FCXC_080e.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Code+of+Practice+on+Food+Allergen+Management+for+Food+Business+Operators%2C+CXC+80-2020&rft.atitle=Codex+Alimentarius&rft.date=2020&rft_id=https%3A%2F%2Fwww.fao.org%2Ffao-who-codexalimentarius%2Fsh-proxy%2Fen%2F%3Flnk%3D1%26url%3Dhttps%25253A%25252F%25252Fworkspace.fao.org%25252Fsites%25252Fcodex%25252FStandards%25252FCXC%252B80-2020%25252FCXC_080e.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DanielPoka21-33\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DanielPoka21_33-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Daniel, D. (October 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.techtarget.com\/searcherp\/definition\/poka-yoke\" target=\"_blank\">\"poka-yoke\"<\/a>. <i>TechTarget ERP - Definition<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.techtarget.com\/searcherp\/definition\/poka-yoke\" target=\"_blank\">https:\/\/www.techtarget.com\/searcherp\/definition\/poka-yoke<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=poka-yoke&rft.atitle=TechTarget+ERP+-+Definition&rft.aulast=Daniel%2C+D.&rft.au=Daniel%2C+D.&rft.date=October+2021&rft_id=https%3A%2F%2Fwww.techtarget.com%2Fsearcherp%2Fdefinition%2Fpoka-yoke&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-34\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-34\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Dogan, O.; Cebeci, U. (2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/link.springer.com\/10.1007\/978-3-030-69314-5\" target=\"_blank\">\"Chapter 1: An Integrated Quality Tools Approach for New Product Development\"<\/a>. In Garc\u00eda Alcaraz, Jorge Luis; S\u00e1nchez-Ram\u00edrez, Cuauht\u00e9moc; Gil L\u00f3pez, Alfonso Jes\u00fas (in en). <i>Techniques, Tools and Methodologies Applied to Quality Assurance in Manufacturing<\/i>. Cham: Springer International Publishing. pp. 3\u201322. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2F978-3-030-69314-5\" target=\"_blank\">10.1007\/978-3-030-69314-5<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-3-030-69313-8<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/link.springer.com\/10.1007\/978-3-030-69314-5\" target=\"_blank\">https:\/\/link.springer.com\/10.1007\/978-3-030-69314-5<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+1%3A+An+Integrated+Quality+Tools+Approach+for+New+Product+Development&rft.atitle=Techniques%2C+Tools+and+Methodologies+Applied+to+Quality+Assurance+in+Manufacturing&rft.aulast=Dogan%2C+O.%3B+Cebeci%2C+U.&rft.au=Dogan%2C+O.%3B+Cebeci%2C+U.&rft.date=2021&rft.pages=pp.%26nbsp%3B3%E2%80%9322&rft.place=Cham&rft.pub=Springer+International+Publishing&rft_id=info:doi\/10.1007%2F978-3-030-69314-5&rft.isbn=978-3-030-69313-8&rft_id=https%3A%2F%2Flink.springer.com%2F10.1007%2F978-3-030-69314-5&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BaukhPreprod20-35\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BaukhPreprod20_35-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Baukh, O. (14 October 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/techpacker.com\/blog\/manufacturing\/pre-production-processes-in-garment-manufacturing\/\" target=\"_blank\">\"Pre-production processes in garment manufacturing\"<\/a>. <i>Techpacker<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/techpacker.com\/blog\/manufacturing\/pre-production-processes-in-garment-manufacturing\/\" target=\"_blank\">https:\/\/techpacker.com\/blog\/manufacturing\/pre-production-processes-in-garment-manufacturing\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Pre-production+processes+in+garment+manufacturing&rft.atitle=Techpacker&rft.aulast=Baukh%2C+O.&rft.au=Baukh%2C+O.&rft.date=14+October+2020&rft_id=https%3A%2F%2Ftechpacker.com%2Fblog%2Fmanufacturing%2Fpre-production-processes-in-garment-manufacturing%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-EPAFiling22-36\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EPAFiling22_36-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/filing-pre-manufacture-notice-epa\" target=\"_blank\">\"Filing a Pre-manufacture Notice with EPA\"<\/a>. <i>Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)<\/i>. U.S. Environmental Protection Agency. 26 October 2022<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/filing-pre-manufacture-notice-epa\" target=\"_blank\">https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/filing-pre-manufacture-notice-epa<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Filing+a+Pre-manufacture+Notice+with+EPA&rft.atitle=Reviewing+New+Chemicals+under+the+Toxic+Substances+Control+Act+%28TSCA%29&rft.date=26+October+2022&rft.pub=U.S.+Environmental+Protection+Agency&rft_id=https%3A%2F%2Fwww.epa.gov%2Freviewing-new-chemicals-under-toxic-substances-control-act-tsca%2Ffiling-pre-manufacture-notice-epa&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AnjoranBasic10-37\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AnjoranBasic10_37-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Anjoran, R. (February 2010). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/qualityinspection.org\/quality-control-basics\/\" target=\"_blank\">\"Basic Quality Control Concepts\"<\/a>. <i>QualityInspection.org<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/qualityinspection.org\/quality-control-basics\/\" target=\"_blank\">https:\/\/qualityinspection.org\/quality-control-basics\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Basic+Quality+Control+Concepts&rft.atitle=QualityInspection.org&rft.aulast=Anjoran%2C+R.&rft.au=Anjoran%2C+R.&rft.date=February+2010&rft_id=https%3A%2F%2Fqualityinspection.org%2Fquality-control-basics%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MalsamQual22-38\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MalsamQual22_38-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Malsam, W. (6 December 2022). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.projectmanager.com\/blog\/quality-control-manufacturing\" target=\"_blank\">\"Quality Control in Manufacturing: A Quick Guide\"<\/a>. <i>ProectManager.com<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.projectmanager.com\/blog\/quality-control-manufacturing\" target=\"_blank\">https:\/\/www.projectmanager.com\/blog\/quality-control-manufacturing<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Quality+Control+in+Manufacturing%3A+A+Quick+Guide&rft.atitle=ProectManager.com&rft.aulast=Malsam%2C+W.&rft.au=Malsam%2C+W.&rft.date=6+December+2022&rft_id=https%3A%2F%2Fwww.projectmanager.com%2Fblog%2Fquality-control-manufacturing&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-39\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-39\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Seo, K.H.; Brackett, R.E. (1 January 2005). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0362028X22009000\" target=\"_blank\">\"Rapid, Specific Detection of Enterobacter sakazakii in Infant Formula Using a Real-Time PCR Assay\"<\/a> (in en). <i>Journal of Food Protection<\/i> <b>68<\/b> (1): 59\u201363. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.4315%2F0362-028X-68.1.59\" target=\"_blank\">10.4315\/0362-028X-68.1.59<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0362028X22009000\" target=\"_blank\">https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0362028X22009000<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Rapid%2C+Specific+Detection+of+Enterobacter+sakazakii+in+Infant+Formula+Using+a+Real-Time+PCR+Assay&rft.jtitle=Journal+of+Food+Protection&rft.aulast=Seo&rft.aufirst=K.H.&rft.au=Seo%2C%26%2332%3BK.H.&rft.au=Brackett%2C%26%2332%3BR.E.&rft.date=1+January+2005&rft.volume=68&rft.issue=1&rft.pages=59%E2%80%9363&rft_id=info:doi\/10.4315%2F0362-028X-68.1.59&rft_id=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS0362028X22009000&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RichardsonControl18-40\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RichardsonControl18_40-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Richardson, M. (30 August 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aero-mag.com\/controlling-product-quality-with-hardness-testing\" target=\"_blank\">\"Controlling product quality with hardness testing\"<\/a>. <i>Aerospace Manufacturing<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.aero-mag.com\/controlling-product-quality-with-hardness-testing\" target=\"_blank\">https:\/\/www.aero-mag.com\/controlling-product-quality-with-hardness-testing<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Controlling+product+quality+with+hardness+testing&rft.atitle=Aerospace+Manufacturing&rft.aulast=Richardson%2C+M.&rft.au=Richardson%2C+M.&rft.date=30+August+2018&rft_id=https%3A%2F%2Fwww.aero-mag.com%2Fcontrolling-product-quality-with-hardness-testing&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-41\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-41\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Downey, Gerard (2016) (in English). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=Q-8QCgAAQBAJ&printsec=frontcover\" target=\"_blank\"><i>Advances in Food Authenticity Testing.<\/i><\/a>. S.l.: Woodhead Publishing.. pp. 798. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-08-100233-9. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Online_Computer_Library_Center\" data-key=\"b53206e2204c7e657858a88b56c8ac4a\">OCLC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/oclc\/1096681184\" target=\"_blank\">1096681184<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=Q-8QCgAAQBAJ&printsec=frontcover\" target=\"_blank\">https:\/\/books.google.com\/books?id=Q-8QCgAAQBAJ&printsec=frontcover<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Advances+in+Food+Authenticity+Testing.&rft.aulast=Downey&rft.aufirst=Gerard&rft.au=Downey%2C%26%2332%3BGerard&rft.date=2016&rft.pages=pp.%26nbsp%3B798&rft.place=S.l.&rft.pub=Woodhead+Publishing.&rft.isbn=978-0-08-100233-9&rft_id=info:oclcnum\/1096681184&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DQ-8QCgAAQBAJ%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-42\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-42\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Tan, Choon Hui; Kong, Ianne; Irfan, Umair; Solihin, Mahmud Iwan; Pui, Liew Phing (2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jstage.jst.go.jp\/article\/jos\/70\/10\/70_ess21109\/_article\" target=\"_blank\">\"Edible Oils Adulteration: A Review on Regulatory Compliance and Its Detection Technologies\"<\/a> (in en). <i>Journal of Oleo Science<\/i> <b>70<\/b> (10): 1343\u20131356. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.5650%2Fjos.ess21109\" target=\"_blank\">10.5650\/jos.ess21109<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" data-key=\"a5dec3e4d005e654c29ad167ab53f53a\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/issn\/1345-8957\" target=\"_blank\">1345-8957<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.jstage.jst.go.jp\/article\/jos\/70\/10\/70_ess21109\/_article\" target=\"_blank\">https:\/\/www.jstage.jst.go.jp\/article\/jos\/70\/10\/70_ess21109\/_article<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Edible+Oils+Adulteration%3A+A+Review+on+Regulatory+Compliance+and+Its+Detection+Technologies&rft.jtitle=Journal+of+Oleo+Science&rft.aulast=Tan&rft.aufirst=Choon+Hui&rft.au=Tan%2C%26%2332%3BChoon+Hui&rft.au=Kong%2C%26%2332%3BIanne&rft.au=Irfan%2C%26%2332%3BUmair&rft.au=Solihin%2C%26%2332%3BMahmud+Iwan&rft.au=Pui%2C%26%2332%3BLiew+Phing&rft.date=2021&rft.volume=70&rft.issue=10&rft.pages=1343%E2%80%931356&rft_id=info:doi\/10.5650%2Fjos.ess21109&rft.issn=1345-8957&rft_id=https%3A%2F%2Fwww.jstage.jst.go.jp%2Farticle%2Fjos%2F70%2F10%2F70_ess21109%2F_article&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-43\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-43\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">U.S. Consumer Product Safety Commission (2023). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cpsc.gov\/Business--Manufacturing\/Business-Education\/Toy-Safety-Business-Guidance-and-Small-Entity-Compliance-Guide\" target=\"_blank\">\"Toy Safety Business Guidance & Small Entity Compliance Guide\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cpsc.gov\/Business--Manufacturing\/Business-Education\/Toy-Safety-Business-Guidance-and-Small-Entity-Compliance-Guide\" target=\"_blank\">https:\/\/www.cpsc.gov\/Business--Manufacturing\/Business-Education\/Toy-Safety-Business-Guidance-and-Small-Entity-Compliance-Guide<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Toy+Safety+Business+Guidance+%26+Small+Entity+Compliance+Guide&rft.atitle=&rft.aulast=U.S.+Consumer+Product+Safety+Commission&rft.au=U.S.+Consumer+Product+Safety+Commission&rft.date=2023&rft_id=https%3A%2F%2Fwww.cpsc.gov%2FBusiness--Manufacturing%2FBusiness-Education%2FToy-Safety-Business-Guidance-and-Small-Entity-Compliance-Guide&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DouglasFDA22-44\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DouglasFDA22_44-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Douglas, S. (21 February 2022). <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:FDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods:_Considerations_for_Labs_and_Informatics_Vendors\" data-key=\"db3a91773a3d971ad1c5d4df3a7cfd32\">\"FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors\"<\/a>. <i>LIMSwiki.org<\/i><span class=\"printonly\">. <a rel=\"nofollow\" class=\"external free wiki-link\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:FDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods:_Considerations_for_Labs_and_Informatics_Vendors\" data-key=\"db3a91773a3d971ad1c5d4df3a7cfd32\">https:\/\/www.limswiki.org\/index.php\/LII:FDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods:_Considerations_for_Labs_and_Informatics_Vendors<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=FDA+Food+Safety+Modernization+Act+Final+Rule+on+Laboratory+Accreditation+for+Analyses+of+Foods%3A+Considerations+for+Labs+and+Informatics+Vendors&rft.atitle=LIMSwiki.org&rft.aulast=Douglas%2C+S.&rft.au=Douglas%2C+S.&rft.date=21+February+2022&rft_id=https%3A%2F%2Fwww.limswiki.org%2Findex.php%2FLII%3AFDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods%3A_Considerations_for_Labs_and_Informatics_Vendors&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-45\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-45\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">U.S. Consumer Product Safety Commission (2023). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cpsc.gov\/Business--Manufacturing\/Testing-Certification\/Lab-Accreditation\" target=\"_blank\">\"Third-Party Testing Laboratory Accreditation & Small Entity Compliance Guide\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cpsc.gov\/Business--Manufacturing\/Testing-Certification\/Lab-Accreditation\" target=\"_blank\">https:\/\/www.cpsc.gov\/Business--Manufacturing\/Testing-Certification\/Lab-Accreditation<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Third-Party+Testing+Laboratory+Accreditation+%26+Small+Entity+Compliance+Guide&rft.atitle=&rft.aulast=U.S.+Consumer+Product+Safety+Commission&rft.au=U.S.+Consumer+Product+Safety+Commission&rft.date=2023&rft_id=https%3A%2F%2Fwww.cpsc.gov%2FBusiness--Manufacturing%2FTesting-Certification%2FLab-Accreditation&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HoSanit20-46\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HoSanit20_46-0\">46.0<\/a><\/sup> <sup><a href=\"#cite_ref-HoSanit20_46-1\">46.1<\/a><\/sup> <sup><a href=\"#cite_ref-HoSanit20_46-2\">46.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation\" id=\"rdp-ebb-CITEREFHoSandoval2020\">Ho, Kai-Lai Grace; Sandoval, Alex (2020), Demirci, Ali; Feng, Hao; Krishnamurthy, Kathiravan, eds., <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/link.springer.com\/10.1007\/978-3-030-42660-6_7\" target=\"_blank\">\"Sanitation Standard Operating Procedures (SSOPs)\"<\/a> (in en), <i>Food Safety Engineering<\/i> (Cham: Springer International Publishing): 175\u2013190, <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2F978-3-030-42660-6_7\" target=\"_blank\">10.1007\/978-3-030-42660-6_7<\/a>, <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-3-030-42659-0<span class=\"printonly\">, <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/link.springer.com\/10.1007\/978-3-030-42660-6_7\" target=\"_blank\">http:\/\/link.springer.com\/10.1007\/978-3-030-42660-6_7<\/a><\/span><\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Sanitation+Standard+Operating+Procedures+%28SSOPs%29&rft.jtitle=Food+Safety+Engineering&rft.aulast=Ho&rft.aufirst=Kai-Lai+Grace&rft.au=Ho%2C%26%2332%3BKai-Lai+Grace&rft.au=Sandoval%2C%26%2332%3BAlex&rft.date=2020&rft.pages=175%E2%80%93190&rft.place=Cham&rft.pub=Springer+International+Publishing&rft_id=info:doi\/10.1007%2F978-3-030-42660-6_7&rft.isbn=978-3-030-42659-0&rft_id=http%3A%2F%2Flink.springer.com%2F10.1007%2F978-3-030-42660-6_7&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-47\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-47\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation\" id=\"rdp-ebb-CITEREFSchmidtPiotter2020\">Schmidt, Ronald H.; Piotter, Helen M. (2020), Demirci, Ali; Feng, Hao; Krishnamurthy, Kathiravan, eds., <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/link.springer.com\/10.1007\/978-3-030-42660-6_12\" target=\"_blank\">\"The Hygienic\/Sanitary Design of Food and Beverage Processing Equipment\"<\/a> (in en), <i>Food Safety Engineering<\/i> (Cham: Springer International Publishing): 267\u2013332, <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2F978-3-030-42660-6_12\" target=\"_blank\">10.1007\/978-3-030-42660-6_12<\/a>, <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-3-030-42659-0<span class=\"printonly\">, <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/link.springer.com\/10.1007\/978-3-030-42660-6_12\" target=\"_blank\">http:\/\/link.springer.com\/10.1007\/978-3-030-42660-6_12<\/a><\/span><\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Hygienic%2FSanitary+Design+of+Food+and+Beverage+Processing+Equipment&rft.jtitle=Food+Safety+Engineering&rft.aulast=Schmidt&rft.aufirst=Ronald+H.&rft.au=Schmidt%2C%26%2332%3BRonald+H.&rft.au=Piotter%2C%26%2332%3BHelen+M.&rft.date=2020&rft.pages=267%E2%80%93332&rft.place=Cham&rft.pub=Springer+International+Publishing&rft_id=info:doi\/10.1007%2F978-3-030-42660-6_12&rft.isbn=978-3-030-42659-0&rft_id=http%3A%2F%2Flink.springer.com%2F10.1007%2F978-3-030-42660-6_12&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-EUSelect20-48\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-EUSelect20_48-0\">48.0<\/a><\/sup> <sup><a href=\"#cite_ref-EUSelect20_48-1\">48.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">n.a. (3 April 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/engineering-update.co.uk\/2020\/04\/03\/selecting-materials-for-standard-parts-in-the-food-and-beverage-industry-a-buyers-guide\/\" target=\"_blank\">\"Selecting materials for standard parts in the food and beverage industry: a buyers\u2019 guide\"<\/a>. <i>Engineering Update<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/engineering-update.co.uk\/2020\/04\/03\/selecting-materials-for-standard-parts-in-the-food-and-beverage-industry-a-buyers-guide\/\" target=\"_blank\">https:\/\/engineering-update.co.uk\/2020\/04\/03\/selecting-materials-for-standard-parts-in-the-food-and-beverage-industry-a-buyers-guide\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Selecting+materials+for+standard+parts+in+the+food+and+beverage+industry%3A+a+buyers%E2%80%99+guide&rft.atitle=Engineering+Update&rft.aulast=n.a.&rft.au=n.a.&rft.date=3+April+2020&rft_id=https%3A%2F%2Fengineering-update.co.uk%2F2020%2F04%2F03%2Fselecting-materials-for-standard-parts-in-the-food-and-beverage-industry-a-buyers-guide%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ATSWhy20-49\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ATSWhy20_49-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.advancedtech.com\/blog\/why-manufacturers-should-care-about-calibration\/\" target=\"_blank\">\"Why Manufacturers Should Care About Calibration\"<\/a>. Advanced Technology Services, Inc. 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.advancedtech.com\/blog\/why-manufacturers-should-care-about-calibration\/\" target=\"_blank\">https:\/\/www.advancedtech.com\/blog\/why-manufacturers-should-care-about-calibration\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Why+Manufacturers+Should+Care+About+Calibration&rft.atitle=&rft.date=2020&rft.pub=Advanced+Technology+Services%2C+Inc&rft_id=https%3A%2F%2Fwww.advancedtech.com%2Fblog%2Fwhy-manufacturers-should-care-about-calibration%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230516214942\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.615 seconds\nReal time usage: 0.639 seconds\nPreprocessor visited node count: 38336\/1000000\nPost\u2010expand include size: 337697\/2097152 bytes\nTemplate argument size: 106720\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 99305\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 590.355 1 -total\n 91.85% 542.251 1 Template:Reflist\n 72.51% 428.064 49 Template:Citation\/core\n 35.71% 210.808 24 Template:Cite_book\n 30.77% 181.676 19 Template:Cite_web\n 11.63% 68.639 41 Template:Date\n 8.12% 47.940 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\n 7.59% 44.796 3 Template:Citation\n 6.64% 39.200 3 Template:Cite_journal\n 5.22% 30.831 46 Template:Citation\/identifier\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14173-0!canonical and timestamp 20230516214942 and revision id 51994. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","f5c58bc41bd3b4f5fc4356c7aea9ef5c_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/4\/46\/Food_Safety_Lab_%28Gibson_-_52032197020.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/0\/0f\/Infrared_spectrometer_for_screening_for_food_adulteration%2C_in_CAFIA_laboratory%2C_Czech_Republic.png"],"f5c58bc41bd3b4f5fc4356c7aea9ef5c_timestamp":1684275142,"96de3aa20642fa1b28c2f9ea79116b43_type":"article","96de3aa20642fa1b28c2f9ea79116b43_title":"1.1 Manufacturing labs, then and now","96de3aa20642fa1b28c2f9ea79116b43_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now","96de3aa20642fa1b28c2f9ea79116b43_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Introduction to manufacturing laboratories\/Manufacturing labs, then and nowFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 1. Introduction to manufacturing laboratories \n\n1.1 1.1 Manufacturing labs, then and now \n\n1.1.1 1.1.1 From apothecary to small-scale manufacturing laboratory \n1.1.2 1.1.2 From small-scale private manufacturing lab to larger-scale industrial manufacturing lab \n1.1.3 1.1.3 The rise of the industrial research lab within large-scale manufacturing, and today's manufacturing landscape \n\n\n\n\n2 References \n\n\n\n1. Introduction to manufacturing laboratories \nAccording to McKinsey & Company, the U.S. manufacturing industry represents only 11 percent of U.S. gross domestic product (GDP) and eight percent of direct employment, yet it \"makes a disproportionate economic contribution, including 20 percent of the nation\u2019s capital investment, 35 percent of productivity growth, 60 percent of exports, and 70 percent of business R&D spending.\"[1] These categories of economic contribution are important as many of them indirectly point to how the work of laboratories is interwoven within the manufacturing industry. As we'll discuss later in this chapter, manufacturing-based laboratories primarily serve three roles: research and development (R&D), pre-manufacturing and manufacturing, and post-production regulation and security (e.g., through exports and trade). We can be sure that if U.S. manufacturers' efforts represent huge chunks of total business R&D spending, trade, and capital expenditure (capex), a non-trivial amount of laboratory effort is associated with that spending. Why? Because R&D, trade, and manufacturing quality control (QC) activities rarely can occur without laboratories backing up their work.[2][3][4][5]\nLabs in the manufacturing sector provide vital services, including but not limited to quality assurance (QA), QC, production control, regulatory trade control (e.g., authenticity and adulteration), safety management, label claim testing, and packaging analysis. These activities occur in a wide array of manufacturing industries. Looking to the North American Industry Classification System (NAICS), employed by the U.S. Bureau of Labor Statistics (BLS), manufacturing industries and sub-industries include[6]:\n\napparel (e.g., knitted goods, cut-and-sew clothing, buttons and clasps)\nchemical (e.g., pesticides, fertilizers, paints, cleaning products, adhesives, electroplating solutions)\nelectric power (e.g., light bulbs, household appliances, energy storage cells, transformers)\nelectronics (e.g., sensors, semiconductors, electrodes, mobile phones, computers)\nfood and beverage (e.g., baked goods, probiotics, preservatives, wine)\nfurniture (e.g., mattresses, sofas, window blinds, light fixtures)\nleather (e.g., purses, saddles, footwear, bookbinding hides)\nmachinery (e.g., mining augers, air conditioning units, turbines, lathes)\nmaterials (e.g., ceramics, cements, glass, nanomaterials)\nmedical equipment and supplies (e.g., ventilators, implants, lab equipment, prosthetics, surgical equipment)\nmetal forming and casting (e.g., steel beams, aluminum ingots, shipping containers, hand tools, wire)\npaper and printing (e.g., cardboard, sanitary items, stationery, books, bookbinding papers)\npetrochemical (e.g., solvents, fuel additives, biofuels, lubricants)\npharmaceutical and medicine (e.g., antivenom, vaccines, lab-on-a-chip diagnostic tests, cannabis products, nutraceuticals)\nplastics and rubbers (e.g., dinnerware, tires, storage and shelving, outdoor furniture)\ntextiles (e.g., carpeting, upholstery, bulk fabric, yarn)\nvehicular and aerospace (e.g., electric vehicles, reusable rocketry, railroad rolling stock, OEM auto parts)\nwood (e.g., plywood, flooring, lumber, handrails)\nIf you've ever used a sophisticated two-part epoxy adhesive to repair a pipe crack, used an indoor sun lamp, gotten a lot of mileage out of a pair of leather gloves, received a medical implant, taken a medication, eaten a Twinkie, or ridden on Amtrak, one or more laboratories were involved somewhere in the manufacturing process before using that item. From endless research and testing of prototypes to various phases of quality and safety testing, laboratory science was involved. The importance of the laboratory in manufacturing processes can't be understated.\nBut what of the history of the manufacturing-focused lab? What of the roles played and testing conducted in them? What do they owe to safety and quality? This chapter more closely examines these questions and more.\n\r\n\n\n 1.1 Manufacturing labs, then and now \nIn 1852, the Putnam's Home Cyclopedia: Hand-Book of the Useful Arts was published as a dictionary-like source of scientific terms. Its definition of a laboratory at that time in U.S. history is revealing (for more on the equipment typically described with a laboratory of that time period, see the full definition)[7]:\n\nLaboratory. The workshop of a chemist. Some laboratories are intended for private research, and some for the manufacture of chemicals on the large scale. Hence it is almost impossible to give a description of the apparatus and disposition of a laboratory which would be generally true of all. A manufacturing laboratory necessarily occupies a large space, while that of the scientific man is necessarily limited to a peculiar line of research. Those who study in organic chemistry have different arrangements than that of the mineral analyst.\nThis definition highlights the state of laboratories at the time: typically you either had a small private laboratory for experiments in the name of research and development (R&D) and producing prototype solutions, or you had a slightly larger \"manufacturing laboratory\" that was responsible for the creation of chemicals, reagents, or other substances for a wider customer base.[7][8][9] These laboratory types date back further than the mid-1800s, to be sure, though they also saw great change leading up to and after this time period. This is best characterized by the transition from the humble apothecary lab to the small-scale manufacturing laboratory before the mid-1800s, to the full-scale pharmaceutical manufacturing lab and facility well beyond the mid-1800s.\n\n1.1.1 From apothecary to small-scale manufacturing laboratory \nA critical area to examine in relation to the evolution of manufacturing laboratories involves pharmaceuticals and the apothecary, which is steeped in the tradition of making pharmaceutical preparations, as well as prescribing and dispensing them to customers. The idea of an individual who attempted to make medical treatments dates back to at least 2000 BC, from which Sumerian documents reveal compounding formulas for various medicinal dosage types.[10] By 1540, Swiss physician and chemist Paracelsus made a significant contribution to the early apothecary, influencing \"the transformation of pharmacy from a profession based primarily on botanic science to one based on chemical science.\"[10] Thanks to Paracelsus and other sixteenth century practitioners, the concept of the apothecary became more formalized and chemistry-based in the early seventeenth century. With this formalization came the need for the regulation of apothecaries to better ensure the integrity of the profession. For example, the Master, Wardens and Society of the Art and Mystery of Pharmacopolites of the City of London was founded in 1617 through the Royal Charter of James the First, requiring an aspiring apothecary to conduct an apprenticeship or pay a fee, followed by taking an examination proving the individual's knowledge, skill, and science in the art.[10][11] \nHowever, despite this sort of early regulation, medical practitioners took exception to apothecaries encroaching upon the medical practitioners' own services, and apothecaries took exception to the untrained and uncertified druggists who were still performing the work of pharmacists. (As it turns out, these sorts of recriminations would continue on in some form or another into the beginning of the twenty-first century, discussed later.) But as an 1897 article from The Pharmaceutical Journal portrayed, the apothecaries likely wanted to have their cake and eat it too. \"[W]hile the apothecaries urged, in the interest of the public, the desirability of a guarantee for the the competences of every person authorised to practise pharmacy,\" the journal noted, \"they also sought, in their own interest, to extend the scope of their medical practice.\"[11] This led to further debate and changes over time, including British Parliament declaring medicinal preparations as \"very proper objects for taxation\" in 1783, while at the same time requiring non-apprenticed apothecaries to apply annually for a license. By this time, most apprenticed apothecaries ceased being perceived as mere pharmacists and more as medical practitioners, though the Society's power of conferring medical qualifications, given to them in 1617, were by this point largely lost.[11]\nBy the end of the eighteenth century, apothecaries and druggists were setting up their own manufacturing laboratories to make chemical and pharmaceutical products. However, these labs were likely still limited in scope. In 1897, The Pharmaceutical Journal portrayed manufacturing labs as such, in the scope of the growing Plough Court Pharmacy run by William Allen and Luke Howard[11]:\n\nIt is, however, difficult to at the present time to realise what must have been the position of a manufacturing chemist in 1797, or to comprehend, without some reflection, how limited was the range of his operations and how much his work was beset with difficulties which are now scarcely conceivable. At that time chemical industry was confined to the production of soap, the mineral acids, and some saline compounds then used in medicine. Among the latter, mercurial preparations held an important place, and some of these appear to have first received attention by the firm of Allen and Howard. The early laboratory account books of the firm mention ammoniacals, caustic potash, borax, argentic nitrate, and cream of tartar, as well as ether, benzoic acid, and refine camphor, which were then articles of the materia medics, citric, tartatic and oxalic acids, etc.\nTo be sure, other types of manufacturing were occurring during the rise and dominance of the apothecary, not just pharmaceutical manufacture. But, retrospectively, the pharmaceutical manufacturing lab in general was likely not in the best of shape as the nineteenth century approached. With several changes in Europe and United States in the early 1800s, the apothecary's manufacturing lab arguably saw more formalized and regulated activity, through various releases of pharmacopoeias[10][12], openings of new pharmacy schools (though still limited in scope)[13], publishing of books[13], and additional formalization of regulating legislation (such as Britain's Apothecaries Act of 1815).[11] By the time the United States Pharmacopeia came upon the scene in 1820, the apothecary was viewed as \"competent at collecting and identifying botanic drugs and preparing from them the mixtures and preparations required by the physician.\"[10] Pharmaceutical historian Loyd Allen, Jr. refers to this time period as \"a time that would never be seen again,\" a sort of Golden Age of the apothecary, given the increasingly rapid rate that scientific and technological discoveries were being made soon after, particularly in synthetic organic chemistry.[10]\nOf course, the manufacturing lab\u2014pharmaceutical and otherwise\u2014had other issues as well. For example, just because a small-scale experimental R&D process yielded a positive result didn't mean that process was scalable to large-scale manufacturing. \"Frequently, things work well on a small scale, and failure results when mass action comes into effect,\" noted Armour Fertilizer Company's president Charles McDowell in April 1917, while discussing American research methods.[14] Sometimes a process was sufficiently simple that switching to more robust and appropriate apparatuses was all that was needed to scale up from experiment to full production.[15] In other cases, a full-scale manufacturing laboratory process had yet to be developed, let alone the experiments conducted to develop a proof-of-concept solution in the experimental lab.[16]\nAnother challenge the manufacturing lab had was in ensuring the stability of any laboratory manufactured solution. Discussing the British Pharmacopoeia-introduced substance of sulphurous acid for afflictions of the throat, Fellow of the Chemical Society Charles Umney noted the stability considerations of the substance when made in the manufacturing laboratory[17]:\n\nNow the Pharmacopoeia solution (which is about 37 volumes) was designedly made nearly one of saturation at the average summer temperature of this country, and, if one may be excused for making a guess, we described from calculations made from the above data of Bunsen's, and not practically worked out to see whether such a solution could be ordinarily obtained in the manufacturing laboratory without chance of failure, and, when made, be kept without great alteration in the various stages it would have to pass through, even if only from the manufacturer to the wholesale druggist, then to the pharmacists, in whose store it might retain for a year or more, being perhaps placed in a temperature many degrees above the point at which it was saturated, thereby causing expansion, liberation of gas, and inconvenience.\nDifficulties aside, as the 1800s progressed, the resources of a collaboratory manufacturing laboratory were often greater than those of the individual private laboratory, with enterprising businesses increasingly turning to larger labs for greater and more high-quality quantities of materials. For example, in a letter from the Royal Institution of Great Britain, editor William Crookes discussed the discovery of thallium, noting that the manufacturing lab of noted manufacturing chemists Hopkin and Williams were able to prepare chloride of thallium for him from two hundredweight (cwt) in less time than it took Crookes to make 10 pounds of sulfur in his private laboratory.[18] This trend would continue into the late 1800s, for pharmaceutical and other manufactured goods.\n\n1.1.2 From small-scale private manufacturing lab to larger-scale industrial manufacturing lab \nBy the 1860s, numerous changes to the paradigm of the manufacturing lab were beginning to take shape, with noticeable momentum away from the small-scale private manufacturing labs to those larger in scope and output, putting competitive pressures on the smaller manufacturing labs.[19] Take, for example, one of the largest U.S.-based enameled brick factories for its time, in 1896, which \"[i]n addition to their manufacturing laboratory for slips, enamels and glazes, they maintain an analytical chemical laboratory, and have two chemists in their employ.\"[20] Ten years prior, a report on the visit to the experimental and manufacturing laboratories of Louis Pasteur highlights the need for a more sizeable facility for meeting demand for the anthrax vaccine[21]:\nTo meet the demands upon the laboratory work for the supply of anthrax vaccine, the preparation of this is now carried out in an establishment apart from the experimental laboratory in connection with the Ecole Normale, where it was originally started. In the Rue Vaquelin, under the charge of educated assistants, M. Chamberland carries out the preparation on a large scale\u2014the necessity for this being apparent when regard is had to the statement of the quantity demanded for France and other countries.\nThe author, William Robertson, then goes into greater detail of the many rooms and floors of the building housing the manufacturing laboratory and its apparatuses, highlighting the grandness of the lab's efforts.\nThe change from small-scale private to larger-scale industrial manufacturing labs\u2014in turn seemingly being supplanted by analytical laboratories[22]\u2014is arguably best seen in the transition from the apothecary and pharmacist to the large-scale pharmaceutical manufacturer. During this time of change in the late 1800s, laws dictating higher manufacturing quality, educational requirements, and restrictions on who can sell medicines were derided, debated, or cheered, depending on who was involved.[23][24]\nReading for a meeting at the Kings County Pharmaceutical Society of Ohio, Charles E. Parker had the following to say about the state of the apothecary-turned-pharmacist in 1896, which fully highlights the transition from small-scale private to larger-scale industrial manufacturing of pharmaceuticals[24]:\n\nThe modern pharmacist succeeds to all the responsibilities and obligations of the ancient apothecary without opposition, but his utmost efforts have not preserved to him his inheritance of former privileges and emoluments ... Technical skill is of no use to the professional side of pharmacy unless it is used, and used for the public welfare as well as that of its possessor. The dispenser is the typical pharmacist. But where in former years his sphere included many activities and much manipulative expertness in the preparation of drugs, and even the production of many of them, the modern tendency is for him to become a mere compounder and dispenser. Of course he is expected to know how, but actually is seldom required to perform the operations once a matter of constant routine. Step by step the productive processes of his little laboratory have been transferred to the works of large manufacturers. Year by year the pharmaceutical improvements and useful inventions which would once have conferred reputation and profit upon the dispensing pharmacies where they originated, have found a better market through these same manufacturers ... In addition, it is to be considered that some of the requisites of modern pharmacy are of a nature involving the use of expensive machinery and large plant, which places their production quite beyond the reach of the pharmacy.\nWriting for the Pharmaceutical Review in 1897, editor Dr. Edward Kremers penned an editorial on the role of the manufacturing laboratory in the growing pharmaceutical industry, noting that \"[d]uring the past hundred years a most remarkable industrial revolution has taken place,\" and that pharmacy was also victim to that, lamenting that the apothecaries of the beginning of the century\u2014along with the druggists of 1897\u2014had largely become \"relics of the past.\"[25] Kremers also touched upon another complaint popular at the time: that of pharmacy as a money-making venture.[22][25] In his editorial, Kremers said:\n\nIt is a hope cherished by some that higher education will revolutionize pharmacy of today and lift her out of her present unenviable situation. The manufacturing industries, however, have revolutionized pharmacy of fifty years ago and are to no small extent coresponsible for the present state of affairs. The pharmaceutical profession as a whole is justified in asking what a particular branch is doing for the general good. Is the pharmaceutical manufacturer in the erection of his buildings, in the equipment of his laboratories and in the selection of his working force simply bent upon making so many thousands of dollars a paying investment, viewed from a merely commercial standpoint, or are his doings influenced to some extent to at least by higher than purely necessary motives.\nBy the early years of 1900, recognition of the sea-level change to the apothecary, pharmacist, and manufacturing laboratory had arguably gained traction, and by 1920 it was largely accepted[26]. Writing for The Rocky Mountain Druggist in 1908, pharmaceutical doctor Geo H. Meeker laid it out in no uncertain terms: \n\nLarge manufacturing establishments can, for the most part, furnish the druggist at lower prices, with better authentic goods than he himself could produce, assay and guarantee. The inevitable result is that the druggist of today purchases finished products rather than raw materials as did the apothecary of yesterday. It is obvious that a large manufacturing establishment, conducted on ethical lines, employing a complete corps of specialists, buying raw materials to the best advantage and by assay only, making preparations on a large and intelligent technical scale and testing and assaying the finished products, does a work that is too immense in its scope for the individual apothecary ... Our present remnant of the drug store laboratory is, as in the past, essentially a manufacturing laboratory. It is of limited and rapidly vanishing scope because the small local laboratory man cannot successfully compete with his rivals, the great and highly-organized factories.\nSimilar comments were being made by Pearson in 1911[19], Thiesing in 1915[27], and Beal in 1919.[26] Beal in particular spoke solemnly of the transition, largely complete by the time of his acceptance of the Joseph P. Remington Honor Medal in 1919. Speaking of Remington and his experiences in pharmacy, until his death in 1918, Beal said[26]:\n\nProfessor Remington's professional experience bridged the space between two distinct periods of pharmaceutical development. When he began his apprenticeship the apothecary, as he was then commonly called, was the principal manufacturer as well as the purveyor of medical supplies ... He lived to see the period when the apothecary ceased to be the principal producer of medicinal compounds and became mainly the purveyor of preparations manufactured by others, and when the medicinal agents in most common use assumed a character that required for the successful production the resources of establishments maintained by large aggregations of capital and employing large numbers of specially trained workers.\r\n \r\nTo those who knew him intimately it was evident that although Professor Remington did not welcome the passing of the manufacturing functions of the apothecary to the large laboratory, he at length came to realize that such a change was inevitable, that it was but a natural step in the process of social evolution, and that the logical action of the apothecary was not to resist that which he could neither prevent nor change, but to readjust himself to the new conditions.\nOf course, by then, the rise of the industrial research lab within large-scale manufacturing enterprises was in full swing.\n\n 1.1.3 The rise of the industrial research lab within large-scale manufacturing, and today's manufacturing landscape \nLike the small, privately owned manufacturing labs evolving to large-scale company-run manufacturing labs, so did the research processes of prior days. The individual tinkering with research in their private laboratory and making small batches of product gave way to a collective of individuals with more specialized talents cooperatively working in a large industrial manufacturing center towards a common, often complex research goal, i.e., within the industrial research laboratory.[28][29] Those larger manufacturing entities that didn't have an industrial research lab were beginning to assess the value of adding one, while smaller enterprises that didn't have the resources to support an extensive collection of manufacturing and research labs were increasingly joining forces \"to maintain laboratories doing work for the whole industry.\"[28] \nBut what drove the advance of the industrial research lab? As the National Research Council pointed out in 1940, \"individuals working independently could not, for very long, provide the technical and scientific knowledge essential to a rapidly developing industrial nation.\"[30] Newly emerging industries had a need for new knowledge to feed their growth, and they proved to be the early adopters of establishing separate research departments or divisions in their businesses, unlike businesses in long-established industries. The First World War was also responsible for driving organized research efforts in various industries to solve not only wartime problems but also plant the seed of development in peacetime industries. By 1920, two-thirds of all research workers surveyed by the National Research Council were employed in the emerging electrical, chemical, and rubber industries, though the overall adoption of industrial research approaches was still limited across all companies.[30] \nIn 1917, the previously mentioned Charles McDowell presented his view of American research and manufacturing methods of his time, referring to research as \"diligent inquiry.\"[14] In his work, McDowell stated three types of research that leads up to the manufacturing process: pure scientific inquiry, industrial research, and factory research. He noted that of pure scientific inquiry, little thought is typically given to whether the research\u2014often conducted by university professors\u2014will have any real commercial value, though such value is able to emerge from this fundamental research. As for factory research, McDowell characterized it as full-scale factory-level operations that range from haphazard approaches to well-calculated contingency planning, all of which could make or break the manufacturing business.\nIn regards to the middle category of industrial research, McDowell made several observations that aptly described the state of manufacturing research in the early 1900s. He noted that unlike pure scientific inquiry, industrial research had commercial practicality as a goal, often beginning with small-scale experiments while later seeking how to reproduce those theoretical results into large-scale manufacturing. He also reiterated his point about needing to \"have good backing\" financially. \"The larger manufacturer maintains his own staff and equipment to carry out investigations along any line that may seem desirable,\" he said, \"but the smaller industries are not able to support an establishment and must rely on either consulting engineers or turn their problems over to some equipped public or private laboratory to solve.\"[14] \nIn his 1920 book The Organization of Industrial Scientific Research, Mees presented these three types of research somewhat similarly, though in the context of the industrial laboratory and its operations. Mees argued that industrial laboratories could be classified into three divisions[28]:\n\nLaboratories \"working on pure theory and the fundamental sciences associated with the industry,\" aligning in part with McDowell's \"pure scientific inquiry\";\nWork laboratories \"exerting analytical control over materials, processes and product,\" aligning slightly with McDowell's \"factory research\" but more akin to the modern quality control lab; and\nIndustrial laboratories \"working on improvements in product and in processes,\" aligning with McDowell's \"industrial research.\"\nMees argued in particular that those industrial research laboratories that simply improve products and processes were not doing enough; they should, necessarily, also direct some of their goals towards more fully understanding the fundamental and underlying theory of the topic of research.[28] In other words, Mees suggested that those labs simply working on theoretical and fundamental science research, as well as those labs conducting industrial research to improve products and processes, shouldn't necessarily function in separate vacuums. \"Research work of this fundamental kind involves a laboratory very different from the usual works laboratory and also investigators of a different type from those employed in a purely industrial laboratory,\" he noted. Of course, this hybrid approach to fundamental and industrial research was largely reserved for the largest of manufacturers, and solutions were needed for smaller manufacturing endeavors. Here, like McDowell in 1917, Mees argued for smaller businesses with limited resources to adopt both cooperative laboratory (those businesses that pool resources together for a fully supported research laboratory) and consulting laboratory (a third-party lab with the resources to fully study a problem, undertake investigations, model a manufacturing process, and implement that process into its client's factory, all for a fee) approaches.[28] With such solutions, the industrial research laboratory continued to take on a new level of complexity to address emerging industry needs, far from the humble origins of an early nineteenth-century manufacturing laboratory.\nThis growth or industrial research would continue onward from the twentieth century into the twenty-first century. In 1921, some 15 companies maintained research groups of more than 50 people; by 1938, there were 120 such businesses.[30] By the 1990s, \"the share of funding for basic research provided by industry actually grew from 10 percent to 25 percent of the national total, even though basic research accounted for just 5-7 percent of total R&D expenditures by industry.\"[31] This trend of large research groups continues today, though with the recognition that smaller teams may still have advantages. In a 2019 article in the Harvard Business Review, Wang and Evans recognize \"large teams as optimal engines for tomorrow\u2019s largest advances,\" while smaller research teams are better poised to ask disruptive questions and make innovative discoveries.[32]\n\nReferences \n\n\n\u2191 Carr, T.; Chewning, E.; Doheny, M. et al. (29 August 2022). \"Delivering the US manufacturing renaissance\". McKinsey & Company. https:\/\/www.mckinsey.com\/capabilities\/operations\/our-insights\/delivering-the-us-manufacturing-renaissance . Retrieved 05 May 2023 .   \n \n\n\u2191 Ischi, H. P.; Radvila, P. R. (17 January 1997). \"Accreditation and quality assurance in Swiss chemical laboratories\". Accreditation and Quality Assurance 2 (1): 36\u201339. doi:10.1007\/s007690050092. ISSN 0949-1775. http:\/\/link.springer.com\/10.1007\/s007690050092 .   \n \n\n\u2191 Crow, Michael M.; Bozeman, Barry (1998). \"Chapter 1: The Sixteen Thousand: Policy Analysis, R&D Laboratories, and the National Innovation System\". Limited by design: R&D laboratories in the U.S. national innovation system. New York: Columbia University Press. pp. 1\u201340. ISBN 978-0-585-04137-7. https:\/\/books.google.com\/books?hl=en&lr=&id=OVPZvqz2e6UC .   \n \n\n\u2191 Grochau, In\u00eas Hexsel; ten Caten, Carla Schwengber (1 October 2012). \"A process approach to ISO\/IEC 17025 in the implementation of a quality management system in testing laboratories\" (in en). Accreditation and Quality Assurance 17 (5): 519\u2013527. doi:10.1007\/s00769-012-0905-3. ISSN 0949-1775. http:\/\/link.springer.com\/10.1007\/s00769-012-0905-3 .   \n \n\n\u2191 Ribeiro, \u00c0.S.; Gust, J.; Vilhena, A. et al. (2019). \"The role of laboratories in the international development of accreditation\". Proceedings of the 16th IMEKO TC10 Conference \"Testing, Diagnostics & Inspection as a comprehensive value chain for Quality & Safety\": 56\u20139. https:\/\/www.imeko.info\/index.php\/proceedings\/7687-the-role-of-laboratories-in-the-international-development-of-accreditation .   \n \n\n\u2191 \"Manufacturing: NAICS 31-33\". Industries at a Glance. U.S. Bureau of Labor Statistics. 5 May 2023. https:\/\/www.bls.gov\/iag\/tgs\/iag31-33.htm . Retrieved 05 May 2023 .   \n \n\n\u2191 7.0 7.1 Antisell, T. (1852). Putnam's Home Cyclopedia: Hand-Book of the Useful Arts. 3. George P. Putnam. pp. 284-5. https:\/\/books.google.com\/books?id=vsI0AAAAMAAJ&pg=PA284 . Retrieved 31 March 2023 .   \n \n\n\u2191 Porter, A.L. (1830). \"Chemistry Applied to the Arts\". The Chemistry of the Arts; being a Practical Display of the Arts and Manufactures which Depend on Chemical Principles. Carey & Lea. pp. 17\u201318. https:\/\/books.google.com\/books?id=zy8aAAAAYAAJ&pg=PA17&dq=manufacturing+laboratory . Retrieved 05 May 2023 . \"The larger laboratories, or workshops, which are used only in particular branches of business, and the necessary apparatus attached to them, will be considered under the several substances which are prepared in them. Besides the workshop, every operative chemist ought to devote some part of his premises as a small general elaboratory, fitted up with some furnaces and other apparatus as may enable him to make any experiment seemingly applicable to the improvement of his manufacturing process without loss of time, and immediately upon its inception.\"   \n \n\n\u2191 Marsh, G. P. (1846). Speech of Mr. Marsh, of Vermont, on the Hill for Establishing the Smithsonian Institution, Delivered in The House of Representatives of the U. States, April 22, 1846. J. & G.S. Gideon. p. 11. https:\/\/books.google.com\/books?id=ptg-AAAAYAAJ&pg=PA11&dq=manufacturing+laboratory . Retrieved 05 May 2023 . \"How are new substances formed, or the stock of a given substance increased, by the chemistry of nature or of art? By new combinations or decompositions of known and pre-existing elements. The products of the experimental or manufacturing laboratory are no new creations; but their elements are first extracted by the decomposition of old components, and then recombined in new forms.\"   \n \n\n\u2191 10.0 10.1 10.2 10.3 10.4 10.5 Allen Jr., L.V. (2011). \"A History of Pharmaceutical Compounding\" (PDF). Secundum Artem 11 (3). Archived from the original on 28 January 2013. https:\/\/web.archive.org\/web\/20130128014521\/https:\/\/www.perrigo.com\/business\/pdfs\/Sec%20Artem%2011.3.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 11.0 11.1 11.2 11.3 11.4 \"The Plough Court Pharmacy\". The Pharmaceutical Journal (Pharmaceutical Society of Great Britain) LVIII: 164\u20137, 247\u201351. January to June 1897. https:\/\/www.google.com\/books\/edition\/Pharmaceutical_Journal\/ScDyXwC8McwC?hl=en&gbpv=1&dq=manufacturing+laboratory&pg=PA164&printsec=frontcover . Retrieved 05 May 2023 .   \n \n\n\u2191 Anderson, S.C. (2013). \"Pharmacopoeias of Great Britain\" (PDF). A History of the Pharmacopoeias of the World. International Society for the History of Pharmacy. pp. 1\u20138. http:\/\/www.histpharm.org\/ISHPWG%20UK.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 13.0 13.1 \"The Early Days of Pharmaceutical\". The Druggists Circular LXII (6): 244\u20135. June 1918. https:\/\/books.google.com\/books?id=P3kgAQAAMAAJ&pg=RA2-PA243-IA1&dq=manufacturing+laboratory . Retrieved 05 May 2023 .   \n \n\n\u2191 14.0 14.1 14.2 McDowell, C.A. (1917). \"American Research Methods\". Journal of the Western Society of Engineers XXII (8): 546\u201365. https:\/\/books.google.com\/books?id=8pMPAQAAIAAJ&pg=PA546&dq=manufacturing+laboratory . Retrieved 05 May 2023 .   \n \n\n\u2191 Robertson, J.C., ed. (1 July 1843). \"Desulphuration of Metals\". Mechanics' Magazine, Museum, Register, Journal, and Gazette 38: 444. https:\/\/books.google.com\/books?id=3u01AQAAMAAJ&pg=RA1-PA444&dq=manufacturing+laboratory . Retrieved 05 May 2023 .   \n \n\n\u2191 Jackson, C.T. (31 May 1843). \"Chemical Salts as Fertilizers\". New England Farmer, and Horticultural Register (Joseph Breck & Co) XXL (48): 379. https:\/\/books.google.com\/books?id=hrYxAQAAMAAJ&pg=PA379&dq=manufacturing+laboratory . Retrieved 05 May 2023 .   \n \n\n\u2191 Umney, C. (1869). \"Sulphurous Acid\". Pharmaceutical Journal and Transactions (John Churchill and Sons) X (IX): 516\u201320. https:\/\/books.google.com\/books?id=POkKAAAAYAAJ&pg=PA516&dq=manufacturing+laboratory . Retrieved 05 May 2023 .   \n \n\n\u2191 Crookes, W. (April 1863). \"On the Discovery of the Metal Thallium\". The Chemical News and Journal of Physical Chemistry VII (175): 172\u20136. https:\/\/books.google.com\/books?id=0JHOIc5pHYwC&pg=PA172&dq=manufacturing+laboratory . Retrieved 05 May 2023 .   \n \n\n\u2191 19.0 19.1 Pearson, W.A. (April 1911). \"The Preparation and Testing of Drugs\". The Journal of the Franklin Institute of the State of Pennsylvania CLXXI (4): 415\u201321. https:\/\/books.google.com\/books?id=GyFFAQAAMAAJ&pg=PA415&dq=manufacturing+laboratory . Retrieved 05 May 2023 . \"All the large drug laboratories have been developed since 1860 ... The increase in number of manufacturing laboratories and the consequent increase in competition exerted an influence on the wholesale druggist.\"   \n \n\n\u2191 Lockington, W.P. (April 1896). \"Enamled Brick at Oaks, PA\". The Clay-Worker XXV (4): 350\u201351. https:\/\/books.google.com\/books?id=lj9PAQAAIAAJ&pg=RA1-PA350&dq=manufacturing+laboratory . Retrieved 07 April 2023 .   \n \n\n\u2191 Robertson, W. (1886). \"Report of Visit to the Laboratories of M. Pasteur at Paris\". The Veterinary Journal and Annals of Comparative Pathology XXIII: 223\u20137. https:\/\/books.google.com\/books?id=a-AfAQAAIAAJ&pg=PA223&dq=manufacturing+laboratory . Retrieved 07 April 2023 .   \n \n\n\u2191 22.0 22.1 The Western Druggist (July 1902). \"Drug Clerks and Labor Unions\". The Western Druggist XXIV (7): 405. https:\/\/books.google.com\/books?id=qG8gAQAAMAAJ&pg=PA405&dq=manufacturing+laboratory . Retrieved 05 May 2023 .   \n \n\n\u2191 Lilly, J.K. (January 1883). \"The Relation of Manufacturing Pharmacists to Pharmacy Laws\". The Pharmacist and Chemist XVI (1): 258\u20139. https:\/\/books.google.com\/books?id=VlyFy6zJQpUC&pg=RA2-PA258&dq=manufacturing+laboratory . Retrieved 05 May 2023 .   \n \n\n\u2191 24.0 24.1 Parker, C.E. (25 March 1896). \"Some Aspects of Technical Pharmacy\". American Druggist and Pharmaceutical Record XXVIII (6): 183\u20134. https:\/\/books.google.com\/books?id=bSnnAAAAMAAJ&pg=PA183&dq=manufacturing+laboratory . Retrieved 05 May 2023 .   \n \n\n\u2191 25.0 25.1 Kremers, E. (April 1897). \"The Manufacturing Laboratory in the Household of Pharmacy\". Pharmaceutical Review 15 (4): 61\u20137. https:\/\/books.google.com\/books?id=4BU4AQAAMAAJ&pg=PA61&dq=manufacturing+laboratory . Retrieved 05 May 2023 .   \n \n\n\u2191 26.0 26.1 26.2 Diner, J.; Beal, J.H. (December 1919). \"Award of the Joseph B. Remington Honor Medal\". The Midland Druggist and Pharmaceutical Review LIII (12): 475\u20139. https:\/\/books.google.com\/books?id=GQlOAAAAMAAJ&pg=PA475&dq=manufacturing+laboratory . Retrieved 05 May 2023 .   \n \n\n\u2191 Thiesing, E.H. (October 1915). \"Proceedings of the Joint Session of the Commercial Section and Section on Education and Legislation - Chairman Thiesing's Address\". The Journal of the Americam Pharmaceutical Association IV (10). https:\/\/books.google.com\/books?id=b_5EAQAAMAAJ&pg=PA1203&dq=manufacturing+laboratory . Retrieved 05 May 2023 .   \n \n\n\u2191 28.0 28.1 28.2 28.3 28.4 Mees, C.E.K. (1920). \"Chapter 1: Introduction\". The Organization of Industrial Scientific Research. McGraw-Hill Book Company, Inc. pp. 4\u201310. https:\/\/books.google.com\/books?id=rDIuAAAAYAAJ&printsec=frontcover&dq=industrial+research+laboratories . Retrieved 05 May 2023 .   \n \n\n\u2191 Boyd, T.A. (May 1938). \"Putting Research to Work\". A.E.C. Bulletin - Invention and The Engineer's Relation to It (American Engineering Council): 22\u20139. https:\/\/books.google.com\/books?id=lYkiAQAAMAAJ&pg=RA23-PA22&dq=industrial+research+laboratories . Retrieved 05 May 2023 .   \n \n\n\u2191 30.0 30.1 30.2 National Research Council (December 1940). Research\u2014A National Resource, II\u2014Industrial Research. United States Government Printing Office. https:\/\/nap.nationalacademies.org\/read\/20233\/chapter\/4#34 . Retrieved 05 May 2023 .   \n \n\n\u2191 Usselman, S.W. (11 November 2013). \"Research and Development in the United States since 1900: An Interpretive History\". Yale University. https:\/\/economics.yale.edu\/sites\/default\/files\/usselman_paper.pdf . Retrieved 05 May 2023 .   \n \n\n\u2191 \"Research: When Small Teams Are Better Than Big Ones\". Harvard Business Review. 21 February 2019. https:\/\/hbr.org\/2019\/02\/research-when-small-teams-are-better-than-big-ones . Retrieved 05 May 2023 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 21:48.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 7 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","96de3aa20642fa1b28c2f9ea79116b43_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Introduction_to_manufacturing_laboratories_Manufacturing_labs_then_and_now rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Introduction_to_manufacturing_laboratories_Manufacturing_labs_then_and_now skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction to manufacturing laboratories\/Manufacturing labs, then and now<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h2><span class=\"mw-headline\" id=\"1._Introduction_to_manufacturing_laboratories\">1. Introduction to manufacturing laboratories<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:ParagonLab.jpg\" class=\"image wiki-link\" data-key=\"32cf4305bd129c39de0943170dc6c13d\"><img alt=\"ParagonLab.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/b8\/ParagonLab.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>According to McKinsey & Company, the U.S. manufacturing industry represents only 11 percent of U.S. gross domestic product (GDP) and eight percent of direct employment, yet it \"makes a disproportionate economic contribution, including 20 percent of the nation\u2019s capital investment, 35 percent of productivity growth, 60 percent of exports, and 70 percent of business R&D spending.\"<sup id=\"rdp-ebb-cite_ref-CarrDeliver22_1-0\" class=\"reference\"><a href=\"#cite_note-CarrDeliver22-1\">[1]<\/a><\/sup> These categories of economic contribution are important as many of them indirectly point to how the work of <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratories<\/a> is interwoven within the manufacturing industry. As we'll discuss later in this chapter, manufacturing-based laboratories primarily serve three roles: research and development (R&D), pre-manufacturing and manufacturing, and post-production regulation and security (e.g., through exports and trade). We can be sure that if U.S. manufacturers' efforts represent huge chunks of total business R&D spending, trade, and capital expenditure (capex), a non-trivial amount of laboratory effort is associated with that spending. Why? Because R&D, trade, and manufacturing <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_control\" title=\"Quality control\" class=\"wiki-link\" data-key=\"1e0e0c2eb3e45aff02f5d61799821f0f\">quality control<\/a> (QC) activities rarely can occur without laboratories backing up their work.<sup id=\"rdp-ebb-cite_ref-2\" class=\"reference\"><a href=\"#cite_note-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-3\" class=\"reference\"><a href=\"#cite_note-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-4\" class=\"reference\"><a href=\"#cite_note-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-5\" class=\"reference\"><a href=\"#cite_note-5\">[5]<\/a><\/sup>\n<\/p><p>Labs in the manufacturing sector provide vital services, including but not limited to <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_assurance\" title=\"Quality assurance\" class=\"wiki-link\" data-key=\"2ede4490f0ea707b14456f44439c0984\">quality assurance<\/a> (QA), QC, production control, regulatory trade control (e.g., authenticity and adulteration), safety management, label claim testing, and packaging analysis. These activities occur in a wide array of manufacturing industries. Looking to the North American Industry Classification System (NAICS), employed by the U.S. Bureau of Labor Statistics (BLS), manufacturing industries and sub-industries include<sup id=\"rdp-ebb-cite_ref-BLSManufact23_6-0\" class=\"reference\"><a href=\"#cite_note-BLSManufact23-6\">[6]<\/a><\/sup>:\n<\/p>\n<ul><li>apparel (e.g., knitted goods, cut-and-sew clothing, buttons and clasps)<\/li>\n<li>chemical (e.g., pesticides, fertilizers, paints, cleaning products, adhesives, electroplating solutions)<\/li>\n<li>electric power (e.g., light bulbs, household appliances, energy storage cells, transformers)<\/li>\n<li>electronics (e.g., sensors, semiconductors, electrodes, mobile phones, computers)<\/li>\n<li>food and beverage (e.g., baked goods, probiotics, preservatives, wine)<\/li>\n<li>furniture (e.g., mattresses, sofas, window blinds, light fixtures)<\/li>\n<li>leather (e.g., purses, saddles, footwear, bookbinding hides)<\/li>\n<li>machinery (e.g., mining augers, air conditioning units, turbines, lathes)<\/li>\n<li>materials (e.g., ceramics, cements, glass, nanomaterials)<\/li>\n<li>medical equipment and supplies (e.g., ventilators, implants, lab equipment, prosthetics, surgical equipment)<\/li>\n<li>metal forming and casting (e.g., steel beams, aluminum ingots, shipping containers, hand tools, wire)<\/li>\n<li>paper and printing (e.g., cardboard, sanitary items, stationery, books, bookbinding papers)<\/li>\n<li>petrochemical (e.g., solvents, fuel additives, biofuels, lubricants)<\/li>\n<li>pharmaceutical and medicine (e.g., antivenom, vaccines, lab-on-a-chip diagnostic tests, cannabis products, nutraceuticals)<\/li>\n<li>plastics and rubbers (e.g., dinnerware, tires, storage and shelving, outdoor furniture)<\/li>\n<li>textiles (e.g., carpeting, upholstery, bulk fabric, yarn)<\/li>\n<li>vehicular and aerospace (e.g., electric vehicles, reusable rocketry, railroad rolling stock, OEM auto parts)<\/li>\n<li>wood (e.g., plywood, flooring, lumber, handrails)<\/li><\/ul>\n<p>If you've ever used a sophisticated two-part epoxy adhesive to repair a pipe crack, used an indoor sun lamp, gotten a lot of mileage out of a pair of leather gloves, received a medical implant, taken a medication, eaten a Twinkie, or ridden on Amtrak, one or more laboratories were involved somewhere in the manufacturing process before using that item. From endless research and testing of prototypes to various phases of quality and safety testing, laboratory science was involved. The importance of the laboratory in manufacturing processes can't be understated.\n<\/p><p>But what of the history of the manufacturing-focused lab? What of the roles played and testing conducted in them? What do they owe to safety and quality? This chapter more closely examines these questions and more.\n<\/p><p><br \/>\n<\/p>\n<h3><span id=\"rdp-ebb-1.1_Manufacturing_labs,_then_and_now\"><\/span><span class=\"mw-headline\" id=\"1.1_Manufacturing_labs.2C_then_and_now\">1.1 Manufacturing labs, then and now<\/span><\/h3>\n<p>In 1852, the <i>Putnam's Home Cyclopedia: Hand-Book of the Useful Arts<\/i> was published as a dictionary-like source of scientific terms. Its definition of a laboratory at that time in U.S. history is revealing (for more on the equipment typically described with a laboratory of that time period, see the full definition)<sup id=\"rdp-ebb-cite_ref-AntisellPutnamArts52_7-0\" class=\"reference\"><a href=\"#cite_note-AntisellPutnamArts52-7\">[7]<\/a><\/sup>:\n<\/p>\n<blockquote><p><b>Laboratory<\/b>. The workshop of a chemist. Some laboratories are intended for private research, and some for the manufacture of chemicals on the large scale. Hence it is almost impossible to give a description of the apparatus and disposition of a laboratory which would be generally true of all. A manufacturing laboratory necessarily occupies a large space, while that of the scientific man is necessarily limited to a peculiar line of research. Those who study in organic chemistry have different arrangements than that of the mineral analyst.<\/p><\/blockquote>\n<p>This definition highlights the state of laboratories at the time: typically you either had a small private laboratory for experiments in the name of research and development (R&D) and producing prototype solutions, or you had a slightly larger \"manufacturing laboratory\" that was responsible for the creation of chemicals, reagents, or other substances for a wider customer base.<sup id=\"rdp-ebb-cite_ref-AntisellPutnamArts52_7-1\" class=\"reference\"><a href=\"#cite_note-AntisellPutnamArts52-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PorterTheChem30_8-0\" class=\"reference\"><a href=\"#cite_note-PorterTheChem30-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MarshSpeech46_9-0\" class=\"reference\"><a href=\"#cite_note-MarshSpeech46-9\">[9]<\/a><\/sup> These laboratory types date back further than the mid-1800s, to be sure, though they also saw great change leading up to and after this time period. This is best characterized by the transition from the humble apothecary lab to the small-scale manufacturing laboratory before the mid-1800s, to the full-scale pharmaceutical manufacturing lab and facility well beyond the mid-1800s.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"1.1.1_From_apothecary_to_small-scale_manufacturing_laboratory\">1.1.1 From apothecary to small-scale manufacturing laboratory<\/span><\/h4>\n<p>A critical area to examine in relation to the evolution of manufacturing laboratories involves pharmaceuticals and the apothecary, which is steeped in the tradition of making pharmaceutical preparations, as well as prescribing and dispensing them to customers. The idea of an individual who attempted to make medical treatments dates back to at least 2000 BC, from which Sumerian documents reveal compounding formulas for various medicinal dosage types.<sup id=\"rdp-ebb-cite_ref-AllenAHist11_10-0\" class=\"reference\"><a href=\"#cite_note-AllenAHist11-10\">[10]<\/a><\/sup> By 1540, Swiss physician and chemist Paracelsus made a significant contribution to the early apothecary, influencing \"the transformation of pharmacy from a profession based primarily on botanic science to one based on chemical science.\"<sup id=\"rdp-ebb-cite_ref-AllenAHist11_10-1\" class=\"reference\"><a href=\"#cite_note-AllenAHist11-10\">[10]<\/a><\/sup> Thanks to Paracelsus and other sixteenth century practitioners, the concept of the apothecary became more formalized and chemistry-based in the early seventeenth century. With this formalization came the need for the regulation of apothecaries to better ensure the integrity of the profession. For example, the Master, Wardens and Society of the Art and Mystery of Pharmacopolites of the City of London was founded in 1617 through the Royal Charter of James the First, requiring an aspiring apothecary to conduct an apprenticeship or pay a fee, followed by taking an examination proving the individual's knowledge, skill, and science in the art.<sup id=\"rdp-ebb-cite_ref-AllenAHist11_10-2\" class=\"reference\"><a href=\"#cite_note-AllenAHist11-10\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Plough97_11-0\" class=\"reference\"><a href=\"#cite_note-Plough97-11\">[11]<\/a><\/sup> \n<\/p><p>However, despite this sort of early regulation, medical practitioners took exception to apothecaries encroaching upon the medical practitioners' own services, and apothecaries took exception to the untrained and uncertified druggists who were still performing the work of pharmacists. (As it turns out, these sorts of recriminations would continue on in some form or another into the beginning of the twenty-first century, discussed later.) But as an 1897 article from <i>The Pharmaceutical Journal<\/i> portrayed, the apothecaries likely wanted to have their cake and eat it too. \"[W]hile the apothecaries urged, in the interest of the public, the desirability of a guarantee for the the competences of every person authorised to practise pharmacy,\" the journal noted, \"they also sought, in their own interest, to extend the scope of their medical practice.\"<sup id=\"rdp-ebb-cite_ref-Plough97_11-1\" class=\"reference\"><a href=\"#cite_note-Plough97-11\">[11]<\/a><\/sup> This led to further debate and changes over time, including British Parliament declaring medicinal preparations as \"very proper objects for taxation\" in 1783, while at the same time requiring non-apprenticed apothecaries to apply annually for a license. By this time, most apprenticed apothecaries ceased being perceived as mere pharmacists and more as medical practitioners, though the Society's power of conferring medical qualifications, given to them in 1617, were by this point largely lost.<sup id=\"rdp-ebb-cite_ref-Plough97_11-2\" class=\"reference\"><a href=\"#cite_note-Plough97-11\">[11]<\/a><\/sup>\n<\/p><p>By the end of the eighteenth century, apothecaries and druggists were setting up their own manufacturing laboratories to make chemical and pharmaceutical products. However, these labs were likely still limited in scope. In 1897, <i>The Pharmaceutical Journal<\/i> portrayed manufacturing labs as such, in the scope of the growing Plough Court Pharmacy run by William Allen and Luke Howard<sup id=\"rdp-ebb-cite_ref-Plough97_11-3\" class=\"reference\"><a href=\"#cite_note-Plough97-11\">[11]<\/a><\/sup>:\n<\/p>\n<blockquote><p>It is, however, difficult to at the present time to realise what must have been the position of a manufacturing chemist in 1797, or to comprehend, without some reflection, how limited was the range of his operations and how much his work was beset with difficulties which are now scarcely conceivable. At that time chemical industry was confined to the production of soap, the mineral acids, and some saline compounds then used in medicine. Among the latter, mercurial preparations held an important place, and some of these appear to have first received attention by the firm of Allen and Howard. The early laboratory account books of the firm mention ammoniacals, caustic potash, borax, argentic nitrate, and cream of tartar, as well as ether, benzoic acid, and refine camphor, which were then articles of the materia medics, citric, tartatic and oxalic acids, etc.<\/p><\/blockquote>\n<p>To be sure, other types of manufacturing were occurring during the rise and dominance of the apothecary, not just pharmaceutical manufacture. But, retrospectively, the pharmaceutical manufacturing lab in general was likely not in the best of shape as the nineteenth century approached. With several changes in Europe and United States in the early 1800s, the apothecary's manufacturing lab arguably saw more formalized and regulated activity, through various releases of pharmacopoeias<sup id=\"rdp-ebb-cite_ref-AllenAHist11_10-3\" class=\"reference\"><a href=\"#cite_note-AllenAHist11-10\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AndersonPharm13_12-0\" class=\"reference\"><a href=\"#cite_note-AndersonPharm13-12\">[12]<\/a><\/sup>, openings of new pharmacy schools (though still limited in scope)<sup id=\"rdp-ebb-cite_ref-DCTheEarly18_13-0\" class=\"reference\"><a href=\"#cite_note-DCTheEarly18-13\">[13]<\/a><\/sup>, publishing of books<sup id=\"rdp-ebb-cite_ref-DCTheEarly18_13-1\" class=\"reference\"><a href=\"#cite_note-DCTheEarly18-13\">[13]<\/a><\/sup>, and additional formalization of regulating legislation (such as Britain's Apothecaries Act of 1815).<sup id=\"rdp-ebb-cite_ref-Plough97_11-4\" class=\"reference\"><a href=\"#cite_note-Plough97-11\">[11]<\/a><\/sup> By the time the <i>United States Pharmacopeia<\/i> came upon the scene in 1820, the apothecary was viewed as \"competent at collecting and identifying botanic drugs and preparing from them the mixtures and preparations required by the physician.\"<sup id=\"rdp-ebb-cite_ref-AllenAHist11_10-4\" class=\"reference\"><a href=\"#cite_note-AllenAHist11-10\">[10]<\/a><\/sup> Pharmaceutical historian Loyd Allen, Jr. refers to this time period as \"a time that would never be seen again,\" a sort of Golden Age of the apothecary, given the increasingly rapid rate that scientific and technological discoveries were being made soon after, particularly in synthetic organic chemistry.<sup id=\"rdp-ebb-cite_ref-AllenAHist11_10-5\" class=\"reference\"><a href=\"#cite_note-AllenAHist11-10\">[10]<\/a><\/sup>\n<\/p><p>Of course, the manufacturing lab\u2014pharmaceutical and otherwise\u2014had other issues as well. For example, just because a small-scale experimental R&D process yielded a positive result didn't mean that process was scalable to large-scale manufacturing. \"Frequently, things work well on a small scale, and failure results when mass action comes into effect,\" noted Armour Fertilizer Company's president Charles McDowell in April 1917, while discussing American research methods.<sup id=\"rdp-ebb-cite_ref-McDowellAmerican17_14-0\" class=\"reference\"><a href=\"#cite_note-McDowellAmerican17-14\">[14]<\/a><\/sup> Sometimes a process was sufficiently simple that switching to more robust and appropriate apparatuses was all that was needed to scale up from experiment to full production.<sup id=\"rdp-ebb-cite_ref-RobertsonDesulph43_15-0\" class=\"reference\"><a href=\"#cite_note-RobertsonDesulph43-15\">[15]<\/a><\/sup> In other cases, a full-scale manufacturing laboratory process had yet to be developed, let alone the experiments conducted to develop a proof-of-concept solution in the experimental lab.<sup id=\"rdp-ebb-cite_ref-JacksonChemical43_16-0\" class=\"reference\"><a href=\"#cite_note-JacksonChemical43-16\">[16]<\/a><\/sup>\n<\/p><p>Another challenge the manufacturing lab had was in ensuring the stability of any laboratory manufactured solution. Discussing the British Pharmacopoeia-introduced substance of sulphurous acid for afflictions of the throat, Fellow of the Chemical Society Charles Umney noted the stability considerations of the substance when made in the manufacturing laboratory<sup id=\"rdp-ebb-cite_ref-UmneySulphurous69_17-0\" class=\"reference\"><a href=\"#cite_note-UmneySulphurous69-17\">[17]<\/a><\/sup>:\n<\/p>\n<blockquote><p>Now the Pharmacopoeia solution (which is about 37 volumes) was designedly made nearly one of saturation at the average summer temperature of this country, and, if one may be excused for making a guess, we described from calculations made from the above data of Bunsen's, and not practically worked out to see whether such a solution could be ordinarily obtained in the manufacturing laboratory without chance of failure, and, when made, be kept without great alteration in the various stages it would have to pass through, even if only from the manufacturer to the wholesale druggist, then to the pharmacists, in whose store it might retain for a year or more, being perhaps placed in a temperature many degrees above the point at which it was saturated, thereby causing expansion, liberation of gas, and inconvenience.<\/p><\/blockquote>\n<p>Difficulties aside, as the 1800s progressed, the resources of a collaboratory manufacturing laboratory were often greater than those of the individual private laboratory, with enterprising businesses increasingly turning to larger labs for greater and more high-quality quantities of materials. For example, in a letter from the Royal Institution of Great Britain, editor William Crookes discussed the discovery of thallium, noting that the manufacturing lab of noted manufacturing chemists Hopkin and Williams were able to prepare chloride of thallium for him from two hundredweight (cwt) in less time than it took Crookes to make 10 pounds of sulfur in his private laboratory.<sup id=\"rdp-ebb-cite_ref-CrookesOnThe63_18-0\" class=\"reference\"><a href=\"#cite_note-CrookesOnThe63-18\">[18]<\/a><\/sup> This trend would continue into the late 1800s, for pharmaceutical and other manufactured goods.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"1.1.2_From_small-scale_private_manufacturing_lab_to_larger-scale_industrial_manufacturing_lab\">1.1.2 From small-scale private manufacturing lab to larger-scale industrial manufacturing lab<\/span><\/h4>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:From_1800_to_1900._The_wonderful_story_of_the_century;_its_progress_and_achievements_(1899)_(14778122434).jpg\" class=\"image wiki-link\" data-key=\"0781e08de48d541ee5afb0b98a8acc84\"><img alt=\"From 1800 to 1900. The wonderful story of the century; its progress and achievements (1899) (14778122434).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/7\/7c\/From_1800_to_1900._The_wonderful_story_of_the_century%3B_its_progress_and_achievements_%281899%29_%2814778122434%29.jpg\" decoding=\"async\" width=\"300\" height=\"375\" \/><\/a><\/div><p>By the 1860s, numerous changes to the paradigm of the manufacturing lab were beginning to take shape, with noticeable momentum away from the small-scale private manufacturing labs to those larger in scope and output, putting competitive pressures on the smaller manufacturing labs.<sup id=\"rdp-ebb-cite_ref-PearsonThePrep11_19-0\" class=\"reference\"><a href=\"#cite_note-PearsonThePrep11-19\">[19]<\/a><\/sup> Take, for example, one of the largest U.S.-based enameled brick factories for its time, in 1896, which \"[i]n addition to their manufacturing laboratory for slips, enamels and glazes, they maintain an analytical chemical laboratory, and have two chemists in their employ.\"<sup id=\"rdp-ebb-cite_ref-LockingtonEnamled96_20-0\" class=\"reference\"><a href=\"#cite_note-LockingtonEnamled96-20\">[20]<\/a><\/sup> Ten years prior, a report on the visit to the experimental and manufacturing laboratories of Louis Pasteur highlights the need for a more sizeable facility for meeting demand for the anthrax vaccine<sup id=\"rdp-ebb-cite_ref-RobertsonReport86_21-0\" class=\"reference\"><a href=\"#cite_note-RobertsonReport86-21\">[21]<\/a><\/sup>:\n<\/p><blockquote><p>To meet the demands upon the laboratory work for the supply of anthrax vaccine, the preparation of this is now carried out in an establishment apart from the experimental laboratory in connection with the Ecole Normale, where it was originally started. In the Rue Vaquelin, under the charge of educated assistants, M. Chamberland carries out the preparation on a large scale\u2014the necessity for this being apparent when regard is had to the statement of the quantity demanded for France and other countries.<\/p><\/blockquote>\n<p>The author, William Robertson, then goes into greater detail of the many rooms and floors of the building housing the manufacturing laboratory and its apparatuses, highlighting the grandness of the lab's efforts.\n<\/p><p>The change from small-scale private to larger-scale industrial manufacturing labs\u2014in turn seemingly being supplanted by analytical laboratories<sup id=\"rdp-ebb-cite_ref-TWDDrugClerks02_22-0\" class=\"reference\"><a href=\"#cite_note-TWDDrugClerks02-22\">[22]<\/a><\/sup>\u2014is arguably best seen in the transition from the apothecary and pharmacist to the large-scale pharmaceutical manufacturer. During this time of change in the late 1800s, laws dictating higher manufacturing quality, educational requirements, and restrictions on who can sell medicines were derided, debated, or cheered, depending on who was involved.<sup id=\"rdp-ebb-cite_ref-LillyTheRel83_23-0\" class=\"reference\"><a href=\"#cite_note-LillyTheRel83-23\">[23]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ParkerSomeAsp96_24-0\" class=\"reference\"><a href=\"#cite_note-ParkerSomeAsp96-24\">[24]<\/a><\/sup>\n<\/p><p>Reading for a meeting at the Kings County Pharmaceutical Society of Ohio, Charles E. Parker had the following to say about the state of the apothecary-turned-pharmacist in 1896, which fully highlights the transition from small-scale private to larger-scale industrial manufacturing of pharmaceuticals<sup id=\"rdp-ebb-cite_ref-ParkerSomeAsp96_24-1\" class=\"reference\"><a href=\"#cite_note-ParkerSomeAsp96-24\">[24]<\/a><\/sup>:\n<\/p>\n<blockquote><p>The modern pharmacist succeeds to all the responsibilities and obligations of the ancient apothecary without opposition, but his utmost efforts have not preserved to him his inheritance of former privileges and emoluments ... Technical skill is of no use to the professional side of pharmacy unless it is used, and used for the public welfare as well as that of its possessor. The dispenser is the <i>typical<\/i> pharmacist. But where in former years his sphere included many activities and much manipulative expertness in the preparation of drugs, and even the production of many of them, the modern tendency is for him to become a mere compounder and dispenser. Of course he is expected to know how, but actually is seldom required to perform the operations once a matter of constant routine. Step by step the productive processes of his little laboratory have been transferred to the works of large manufacturers. Year by year the pharmaceutical improvements and useful inventions which would once have conferred reputation and profit upon the dispensing pharmacies where they originated, have found a better market through these same manufacturers ... In addition, it is to be considered that some of the requisites of modern pharmacy are of a nature involving the use of expensive machinery and large plant, which places their production quite beyond the reach of the pharmacy.<\/p><\/blockquote>\n<p>Writing for the <i>Pharmaceutical Review<\/i> in 1897, editor Dr. Edward Kremers penned an editorial on the role of the manufacturing laboratory in the growing pharmaceutical industry, noting that \"[d]uring the past hundred years a most remarkable industrial revolution has taken place,\" and that pharmacy was also victim to that, lamenting that the apothecaries of the beginning of the century\u2014along with the druggists of 1897\u2014had largely become \"relics of the past.\"<sup id=\"rdp-ebb-cite_ref-KremersTheManu97_25-0\" class=\"reference\"><a href=\"#cite_note-KremersTheManu97-25\">[25]<\/a><\/sup> Kremers also touched upon another complaint popular at the time: that of pharmacy as a money-making venture.<sup id=\"rdp-ebb-cite_ref-TWDDrugClerks02_22-1\" class=\"reference\"><a href=\"#cite_note-TWDDrugClerks02-22\">[22]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KremersTheManu97_25-1\" class=\"reference\"><a href=\"#cite_note-KremersTheManu97-25\">[25]<\/a><\/sup> In his editorial, Kremers said:\n<\/p>\n<blockquote><p>It is a hope cherished by some that higher education will revolutionize pharmacy of today and lift her out of her present unenviable situation. The manufacturing industries, however, have revolutionized pharmacy of fifty years ago and are to no small extent coresponsible for the present state of affairs. The pharmaceutical profession as a whole is justified in asking what a particular branch is doing for the general good. Is the pharmaceutical manufacturer in the erection of his buildings, in the equipment of his laboratories and in the selection of his working force simply bent upon making so many thousands of dollars a paying investment, viewed from a merely commercial standpoint, or are his doings influenced to some extent to at least by higher than purely necessary motives.<\/p><\/blockquote>\n<p>By the early years of 1900, recognition of the sea-level change to the apothecary, pharmacist, and manufacturing laboratory had arguably gained traction, and by 1920 it was largely accepted<sup id=\"rdp-ebb-cite_ref-BealAward19_26-0\" class=\"reference\"><a href=\"#cite_note-BealAward19-26\">[26]<\/a><\/sup>. Writing for <i>The Rocky Mountain Druggist<\/i> in 1908, pharmaceutical doctor Geo H. Meeker laid it out in no uncertain terms: \n<\/p>\n<blockquote><p>Large manufacturing establishments can, for the most part, furnish the druggist at lower prices, with better authentic goods than he himself could produce, assay and guarantee. The inevitable result is that the druggist of today purchases finished products rather than raw materials as did the apothecary of yesterday. It is obvious that a large manufacturing establishment, conducted on ethical lines, employing a complete corps of specialists, buying raw materials to the best advantage and by assay only, making preparations on a large and intelligent technical scale and testing and assaying the finished products, does a work that is too immense in its scope for the individual apothecary ... Our present remnant of the drug store laboratory is, as in the past, essentially a manufacturing laboratory. It is of limited and rapidly vanishing scope because the small local laboratory man cannot successfully compete with his rivals, the great and highly-organized factories.<\/p><\/blockquote>\n<p>Similar comments were being made by Pearson in 1911<sup id=\"rdp-ebb-cite_ref-PearsonThePrep11_19-1\" class=\"reference\"><a href=\"#cite_note-PearsonThePrep11-19\">[19]<\/a><\/sup>, Thiesing in 1915<sup id=\"rdp-ebb-cite_ref-Thiesing15_27-0\" class=\"reference\"><a href=\"#cite_note-Thiesing15-27\">[27]<\/a><\/sup>, and Beal in 1919.<sup id=\"rdp-ebb-cite_ref-BealAward19_26-1\" class=\"reference\"><a href=\"#cite_note-BealAward19-26\">[26]<\/a><\/sup> Beal in particular spoke solemnly of the transition, largely complete by the time of his acceptance of the Joseph P. Remington Honor Medal in 1919. Speaking of Remington and his experiences in pharmacy, until his death in 1918, Beal said<sup id=\"rdp-ebb-cite_ref-BealAward19_26-2\" class=\"reference\"><a href=\"#cite_note-BealAward19-26\">[26]<\/a><\/sup>:\n<\/p>\n<blockquote><p>Professor Remington's professional experience bridged the space between two distinct periods of pharmaceutical development. When he began his apprenticeship the apothecary, as he was then commonly called, was the principal manufacturer as well as the purveyor of medical supplies ... He lived to see the period when the apothecary ceased to be the principal producer of medicinal compounds and became mainly the purveyor of preparations manufactured by others, and when the medicinal agents in most common use assumed a character that required for the successful production the resources of establishments maintained by large aggregations of capital and employing large numbers of specially trained workers.<br \/> <br \/>To those who knew him intimately it was evident that although Professor Remington did not welcome the passing of the manufacturing functions of the apothecary to the large laboratory, he at length came to realize that such a change was inevitable, that it was but a natural step in the process of social evolution, and that the logical action of the apothecary was not to resist that which he could neither prevent nor change, but to readjust himself to the new conditions.<\/p><\/blockquote>\n<p>Of course, by then, the rise of the industrial research lab within large-scale manufacturing enterprises was in full swing.\n<\/p>\n<h4><span id=\"rdp-ebb-1.1.3_The_rise_of_the_industrial_research_lab_within_large-scale_manufacturing,_and_today's_manufacturing_landscape\"><\/span><span class=\"mw-headline\" id=\"1.1.3_The_rise_of_the_industrial_research_lab_within_large-scale_manufacturing.2C_and_today.27s_manufacturing_landscape\">1.1.3 The rise of the industrial research lab within large-scale manufacturing, and today's manufacturing landscape<\/span><\/h4>\n<div class=\"floatleft\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:CSIRO_ScienceImage_1671_CSIR_Information_Stand.jpg\" class=\"image wiki-link\" data-key=\"aef4d809cf431f70c24991c0c70c6886\"><img alt=\"CSIRO ScienceImage 1671 CSIR Information Stand.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/e\/ee\/CSIRO_ScienceImage_1671_CSIR_Information_Stand.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>Like the small, privately owned manufacturing labs evolving to large-scale company-run manufacturing labs, so did the research processes of prior days. The individual tinkering with research in their private laboratory and making small batches of product gave way to a collective of individuals with more specialized talents cooperatively working in a large industrial manufacturing center towards a common, often complex research goal, i.e., within the industrial research laboratory.<sup id=\"rdp-ebb-cite_ref-MeesTheOrg20_28-0\" class=\"reference\"><a href=\"#cite_note-MeesTheOrg20-28\">[28]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BoydPutting24_29-0\" class=\"reference\"><a href=\"#cite_note-BoydPutting24-29\">[29]<\/a><\/sup> Those larger manufacturing entities that didn't have an industrial research lab were beginning to assess the value of adding one, while smaller enterprises that didn't have the resources to support an extensive collection of manufacturing and research labs were increasingly joining forces \"to maintain laboratories doing work for the whole industry.\"<sup id=\"rdp-ebb-cite_ref-MeesTheOrg20_28-1\" class=\"reference\"><a href=\"#cite_note-MeesTheOrg20-28\">[28]<\/a><\/sup> \n<\/p><p>But what drove the advance of the industrial research lab? As the National Research Council pointed out in 1940, \"individuals working independently could not, for very long, provide the technical and scientific knowledge essential to a rapidly developing industrial nation.\"<sup id=\"rdp-ebb-cite_ref-NRCRsearch40_30-0\" class=\"reference\"><a href=\"#cite_note-NRCRsearch40-30\">[30]<\/a><\/sup> Newly emerging industries had a need for new knowledge to feed their growth, and they proved to be the early adopters of establishing separate research departments or divisions in their businesses, unlike businesses in long-established industries. The First World War was also responsible for driving organized research efforts in various industries to solve not only wartime problems but also plant the seed of development in peacetime industries. By 1920, two-thirds of all research workers surveyed by the National Research Council were employed in the emerging electrical, chemical, and rubber industries, though the overall adoption of industrial research approaches was still limited across all companies.<sup id=\"rdp-ebb-cite_ref-NRCRsearch40_30-1\" class=\"reference\"><a href=\"#cite_note-NRCRsearch40-30\">[30]<\/a><\/sup> \n<\/p><p>In 1917, the previously mentioned Charles McDowell presented his view of American research and manufacturing methods of his time, referring to research as \"diligent inquiry.\"<sup id=\"rdp-ebb-cite_ref-McDowellAmerican17_14-1\" class=\"reference\"><a href=\"#cite_note-McDowellAmerican17-14\">[14]<\/a><\/sup> In his work, McDowell stated three types of research that leads up to the manufacturing process: pure scientific inquiry, industrial research, and factory research. He noted that of pure scientific inquiry, little thought is typically given to whether the research\u2014often conducted by university professors\u2014will have any real commercial value, though such value is able to emerge from this fundamental research. As for factory research, McDowell characterized it as full-scale factory-level operations that range from haphazard approaches to well-calculated contingency planning, all of which could make or break the manufacturing business.\n<\/p><p>In regards to the middle category of industrial research, McDowell made several observations that aptly described the state of manufacturing research in the early 1900s. He noted that unlike pure scientific inquiry, industrial research had commercial practicality as a goal, often beginning with small-scale experiments while later seeking how to reproduce those theoretical results into large-scale manufacturing. He also reiterated his point about needing to \"have good backing\" financially. \"The larger manufacturer maintains his own staff and equipment to carry out investigations along any line that may seem desirable,\" he said, \"but the smaller industries are not able to support an establishment and must rely on either consulting engineers or turn their problems over to some equipped public or private laboratory to solve.\"<sup id=\"rdp-ebb-cite_ref-McDowellAmerican17_14-2\" class=\"reference\"><a href=\"#cite_note-McDowellAmerican17-14\">[14]<\/a><\/sup> \n<\/p><p>In his 1920 book <i>The Organization of Industrial Scientific Research<\/i>, Mees presented these three types of research somewhat similarly, though in the context of the industrial laboratory and its operations. Mees argued that industrial laboratories could be classified into three divisions<sup id=\"rdp-ebb-cite_ref-MeesTheOrg20_28-2\" class=\"reference\"><a href=\"#cite_note-MeesTheOrg20-28\">[28]<\/a><\/sup>:\n<\/p>\n<ul><li>Laboratories \"working on pure theory and the fundamental sciences associated with the industry,\" aligning in part with McDowell's \"pure scientific inquiry\";<\/li>\n<li>Work laboratories \"exerting analytical control over materials, processes and product,\" aligning slightly with McDowell's \"factory research\" but more akin to the modern quality control lab; and<\/li>\n<li>Industrial laboratories \"working on improvements in product and in processes,\" aligning with McDowell's \"industrial research.\"<\/li><\/ul>\n<p>Mees argued in particular that those industrial research laboratories that simply improve products and processes were not doing enough; they should, necessarily, also direct some of their goals towards more fully understanding the fundamental and underlying theory of the topic of research.<sup id=\"rdp-ebb-cite_ref-MeesTheOrg20_28-3\" class=\"reference\"><a href=\"#cite_note-MeesTheOrg20-28\">[28]<\/a><\/sup> In other words, Mees suggested that those labs simply working on theoretical and fundamental science research, as well as those labs conducting industrial research to improve products and processes, shouldn't necessarily function in separate vacuums. \"Research work of this fundamental kind involves a laboratory very different from the usual works laboratory and also investigators of a different type from those employed in a purely industrial laboratory,\" he noted. Of course, this hybrid approach to fundamental and industrial research was largely reserved for the largest of manufacturers, and solutions were needed for smaller manufacturing endeavors. Here, like McDowell in 1917, Mees argued for smaller businesses with limited resources to adopt both cooperative laboratory (those businesses that pool resources together for a fully supported research laboratory) and consulting laboratory (a third-party lab with the resources to fully study a problem, undertake investigations, model a manufacturing process, and implement that process into its client's factory, all for a fee) approaches.<sup id=\"rdp-ebb-cite_ref-MeesTheOrg20_28-4\" class=\"reference\"><a href=\"#cite_note-MeesTheOrg20-28\">[28]<\/a><\/sup> With such solutions, the industrial research laboratory continued to take on a new level of complexity to address emerging industry needs, far from the humble origins of an early nineteenth-century manufacturing laboratory.\n<\/p><p>This growth or industrial research would continue onward from the twentieth century into the twenty-first century. In 1921, some 15 companies maintained research groups of more than 50 people; by 1938, there were 120 such businesses.<sup id=\"rdp-ebb-cite_ref-NRCRsearch40_30-2\" class=\"reference\"><a href=\"#cite_note-NRCRsearch40-30\">[30]<\/a><\/sup> By the 1990s, \"the share of funding for basic research provided by industry actually grew from 10 percent to 25 percent of the national total, even though basic research accounted for just 5-7 percent of total R&D expenditures by industry.\"<sup id=\"rdp-ebb-cite_ref-UsselmanResearch13_31-0\" class=\"reference\"><a href=\"#cite_note-UsselmanResearch13-31\">[31]<\/a><\/sup> This trend of large research groups continues today, though with the recognition that smaller teams may still have advantages. In a 2019 article in the <i>Harvard Business Review<\/i>, Wang and Evans recognize \"large teams as optimal engines for tomorrow\u2019s largest advances,\" while smaller research teams are better poised to ask disruptive questions and make innovative discoveries.<sup id=\"rdp-ebb-cite_ref-WangResearch19_32-0\" class=\"reference\"><a href=\"#cite_note-WangResearch19-32\">[32]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-CarrDeliver22-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CarrDeliver22_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Carr, T.; Chewning, E.; Doheny, M. et al. (29 August 2022). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mckinsey.com\/capabilities\/operations\/our-insights\/delivering-the-us-manufacturing-renaissance\" target=\"_blank\">\"Delivering the US manufacturing renaissance\"<\/a>. <i>McKinsey & Company<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.mckinsey.com\/capabilities\/operations\/our-insights\/delivering-the-us-manufacturing-renaissance\" target=\"_blank\">https:\/\/www.mckinsey.com\/capabilities\/operations\/our-insights\/delivering-the-us-manufacturing-renaissance<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Delivering+the+US+manufacturing+renaissance&rft.atitle=McKinsey+%26+Company&rft.aulast=Carr%2C+T.%3B+Chewning%2C+E.%3B+Doheny%2C+M.+et+al.&rft.au=Carr%2C+T.%3B+Chewning%2C+E.%3B+Doheny%2C+M.+et+al.&rft.date=29+August+2022&rft_id=https%3A%2F%2Fwww.mckinsey.com%2Fcapabilities%2Foperations%2Four-insights%2Fdelivering-the-us-manufacturing-renaissance&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-2\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Ischi, H. P.; Radvila, P. R. (17 January 1997). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/link.springer.com\/10.1007\/s007690050092\" target=\"_blank\">\"Accreditation and quality assurance in Swiss chemical laboratories\"<\/a>. <i>Accreditation and Quality Assurance<\/i> <b>2<\/b> (1): 36\u201339. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2Fs007690050092\" target=\"_blank\">10.1007\/s007690050092<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" data-key=\"a5dec3e4d005e654c29ad167ab53f53a\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/issn\/0949-1775\" target=\"_blank\">0949-1775<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/link.springer.com\/10.1007\/s007690050092\" target=\"_blank\">http:\/\/link.springer.com\/10.1007\/s007690050092<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Accreditation+and+quality+assurance+in+Swiss+chemical+laboratories&rft.jtitle=Accreditation+and+Quality+Assurance&rft.aulast=Ischi&rft.aufirst=H.+P.&rft.au=Ischi%2C%26%2332%3BH.+P.&rft.au=Radvila%2C%26%2332%3BP.+R.&rft.date=17+January+1997&rft.volume=2&rft.issue=1&rft.pages=36%E2%80%9339&rft_id=info:doi\/10.1007%2Fs007690050092&rft.issn=0949-1775&rft_id=http%3A%2F%2Flink.springer.com%2F10.1007%2Fs007690050092&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-3\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Crow, Michael M.; Bozeman, Barry (1998). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?hl=en&lr=&id=OVPZvqz2e6UC\" target=\"_blank\">\"Chapter 1: The Sixteen Thousand: Policy Analysis, R&D Laboratories, and the National Innovation System\"<\/a>. <i>Limited by design: R&D laboratories in the U.S. national innovation system<\/i>. New York: Columbia University Press. pp. 1\u201340. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-585-04137-7<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?hl=en&lr=&id=OVPZvqz2e6UC\" target=\"_blank\">https:\/\/books.google.com\/books?hl=en&lr=&id=OVPZvqz2e6UC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+1%3A+The+Sixteen+Thousand%3A+Policy+Analysis%2C+R%26D+Laboratories%2C+and+the+National+Innovation+System&rft.atitle=Limited+by+design%3A+R%26D+laboratories+in+the+U.S.+national+innovation+system&rft.aulast=Crow&rft.aufirst=Michael+M.&rft.au=Crow%2C%26%2332%3BMichael+M.&rft.au=Bozeman%2C%26%2332%3BBarry&rft.date=1998&rft.pages=pp.%26nbsp%3B1%E2%80%9340&rft.place=New+York&rft.pub=Columbia+University+Press&rft.isbn=978-0-585-04137-7&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fhl%3Den%26lr%3D%26id%3DOVPZvqz2e6UC&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-4\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Grochau, In\u00eas Hexsel; ten Caten, Carla Schwengber (1 October 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/link.springer.com\/10.1007\/s00769-012-0905-3\" target=\"_blank\">\"A process approach to ISO\/IEC 17025 in the implementation of a quality management system in testing laboratories\"<\/a> (in en). <i>Accreditation and Quality Assurance<\/i> <b>17<\/b> (5): 519\u2013527. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2Fs00769-012-0905-3\" target=\"_blank\">10.1007\/s00769-012-0905-3<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" data-key=\"a5dec3e4d005e654c29ad167ab53f53a\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/issn\/0949-1775\" target=\"_blank\">0949-1775<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/link.springer.com\/10.1007\/s00769-012-0905-3\" target=\"_blank\">http:\/\/link.springer.com\/10.1007\/s00769-012-0905-3<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=A+process+approach+to+ISO%2FIEC+17025+in+the+implementation+of+a+quality+management+system+in+testing+laboratories&rft.jtitle=Accreditation+and+Quality+Assurance&rft.aulast=Grochau&rft.aufirst=In%C3%AAs+Hexsel&rft.au=Grochau%2C%26%2332%3BIn%C3%AAs+Hexsel&rft.au=ten+Caten%2C%26%2332%3BCarla+Schwengber&rft.date=1+October+2012&rft.volume=17&rft.issue=5&rft.pages=519%E2%80%93527&rft_id=info:doi\/10.1007%2Fs00769-012-0905-3&rft.issn=0949-1775&rft_id=http%3A%2F%2Flink.springer.com%2F10.1007%2Fs00769-012-0905-3&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-5\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Ribeiro, \u00c0.S.; Gust, J.; Vilhena, A. et al. (2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.imeko.info\/index.php\/proceedings\/7687-the-role-of-laboratories-in-the-international-development-of-accreditation\" target=\"_blank\">\"The role of laboratories in the international development of accreditation\"<\/a>. <i>Proceedings of the 16th IMEKO TC10 Conference \"Testing, Diagnostics & Inspection as a comprehensive value chain for Quality & Safety\"<\/i>: 56\u20139<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.imeko.info\/index.php\/proceedings\/7687-the-role-of-laboratories-in-the-international-development-of-accreditation\" target=\"_blank\">https:\/\/www.imeko.info\/index.php\/proceedings\/7687-the-role-of-laboratories-in-the-international-development-of-accreditation<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+role+of+laboratories+in+the+international+development+of+accreditation&rft.jtitle=Proceedings+of+the+16th+IMEKO+TC10+Conference+%22Testing%2C+Diagnostics+%26+Inspection+as+a+comprehensive+value+chain+for+Quality+%26+Safety%22&rft.aulast=Ribeiro%2C+%C3%80.S.%3B+Gust%2C+J.%3B+Vilhena%2C+A.+et+al.&rft.au=Ribeiro%2C+%C3%80.S.%3B+Gust%2C+J.%3B+Vilhena%2C+A.+et+al.&rft.date=2019&rft.pages=56%E2%80%939&rft_id=https%3A%2F%2Fwww.imeko.info%2Findex.php%2Fproceedings%2F7687-the-role-of-laboratories-in-the-international-development-of-accreditation&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BLSManufact23-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BLSManufact23_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bls.gov\/iag\/tgs\/iag31-33.htm\" target=\"_blank\">\"Manufacturing: NAICS 31-33\"<\/a>. <i>Industries at a Glance<\/i>. U.S. Bureau of Labor Statistics. 5 May 2023<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.bls.gov\/iag\/tgs\/iag31-33.htm\" target=\"_blank\">https:\/\/www.bls.gov\/iag\/tgs\/iag31-33.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Manufacturing%3A+NAICS+31-33&rft.atitle=Industries+at+a+Glance&rft.date=5+May+2023&rft.pub=U.S.+Bureau+of+Labor+Statistics&rft_id=https%3A%2F%2Fwww.bls.gov%2Fiag%2Ftgs%2Fiag31-33.htm&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AntisellPutnamArts52-7\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-AntisellPutnamArts52_7-0\">7.0<\/a><\/sup> <sup><a href=\"#cite_ref-AntisellPutnamArts52_7-1\">7.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Antisell, T. (1852). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=vsI0AAAAMAAJ&pg=PA284\" target=\"_blank\"><i>Putnam's Home Cyclopedia: Hand-Book of the Useful Arts<\/i><\/a>. <b>3<\/b>. George P. Putnam. pp. 284-5<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=vsI0AAAAMAAJ&pg=PA284\" target=\"_blank\">https:\/\/books.google.com\/books?id=vsI0AAAAMAAJ&pg=PA284<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 31 March 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Putnam%27s+Home+Cyclopedia%3A+Hand-Book+of+the+Useful+Arts&rft.aulast=Antisell%2C+T.&rft.au=Antisell%2C+T.&rft.date=1852&rft.volume=3&rft.pages=pp.%26nbsp%3B284-5&rft.pub=George+P.+Putnam&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DvsI0AAAAMAAJ%26pg%3DPA284&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PorterTheChem30-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PorterTheChem30_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Porter, A.L. (1830). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=zy8aAAAAYAAJ&pg=PA17&dq=manufacturing+laboratory\" target=\"_blank\">\"Chemistry Applied to the Arts\"<\/a>. <i>The Chemistry of the Arts; being a Practical Display of the Arts and Manufactures which Depend on Chemical Principles<\/i>. Carey & Lea. pp. 17\u201318<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=zy8aAAAAYAAJ&pg=PA17&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=zy8aAAAAYAAJ&pg=PA17&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>. \"The larger laboratories, or workshops, which are used only in particular branches of business, and the necessary apparatus attached to them, will be considered under the several substances which are prepared in them. Besides the workshop, every operative chemist ought to devote some part of his premises as a small general elaboratory, fitted up with some furnaces and other apparatus as may enable him to make any experiment seemingly applicable to the improvement of his manufacturing process without loss of time, and immediately upon its inception.\"<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chemistry+Applied+to+the+Arts&rft.atitle=The+Chemistry+of+the+Arts%3B+being+a+Practical+Display+of+the+Arts+and+Manufactures+which+Depend+on+Chemical+Principles&rft.aulast=Porter%2C+A.L.&rft.au=Porter%2C+A.L.&rft.date=1830&rft.pages=pp.%26nbsp%3B17%E2%80%9318&rft.pub=Carey+%26+Lea&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Dzy8aAAAAYAAJ%26pg%3DPA17%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MarshSpeech46-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MarshSpeech46_9-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Marsh, G. P. (1846). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=ptg-AAAAYAAJ&pg=PA11&dq=manufacturing+laboratory\" target=\"_blank\"><i>Speech of Mr. Marsh, of Vermont, on the Hill for Establishing the Smithsonian Institution, Delivered in The House of Representatives of the U. States, April 22, 1846<\/i><\/a>. J. & G.S. Gideon. p. 11<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=ptg-AAAAYAAJ&pg=PA11&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=ptg-AAAAYAAJ&pg=PA11&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>. \"How are new substances formed, or the stock of a given substance increased, by the chemistry of nature or of art? By new combinations or decompositions of known and pre-existing elements. The products of the experimental or manufacturing laboratory are no new creations; but their elements are first extracted by the decomposition of old components, and then recombined in new forms.\"<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Speech+of+Mr.+Marsh%2C+of+Vermont%2C+on+the+Hill+for+Establishing+the+Smithsonian+Institution%2C+Delivered+in+The+House+of+Representatives+of+the+U.+States%2C+April+22%2C+1846&rft.aulast=Marsh%2C+G.+P.&rft.au=Marsh%2C+G.+P.&rft.date=1846&rft.pages=p.%26nbsp%3B11&rft.pub=J.+%26+G.S.+Gideon&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Dptg-AAAAYAAJ%26pg%3DPA11%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AllenAHist11-10\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-AllenAHist11_10-0\">10.0<\/a><\/sup> <sup><a href=\"#cite_ref-AllenAHist11_10-1\">10.1<\/a><\/sup> <sup><a href=\"#cite_ref-AllenAHist11_10-2\">10.2<\/a><\/sup> <sup><a href=\"#cite_ref-AllenAHist11_10-3\">10.3<\/a><\/sup> <sup><a href=\"#cite_ref-AllenAHist11_10-4\">10.4<\/a><\/sup> <sup><a href=\"#cite_ref-AllenAHist11_10-5\">10.5<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Allen Jr., L.V. (2011). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20130128014521\/https:\/\/www.perrigo.com\/business\/pdfs\/Sec%20Artem%2011.3.pdf\" target=\"_blank\">\"A History of Pharmaceutical Compounding\"<\/a> (PDF). <i>Secundum Artem<\/i> <b>11<\/b> (3). Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.perrigo.com\/business\/pdfs\/Sec%20Artem%2011.3.pdf\" target=\"_blank\">the original<\/a> on 28 January 2013<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20130128014521\/https:\/\/www.perrigo.com\/business\/pdfs\/Sec%20Artem%2011.3.pdf\" target=\"_blank\">https:\/\/web.archive.org\/web\/20130128014521\/https:\/\/www.perrigo.com\/business\/pdfs\/Sec%20Artem%2011.3.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=A+History+of+Pharmaceutical+Compounding&rft.jtitle=Secundum+Artem&rft.aulast=Allen+Jr.%2C+L.V.&rft.au=Allen+Jr.%2C+L.V.&rft.date=2011&rft.volume=11&rft.issue=3&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20130128014521%2Fhttps%3A%2F%2Fwww.perrigo.com%2Fbusiness%2Fpdfs%2FSec%2520Artem%252011.3.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Plough97-11\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-Plough97_11-0\">11.0<\/a><\/sup> <sup><a href=\"#cite_ref-Plough97_11-1\">11.1<\/a><\/sup> <sup><a href=\"#cite_ref-Plough97_11-2\">11.2<\/a><\/sup> <sup><a href=\"#cite_ref-Plough97_11-3\">11.3<\/a><\/sup> <sup><a href=\"#cite_ref-Plough97_11-4\">11.4<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.google.com\/books\/edition\/Pharmaceutical_Journal\/ScDyXwC8McwC?hl=en&gbpv=1&dq=manufacturing+laboratory&pg=PA164&printsec=frontcover\" target=\"_blank\">\"The Plough Court Pharmacy\"<\/a>. <i>The Pharmaceutical Journal<\/i> (Pharmaceutical Society of Great Britain) <b>LVIII<\/b>: 164\u20137, 247\u201351. January to June 1897<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.google.com\/books\/edition\/Pharmaceutical_Journal\/ScDyXwC8McwC?hl=en&gbpv=1&dq=manufacturing+laboratory&pg=PA164&printsec=frontcover\" target=\"_blank\">https:\/\/www.google.com\/books\/edition\/Pharmaceutical_Journal\/ScDyXwC8McwC?hl=en&gbpv=1&dq=manufacturing+laboratory&pg=PA164&printsec=frontcover<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Plough+Court+Pharmacy&rft.jtitle=The+Pharmaceutical+Journal&rft.date=January+to+June+1897&rft.volume=LVIII&rft.pages=164%E2%80%937%2C+247%E2%80%9351&rft.pub=Pharmaceutical+Society+of+Great+Britain&rft_id=https%3A%2F%2Fwww.google.com%2Fbooks%2Fedition%2FPharmaceutical_Journal%2FScDyXwC8McwC%3Fhl%3Den%26gbpv%3D1%26dq%3Dmanufacturing%2Blaboratory%26pg%3DPA164%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AndersonPharm13-12\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AndersonPharm13_12-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Anderson, S.C. (2013). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.histpharm.org\/ISHPWG%20UK.pdf\" target=\"_blank\">\"Pharmacopoeias of Great Britain\"<\/a> (PDF). <i>A History of the Pharmacopoeias of the World<\/i>. International Society for the History of Pharmacy. pp. 1\u20138<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.histpharm.org\/ISHPWG%20UK.pdf\" target=\"_blank\">http:\/\/www.histpharm.org\/ISHPWG%20UK.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Pharmacopoeias+of+Great+Britain&rft.atitle=A+History+of+the+Pharmacopoeias+of+the+World&rft.aulast=Anderson%2C+S.C.&rft.au=Anderson%2C+S.C.&rft.date=2013&rft.pages=pp.+1%E2%80%938&rft.pub=International+Society+for+the+History+of+Pharmacy&rft_id=http%3A%2F%2Fwww.histpharm.org%2FISHPWG%2520UK.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DCTheEarly18-13\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-DCTheEarly18_13-0\">13.0<\/a><\/sup> <sup><a href=\"#cite_ref-DCTheEarly18_13-1\">13.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=P3kgAQAAMAAJ&pg=RA2-PA243-IA1&dq=manufacturing+laboratory\" target=\"_blank\">\"The Early Days of Pharmaceutical\"<\/a>. <i>The Druggists Circular<\/i> <b>LXII<\/b> (6): 244\u20135. June 1918<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=P3kgAQAAMAAJ&pg=RA2-PA243-IA1&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=P3kgAQAAMAAJ&pg=RA2-PA243-IA1&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Early+Days+of+Pharmaceutical&rft.jtitle=The+Druggists+Circular&rft.date=June+1918&rft.volume=LXII&rft.issue=6&rft.pages=244%E2%80%935&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DP3kgAQAAMAAJ%26pg%3DRA2-PA243-IA1%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-McDowellAmerican17-14\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-McDowellAmerican17_14-0\">14.0<\/a><\/sup> <sup><a href=\"#cite_ref-McDowellAmerican17_14-1\">14.1<\/a><\/sup> <sup><a href=\"#cite_ref-McDowellAmerican17_14-2\">14.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">McDowell, C.A. (1917). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=8pMPAQAAIAAJ&pg=PA546&dq=manufacturing+laboratory\" target=\"_blank\">\"American Research Methods\"<\/a>. <i>Journal of the Western Society of Engineers<\/i> <b>XXII<\/b> (8): 546\u201365<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=8pMPAQAAIAAJ&pg=PA546&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=8pMPAQAAIAAJ&pg=PA546&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=American+Research+Methods&rft.jtitle=Journal+of+the+Western+Society+of+Engineers&rft.aulast=McDowell%2C+C.A.&rft.au=McDowell%2C+C.A.&rft.date=1917&rft.volume=XXII&rft.issue=8&rft.pages=546%E2%80%9365&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3D8pMPAQAAIAAJ%26pg%3DPA546%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RobertsonDesulph43-15\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RobertsonDesulph43_15-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Robertson, J.C., ed. (1 July 1843). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=3u01AQAAMAAJ&pg=RA1-PA444&dq=manufacturing+laboratory\" target=\"_blank\">\"Desulphuration of Metals\"<\/a>. <i>Mechanics' Magazine, Museum, Register, Journal, and Gazette<\/i> <b>38<\/b>: 444<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=3u01AQAAMAAJ&pg=RA1-PA444&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=3u01AQAAMAAJ&pg=RA1-PA444&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Desulphuration+of+Metals&rft.jtitle=Mechanics%27+Magazine%2C+Museum%2C+Register%2C+Journal%2C+and+Gazette&rft.date=1+July+1843&rft.volume=38&rft.pages=444&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3D3u01AQAAMAAJ%26pg%3DRA1-PA444%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JacksonChemical43-16\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-JacksonChemical43_16-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Jackson, C.T. (31 May 1843). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=hrYxAQAAMAAJ&pg=PA379&dq=manufacturing+laboratory\" target=\"_blank\">\"Chemical Salts as Fertilizers\"<\/a>. <i>New England Farmer, and Horticultural Register<\/i> (Joseph Breck & Co) <b>XXL<\/b> (48): 379<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=hrYxAQAAMAAJ&pg=PA379&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=hrYxAQAAMAAJ&pg=PA379&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Chemical+Salts+as+Fertilizers&rft.jtitle=New+England+Farmer%2C+and+Horticultural+Register&rft.aulast=Jackson%2C+C.T.&rft.au=Jackson%2C+C.T.&rft.date=31+May+1843&rft.volume=XXL&rft.issue=48&rft.pages=379&rft.pub=Joseph+Breck+%26+Co&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DhrYxAQAAMAAJ%26pg%3DPA379%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-UmneySulphurous69-17\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-UmneySulphurous69_17-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Umney, C. (1869). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=POkKAAAAYAAJ&pg=PA516&dq=manufacturing+laboratory\" target=\"_blank\">\"Sulphurous Acid\"<\/a>. <i>Pharmaceutical Journal and Transactions<\/i> (John Churchill and Sons) <b>X<\/b> (IX): 516\u201320<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=POkKAAAAYAAJ&pg=PA516&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=POkKAAAAYAAJ&pg=PA516&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Sulphurous+Acid&rft.jtitle=Pharmaceutical+Journal+and+Transactions&rft.aulast=Umney%2C+C.&rft.au=Umney%2C+C.&rft.date=1869&rft.volume=X&rft.issue=IX&rft.pages=516%E2%80%9320&rft.pub=John+Churchill+and+Sons&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DPOkKAAAAYAAJ%26pg%3DPA516%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CrookesOnThe63-18\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CrookesOnThe63_18-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Crookes, W. (April 1863). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=0JHOIc5pHYwC&pg=PA172&dq=manufacturing+laboratory\" target=\"_blank\">\"On the Discovery of the Metal Thallium\"<\/a>. <i>The Chemical News and Journal of Physical Chemistry<\/i> <b>VII<\/b> (175): 172\u20136<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=0JHOIc5pHYwC&pg=PA172&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=0JHOIc5pHYwC&pg=PA172&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=On+the+Discovery+of+the+Metal+Thallium&rft.jtitle=The+Chemical+News+and+Journal+of+Physical+Chemistry&rft.aulast=Crookes%2C+W.&rft.au=Crookes%2C+W.&rft.date=April+1863&rft.volume=VII&rft.issue=175&rft.pages=172%E2%80%936&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3D0JHOIc5pHYwC%26pg%3DPA172%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PearsonThePrep11-19\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-PearsonThePrep11_19-0\">19.0<\/a><\/sup> <sup><a href=\"#cite_ref-PearsonThePrep11_19-1\">19.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Pearson, W.A. (April 1911). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=GyFFAQAAMAAJ&pg=PA415&dq=manufacturing+laboratory\" target=\"_blank\">\"The Preparation and Testing of Drugs\"<\/a>. <i>The Journal of the Franklin Institute of the State of Pennsylvania<\/i> <b>CLXXI<\/b> (4): 415\u201321<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=GyFFAQAAMAAJ&pg=PA415&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=GyFFAQAAMAAJ&pg=PA415&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>. \"All the large drug laboratories have been developed since 1860 ... The increase in number of manufacturing laboratories and the consequent increase in competition exerted an influence on the wholesale druggist.\"<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Preparation+and+Testing+of+Drugs&rft.jtitle=The+Journal+of+the+Franklin+Institute+of+the+State+of+Pennsylvania&rft.aulast=Pearson%2C+W.A.&rft.au=Pearson%2C+W.A.&rft.date=April+1911&rft.volume=CLXXI&rft.issue=4&rft.pages=415%E2%80%9321&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DGyFFAQAAMAAJ%26pg%3DPA415%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LockingtonEnamled96-20\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LockingtonEnamled96_20-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Lockington, W.P. (April 1896). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=lj9PAQAAIAAJ&pg=RA1-PA350&dq=manufacturing+laboratory\" target=\"_blank\">\"Enamled Brick at Oaks, PA\"<\/a>. <i>The Clay-Worker<\/i> <b>XXV<\/b> (4): 350\u201351<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=lj9PAQAAIAAJ&pg=RA1-PA350&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=lj9PAQAAIAAJ&pg=RA1-PA350&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 April 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Enamled+Brick+at+Oaks%2C+PA&rft.jtitle=The+Clay-Worker&rft.aulast=Lockington%2C+W.P.&rft.au=Lockington%2C+W.P.&rft.date=April+1896&rft.volume=XXV&rft.issue=4&rft.pages=350%E2%80%9351&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Dlj9PAQAAIAAJ%26pg%3DRA1-PA350%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RobertsonReport86-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RobertsonReport86_21-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Robertson, W. (1886). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=a-AfAQAAIAAJ&pg=PA223&dq=manufacturing+laboratory\" target=\"_blank\">\"Report of Visit to the Laboratories of M. Pasteur at Paris\"<\/a>. <i>The Veterinary Journal and Annals of Comparative Pathology<\/i> <b>XXIII<\/b>: 223\u20137<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=a-AfAQAAIAAJ&pg=PA223&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=a-AfAQAAIAAJ&pg=PA223&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 April 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Report+of+Visit+to+the+Laboratories+of+M.+Pasteur+at+Paris&rft.jtitle=The+Veterinary+Journal+and+Annals+of+Comparative+Pathology&rft.aulast=Robertson%2C+W.&rft.au=Robertson%2C+W.&rft.date=1886&rft.volume=XXIII&rft.pages=223%E2%80%937&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Da-AfAQAAIAAJ%26pg%3DPA223%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-TWDDrugClerks02-22\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-TWDDrugClerks02_22-0\">22.0<\/a><\/sup> <sup><a href=\"#cite_ref-TWDDrugClerks02_22-1\">22.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">The Western Druggist (July 1902). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=qG8gAQAAMAAJ&pg=PA405&dq=manufacturing+laboratory\" target=\"_blank\">\"Drug Clerks and Labor Unions\"<\/a>. <i>The Western Druggist<\/i> <b>XXIV<\/b> (7): 405<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=qG8gAQAAMAAJ&pg=PA405&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=qG8gAQAAMAAJ&pg=PA405&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Drug+Clerks+and+Labor+Unions&rft.jtitle=The+Western+Druggist&rft.aulast=The+Western+Druggist&rft.au=The+Western+Druggist&rft.date=July+1902&rft.volume=XXIV&rft.issue=7&rft.pages=405&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DqG8gAQAAMAAJ%26pg%3DPA405%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LillyTheRel83-23\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LillyTheRel83_23-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Lilly, J.K. (January 1883). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=VlyFy6zJQpUC&pg=RA2-PA258&dq=manufacturing+laboratory\" target=\"_blank\">\"The Relation of Manufacturing Pharmacists to Pharmacy Laws\"<\/a>. <i>The Pharmacist and Chemist<\/i> <b>XVI<\/b> (1): 258\u20139<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=VlyFy6zJQpUC&pg=RA2-PA258&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=VlyFy6zJQpUC&pg=RA2-PA258&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Relation+of+Manufacturing+Pharmacists+to+Pharmacy+Laws&rft.jtitle=The+Pharmacist+and+Chemist&rft.aulast=Lilly%2C+J.K.&rft.au=Lilly%2C+J.K.&rft.date=January+1883&rft.volume=XVI&rft.issue=1&rft.pages=258%E2%80%939&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DVlyFy6zJQpUC%26pg%3DRA2-PA258%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ParkerSomeAsp96-24\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ParkerSomeAsp96_24-0\">24.0<\/a><\/sup> <sup><a href=\"#cite_ref-ParkerSomeAsp96_24-1\">24.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Parker, C.E. (25 March 1896). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=bSnnAAAAMAAJ&pg=PA183&dq=manufacturing+laboratory\" target=\"_blank\">\"Some Aspects of Technical Pharmacy\"<\/a>. <i>American Druggist and Pharmaceutical Record<\/i> <b>XXVIII<\/b> (6): 183\u20134<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=bSnnAAAAMAAJ&pg=PA183&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=bSnnAAAAMAAJ&pg=PA183&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Some+Aspects+of+Technical+Pharmacy&rft.jtitle=American+Druggist+and+Pharmaceutical+Record&rft.aulast=Parker%2C+C.E.&rft.au=Parker%2C+C.E.&rft.date=25+March+1896&rft.volume=XXVIII&rft.issue=6&rft.pages=183%E2%80%934&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DbSnnAAAAMAAJ%26pg%3DPA183%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KremersTheManu97-25\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-KremersTheManu97_25-0\">25.0<\/a><\/sup> <sup><a href=\"#cite_ref-KremersTheManu97_25-1\">25.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Kremers, E. (April 1897). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=4BU4AQAAMAAJ&pg=PA61&dq=manufacturing+laboratory\" target=\"_blank\">\"The Manufacturing Laboratory in the Household of Pharmacy\"<\/a>. <i>Pharmaceutical Review<\/i> <b>15<\/b> (4): 61\u20137<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=4BU4AQAAMAAJ&pg=PA61&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=4BU4AQAAMAAJ&pg=PA61&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Manufacturing+Laboratory+in+the+Household+of+Pharmacy&rft.jtitle=Pharmaceutical+Review&rft.aulast=Kremers%2C+E.&rft.au=Kremers%2C+E.&rft.date=April+1897&rft.volume=15&rft.issue=4&rft.pages=61%E2%80%937&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3D4BU4AQAAMAAJ%26pg%3DPA61%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BealAward19-26\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BealAward19_26-0\">26.0<\/a><\/sup> <sup><a href=\"#cite_ref-BealAward19_26-1\">26.1<\/a><\/sup> <sup><a href=\"#cite_ref-BealAward19_26-2\">26.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Diner, J.; Beal, J.H. (December 1919). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=GQlOAAAAMAAJ&pg=PA475&dq=manufacturing+laboratory\" target=\"_blank\">\"Award of the Joseph B. Remington Honor Medal\"<\/a>. <i>The Midland Druggist and Pharmaceutical Review<\/i> <b>LIII<\/b> (12): 475\u20139<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=GQlOAAAAMAAJ&pg=PA475&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=GQlOAAAAMAAJ&pg=PA475&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Award+of+the+Joseph+B.+Remington+Honor+Medal&rft.jtitle=The+Midland+Druggist+and+Pharmaceutical+Review&rft.aulast=Diner%2C+J.%3B+Beal%2C+J.H.&rft.au=Diner%2C+J.%3B+Beal%2C+J.H.&rft.date=December+1919&rft.volume=LIII&rft.issue=12&rft.pages=475%E2%80%939&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DGQlOAAAAMAAJ%26pg%3DPA475%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Thiesing15-27\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Thiesing15_27-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Thiesing, E.H. (October 1915). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=b_5EAQAAMAAJ&pg=PA1203&dq=manufacturing+laboratory\" target=\"_blank\">\"Proceedings of the Joint Session of the Commercial Section and Section on Education and Legislation - Chairman Thiesing's Address\"<\/a>. <i>The Journal of the Americam Pharmaceutical Association<\/i> <b>IV<\/b> (10)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=b_5EAQAAMAAJ&pg=PA1203&dq=manufacturing+laboratory\" target=\"_blank\">https:\/\/books.google.com\/books?id=b_5EAQAAMAAJ&pg=PA1203&dq=manufacturing+laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Proceedings+of+the+Joint+Session+of+the+Commercial+Section+and+Section+on+Education+and+Legislation+-+Chairman+Thiesing%27s+Address&rft.jtitle=The+Journal+of+the+Americam+Pharmaceutical+Association&rft.aulast=Thiesing%2C+E.H.&rft.au=Thiesing%2C+E.H.&rft.date=October+1915&rft.volume=IV&rft.issue=10&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Db_5EAQAAMAAJ%26pg%3DPA1203%26dq%3Dmanufacturing%2Blaboratory&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MeesTheOrg20-28\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-MeesTheOrg20_28-0\">28.0<\/a><\/sup> <sup><a href=\"#cite_ref-MeesTheOrg20_28-1\">28.1<\/a><\/sup> <sup><a href=\"#cite_ref-MeesTheOrg20_28-2\">28.2<\/a><\/sup> <sup><a href=\"#cite_ref-MeesTheOrg20_28-3\">28.3<\/a><\/sup> <sup><a href=\"#cite_ref-MeesTheOrg20_28-4\">28.4<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Mees, C.E.K. (1920). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=rDIuAAAAYAAJ&printsec=frontcover&dq=industrial+research+laboratories\" target=\"_blank\">\"Chapter 1: Introduction\"<\/a>. <i>The Organization of Industrial Scientific Research<\/i>. McGraw-Hill Book Company, Inc. pp. 4\u201310<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=rDIuAAAAYAAJ&printsec=frontcover&dq=industrial+research+laboratories\" target=\"_blank\">https:\/\/books.google.com\/books?id=rDIuAAAAYAAJ&printsec=frontcover&dq=industrial+research+laboratories<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+1%3A+Introduction&rft.atitle=The+Organization+of+Industrial+Scientific+Research&rft.aulast=Mees%2C+C.E.K.&rft.au=Mees%2C+C.E.K.&rft.date=1920&rft.pages=pp.%26nbsp%3B4%E2%80%9310&rft.pub=McGraw-Hill+Book+Company%2C+Inc&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DrDIuAAAAYAAJ%26printsec%3Dfrontcover%26dq%3Dindustrial%2Bresearch%2Blaboratories&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BoydPutting24-29\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BoydPutting24_29-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Boyd, T.A. (May 1938). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=lYkiAQAAMAAJ&pg=RA23-PA22&dq=industrial+research+laboratories\" target=\"_blank\">\"Putting Research to Work\"<\/a>. <i>A.E.C. Bulletin - Invention and The Engineer's Relation to It<\/i> (American Engineering Council): 22\u20139<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=lYkiAQAAMAAJ&pg=RA23-PA22&dq=industrial+research+laboratories\" target=\"_blank\">https:\/\/books.google.com\/books?id=lYkiAQAAMAAJ&pg=RA23-PA22&dq=industrial+research+laboratories<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Putting+Research+to+Work&rft.jtitle=A.E.C.+Bulletin+-+Invention+and+The+Engineer%27s+Relation+to+It&rft.aulast=Boyd%2C+T.A.&rft.au=Boyd%2C+T.A.&rft.date=May+1938&rft.pages=22%E2%80%939&rft.pub=American+Engineering+Council&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DlYkiAQAAMAAJ%26pg%3DRA23-PA22%26dq%3Dindustrial%2Bresearch%2Blaboratories&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NRCRsearch40-30\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-NRCRsearch40_30-0\">30.0<\/a><\/sup> <sup><a href=\"#cite_ref-NRCRsearch40_30-1\">30.1<\/a><\/sup> <sup><a href=\"#cite_ref-NRCRsearch40_30-2\">30.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">National Research Council (December 1940). <a rel=\"nofollow\" class=\"external text\" href=\"#34\"><i>Research\u2014A National Resource, II\u2014Industrial Research<\/i><\/a>. 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Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Research%E2%80%94A+National+Resource%2C+II%E2%80%94Industrial+Research&rft.aulast=National+Research+Council&rft.au=National+Research+Council&rft.date=December+1940&rft.pub=United+States+Government+Printing+Office&rft_id=https%3A%2F%2Fnap.nationalacademies.org%2Fread%2F20233%2Fchapter%2F4%2334&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-UsselmanResearch13-31\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-UsselmanResearch13_31-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Usselman, S.W. (11 November 2013). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/economics.yale.edu\/sites\/default\/files\/usselman_paper.pdf\" target=\"_blank\">\"Research and Development in the United States since 1900: An Interpretive History\"<\/a>. Yale University<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/economics.yale.edu\/sites\/default\/files\/usselman_paper.pdf\" target=\"_blank\">https:\/\/economics.yale.edu\/sites\/default\/files\/usselman_paper.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Research+and+Development+in+the+United+States+since+1900%3A+An+Interpretive+History&rft.atitle=&rft.aulast=Usselman%2C+S.W.&rft.au=Usselman%2C+S.W.&rft.date=11+November+2013&rft.pub=Yale+University&rft_id=https%3A%2F%2Feconomics.yale.edu%2Fsites%2Fdefault%2Ffiles%2Fusselman_paper.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WangResearch19-32\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WangResearch19_32-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/hbr.org\/2019\/02\/research-when-small-teams-are-better-than-big-ones\" target=\"_blank\">\"Research: When Small Teams Are Better Than Big Ones\"<\/a>. <i>Harvard Business Review<\/i>. 21 February 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/hbr.org\/2019\/02\/research-when-small-teams-are-better-than-big-ones\" target=\"_blank\">https:\/\/hbr.org\/2019\/02\/research-when-small-teams-are-better-than-big-ones<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 May 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Research%3A+When+Small+Teams+Are+Better+Than+Big+Ones&rft.atitle=Harvard+Business+Review&rft.date=21+February+2019&rft_id=https%3A%2F%2Fhbr.org%2F2019%2F02%2Fresearch-when-small-teams-are-better-than-big-ones&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230516214845\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 1.615 seconds\nReal time usage: 2.468 seconds\nPreprocessor visited node count: 24030\/1000000\nPost\u2010expand include size: 218171\/2097152 bytes\nTemplate argument size: 69379\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 65506\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 507.077 1 -total\n 89.42% 453.452 1 Template:Reflist\n 69.82% 354.025 32 Template:Citation\/core\n 47.58% 241.258 21 Template:Cite_journal\n 17.36% 88.038 5 Template:Cite_web\n 13.79% 69.949 6 Template:Cite_book\n 12.90% 65.425 22 Template:Date\n 10.54% 53.450 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\n 4.36% 22.111 5 Template:Citation\/identifier\n 3.82% 19.367 40 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14172-0!canonical and timestamp 20230516214845 and revision id 51993. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","96de3aa20642fa1b28c2f9ea79116b43_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/b8\/ParagonLab.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/7\/7c\/From_1800_to_1900._The_wonderful_story_of_the_century%3B_its_progress_and_achievements_%281899%29_%2814778122434%29.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/e\/ee\/CSIRO_ScienceImage_1671_CSIR_Information_Stand.jpg"],"96de3aa20642fa1b28c2f9ea79116b43_timestamp":1684275142,"fff6bb59eb24072ae3ca737e0ffb2c60_type":"article","fff6bb59eb24072ae3ca737e0ffb2c60_title":"Introduction","fff6bb59eb24072ae3ca737e0ffb2c60_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction","fff6bb59eb24072ae3ca737e0ffb2c60_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/IntroductionFrom LIMSWikiJump to navigationJump to search\nTitle: LIMS Selection Guide for Manufacturing Quality Control\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: May 2023\n\r\n\nManufacturing endeavors and quality control have a long yet twisted history together, with standards, guidelines, best practices, and regulations all shaping how the two relate to each other. Consumer safety and higher quality weren't always goals of manufacturers, but today they are vital considerations towards the final end product during a time when a single product failure could ruin a manufacturer already competing in a highly competitive environment. Maintaining compliance with standards and regulations that guide safety and quality now requires more than paper notebooks and spreadsheets, particularly when it comes to laboratory analyses associated with that compliance. Manufacturing-based laboratories are continuing to adopt information management strategies that welcome solutions such as the laboratory information management system (LIMS) into the workflow of the manufacturer and its associated labs. However, selecting the right LIMS or other informatics solution is not a straightforward task.\nThis guide broadly examines the field of manufacturing across a variety of associated industries, discussing the evolution of the manufacturing-based lab and the activities it undertakes in the pursuit of safer, higher-quality products. It will look at examples of standards and regulations that impact these labs and how laboratory informatics solutions can best be utilized to maintain compliance with those standards and regulations. It will give acquisition advice and considerations while also providing a useful user requirements document in the form of LIMSpec. By the end, the reader should have a clearer idea of the challenges that affect manufacturing-based labs and how properly acquired and implemented software solutions, like the LIMS, can have a positive impact.\nThe table of contents for LIMS Selection Guide for Manufacturing Quality Control is as follows:\n\r\n\n\n1. Introduction to manufacturing laboratories\n1.1 Manufacturing labs, then and now\n1.1.1 From apothecary to small-scale manufacturing laboratory\n1.1.2 From small-scale private manufacturing lab to larger-scale industrial manufacturing lab\n1.1.3 The rise of the industrial research lab within large-scale manufacturing, and today's manufacturing landscape<\/dd>\n1.2 Laboratory roles and activities in the industry\n1.2.1 R&D roles and activities\n1.2.2 Pre-manufacturing and manufacturing roles and activities\n1.2.3 Post-production regulation and security roles and activities\n1.2.4 Tangential laboratory work<\/dd>\n1.3 Safety and quality in manufacturing industries<\/dd>\n2. Standards and regulations affecting manufacturing labs\n2.1 Globally recognized manufacturing standards\n2.1.1 Food and beverage\n2.1.1.2 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)\n2.1.1.2 Codex Alimentarius\n2.1.1.3 Global Food Safety Initiative (GFSI)\n2.1.1.4 Hazard analysis and critical control points (HACCP)\n2.1.1.5 International Featured Standards (IFS)\n2.1.1.6 International Organization for Standardization (ISO) 22000\n2.1.1.7 Safe Quality Food (SQF) Program<\/dd>\n2.1.2 Materials\n2.1.2.1 American Society of Civil Engineers (ASCE) materials standards\n2.1.2.2 ASTM International Volume 15.04\n2.1.2.3 Canadian Standards Association (CSA) A3000 series\n2.1.2.4 International Organization for Standardization (ISO) 10993\n2.1.2.5 Metal Powder Industries Federation (MPIF) Standard 35 family<\/dd>\n2.1.3 Pharmaceutical and medical devices\n2.1.3.1 ASTM International Volume 14.01\n2.1.3.2 European Pharmacopoeia standards\n2.1.3.3 International Organization for Standardization (ISO) 10993, 13485, and 16142-2\n2.1.3.4 United States Pharmacopeia and National Formulary (USP-NF) standards<\/dd>\n2.1.4 Other industries and standards\n2.1.4.1 British Standards Institution (BSI) standards\n2.1.4.2 Global Standard's Global Organic Textile Standard (GOTS)\n2.1.4.3 International Organization for Standardization (ISO) 9001\n2.1.4.4 Underwriter Laboratories (UL) standards<\/dd><\/dd>\n2.2 Regulations and laws around the world\n2.2.1 Food and beverage\n2.2.2.1 Food Safety Act 1990 and Food Standards Act 1999 - United Kingdom\n2.2.2.2 Food Safety and Standards Act of 2006 - India\n2.2.2.3 Food Safety Law - China\n2.2.2.4 Food Sanitation Act and Food Safety Basic Act - Japan\n2.2.2.5 Food Safety Modernization Act (FSMA) and other acts - United States\n2.2.2.6 General Food Law Regulation (GFLR) - European Union\n2.2.2.7 Safe Food for Canadians Act (SFCA) - Canada<\/dd>\n2.2.2 Materials\n2.2.2.1 21 CFR Part 175 and 176 - United States\n2.2.2.2 Building Standard Law - Japan\n2.2.2.3 The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - United Kingdom\n2.2.2.4 National Environment Protection (Used Packaging Materials) Measure 2011 - Australia\n2.2.2.5 Surface Coating Materials Regulations (SOR\/2016-193) - Canada<\/dd>\n2.2.3 Pharmaceutical and medical devices\n2.2.3.1 Current Good Manufacturing Practice (cGMP) regulations - United States and other countries\n2.2.3.2 Drugs and Cosmetics Act of 1940 - India\n2.2.3.3 Food and Drugs Act - Canada\n2.2.3.4 Pharmaceutical Affairs Act (PAA) and Medical Devices Act (MDA) - South Korea\n2.2.3.5 Pharmaceutical and Medical Device Act (PMD Act) - Japan<\/dd>\n2.3.4 Other industries and regulations\n2.3.4.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP) - United States and other countries\n2.3.4.2 Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation - European Union\n2.3.4.3 Resolu\u00e7\u00e3o de diretoria colegiada - RDC n\u00ba 529 - Brazil\n2.3.4.4 Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive - European Union\n2.3.4.5 Road Vehicle Standards (RVS) legislation - Australia<\/dd><\/dd><\/dd>\n3. Choosing laboratory informatics software for your manufacturing lab\n3.1 Evaluation and selection\n3.1.1 Technology considerations\n3.1.1.1 Laboratory informatics options<\/dd>\n3.1.2 Features and functions\n3.1.2.1 Base features\n3.1.2.2 Specialty features<\/dd>\n3.1.3 Cybersecurity considerations\n3.1.4 Regulatory compliance considerations\n3.1.5 System flexibility\n3.1.6 Cost considerations<\/dd>\n3.2 Implementation\n3.2.1 Internal and external integrations<\/dd>\n3.3 MSW, updates, and other contracted services\n3.4 How a user requirements specification fits into the entire process (LIMSpec)<\/dd>\n4. Resources for selecting and implementing informatics solutions\n4.1 LIMS vendors\n4.2 Consultants\n4.3 Professional\n4.3.1 Trade organizations\n4.3.2 Conferences and trade shows<\/dd>\n4.4 LIMSpec<\/dd>\n5. Taking the next step\n5.1 Conduct initial research into a specification document tailored to your lab's needs\n5.2 Issue some of the specification as part of a request for information (RFI)\n5.3 Respond to or open dialogue with vendors\n5.3.1 The value of demonstrations<\/dd>\n5.4 Finalize the requirements specification and choose a vendor<\/dd>\n6. Closing remarks\nAppendix 1. Blank LIMSpec template for manufacturing labs\nA1. Introduction and methodology\nA2. Primary laboratory workflow\nA3. Maintaining laboratory workflow and operations\nA4. Specialty laboratory functions\nA5. Technology and performance improvements\nA6. Security and integrity of systems and operations\nA7. Putting those requirements to practical use and caveats\nA8. LIMSpec in Microsoft Word format<\/dd>\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 21:47.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 4 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","fff6bb59eb24072ae3ca737e0ffb2c60_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Introduction rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Introduction skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Battery_Manufacturing_Lab_(50954228316).jpg\" class=\"image wiki-link\" data-key=\"0277141c002e4bacfafe0813794f4630\"><img alt=\"Battery Manufacturing Lab (50954228316).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/3\/37\/Battery_Manufacturing_Lab_%2850954228316%29.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div>\n<p><b>Title<\/b>: <i>LIMS Selection Guide for Manufacturing Quality Control<\/i>\n<\/p><p><b>Edition<\/b>: First Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: May 2023\n<\/p><p><br \/>\nManufacturing endeavors and <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_control\" title=\"Quality control\" class=\"wiki-link\" data-key=\"1e0e0c2eb3e45aff02f5d61799821f0f\">quality control<\/a> have a long yet twisted history together, with standards, guidelines, best practices, and regulations all shaping how the two relate to each other. Consumer safety and higher <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_(business)\" title=\"Quality (business)\" class=\"wiki-link\" data-key=\"c4ac43430d1c3a3a15d1255257aaea37\">quality<\/a> weren't always goals of manufacturers, but today they are vital considerations towards the final end product during a time when a single product failure could ruin a manufacturer already competing in a highly competitive environment. Maintaining compliance with standards and regulations that guide safety and quality now requires more than paper notebooks and spreadsheets, particularly when it comes to <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> analyses associated with that compliance. Manufacturing-based laboratories are continuing to adopt <a href=\"https:\/\/www.limswiki.org\/index.php\/Information_management\" title=\"Information management\" class=\"wiki-link\" data-key=\"f8672d270c0750a858ed940158ca0a73\">information management<\/a> strategies that welcome solutions such as the <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS) into the <a href=\"https:\/\/www.limswiki.org\/index.php\/Workflow\" title=\"Workflow\" class=\"wiki-link\" data-key=\"92bd8748272e20d891008dcb8243e8a8\">workflow<\/a> of the manufacturer and its associated labs. However, selecting the right LIMS or other <a href=\"https:\/\/www.limswiki.org\/index.php\/Informatics_(academic_field)\" title=\"Informatics (academic field)\" class=\"wiki-link\" data-key=\"0391318826a5d9f9a1a1bcc88394739f\">informatics<\/a> solution is not a straightforward task.\n<\/p><p>This guide broadly examines the field of manufacturing across a variety of associated industries, discussing the evolution of the manufacturing-based lab and the activities it undertakes in the pursuit of safer, higher-quality products. It will look at examples of standards and regulations that impact these labs and how laboratory informatics solutions can best be utilized to maintain compliance with those standards and regulations. It will give acquisition advice and considerations while also providing a useful user requirements document in the form of LIMSpec. By the end, the reader should have a clearer idea of the challenges that affect manufacturing-based labs and how properly acquired and implemented software solutions, like the LIMS, can have a positive impact.\n<\/p><p>The table of contents for <i>LIMS Selection Guide for Manufacturing Quality Control<\/i> is as follows:\n<\/p><p><br \/>\n<\/p>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction to manufacturing laboratories\/Manufacturing labs, then and now\" class=\"wiki-link\" data-key=\"96de3aa20642fa1b28c2f9ea79116b43\">1. Introduction to manufacturing laboratories<\/a>\n<dl><dd>1.1 Manufacturing labs, then and now\n<dl><dd>1.1.1 From apothecary to small-scale manufacturing laboratory<\/dd>\n<dd>1.1.2 From small-scale private manufacturing lab to larger-scale industrial manufacturing lab<\/dd>\n<dd>1.1.3 The rise of the industrial research lab within large-scale manufacturing, and today's manufacturing landscape<\/dd><\/dl><\/dd>\n<dd>1.2 Laboratory roles and activities in the industry\n<dl><dd>1.2.1 R&D roles and activities<\/dd>\n<dd>1.2.2 Pre-manufacturing and manufacturing roles and activities<\/dd>\n<dd>1.2.3 Post-production regulation and security roles and activities<\/dd>\n<dd>1.2.4 Tangential laboratory work<\/dd><\/dl><\/dd>\n<dd>1.3 Safety and quality in manufacturing industries<\/dd><\/dl><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Standards and regulations affecting manufacturing labs\/Globally recognized manufacturing standards\" class=\"wiki-link\" data-key=\"15a608383abc44912e4e0b246caa1a92\">2. Standards and regulations affecting manufacturing labs<\/a>\n<dl><dd>2.1 Globally recognized manufacturing standards\n<dl><dd>2.1.1 Food and beverage\n<dl><dd>2.1.1.2 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)<\/dd>\n<dd>2.1.1.2 Codex Alimentarius<\/dd>\n<dd>2.1.1.3 Global Food Safety Initiative (GFSI)<\/dd>\n<dd>2.1.1.4 Hazard analysis and critical control points (HACCP)<\/dd>\n<dd>2.1.1.5 International Featured Standards (IFS)<\/dd>\n<dd>2.1.1.6 International Organization for Standardization (ISO) 22000<\/dd>\n<dd>2.1.1.7 Safe Quality Food (SQF) Program<\/dd><\/dl><\/dd>\n<dd>2.1.2 Materials\n<dl><dd>2.1.2.1 American Society of Civil Engineers (ASCE) materials standards<\/dd>\n<dd>2.1.2.2 ASTM International Volume 15.04<\/dd>\n<dd>2.1.2.3 Canadian Standards Association (CSA) A3000 series<\/dd>\n<dd>2.1.2.4 International Organization for Standardization (ISO) 10993<\/dd>\n<dd>2.1.2.5 Metal Powder Industries Federation (MPIF) Standard 35 family<\/dd><\/dl><\/dd>\n<dd>2.1.3 Pharmaceutical and medical devices\n<dl><dd>2.1.3.1 ASTM International Volume 14.01<\/dd>\n<dd>2.1.3.2 European Pharmacopoeia standards<\/dd>\n<dd>2.1.3.3 International Organization for Standardization (ISO) 10993, 13485, and 16142-2<\/dd>\n<dd>2.1.3.4 United States Pharmacopeia and National Formulary (USP-NF) standards<\/dd><\/dl><\/dd>\n<dd>2.1.4 Other industries and standards\n<dl><dd>2.1.4.1 British Standards Institution (BSI) standards<\/dd>\n<dd>2.1.4.2 Global Standard's Global Organic Textile Standard (GOTS)<\/dd>\n<dd>2.1.4.3 International Organization for Standardization (ISO) 9001<\/dd>\n<dd>2.1.4.4 Underwriter Laboratories (UL) standards<\/dd><\/dl><\/dd><\/dl><\/dd>\n<dd>2.2 Regulations and laws around the world\n<dl><dd>2.2.1 Food and beverage\n<dl><dd>2.2.2.1 Food Safety Act 1990 and Food Standards Act 1999 - United Kingdom<\/dd>\n<dd>2.2.2.2 Food Safety and Standards Act of 2006 - India<\/dd>\n<dd>2.2.2.3 Food Safety Law - China<\/dd>\n<dd>2.2.2.4 Food Sanitation Act and Food Safety Basic Act - Japan<\/dd>\n<dd>2.2.2.5 Food Safety Modernization Act (FSMA) and other acts - United States<\/dd>\n<dd>2.2.2.6 General Food Law Regulation (GFLR) - European Union<\/dd>\n<dd>2.2.2.7 Safe Food for Canadians Act (SFCA) - Canada<\/dd><\/dl><\/dd>\n<dd>2.2.2 Materials\n<dl><dd>2.2.2.1 21 CFR Part 175 and 176 - United States<\/dd>\n<dd>2.2.2.2 Building Standard Law - Japan<\/dd>\n<dd>2.2.2.3 The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - United Kingdom<\/dd>\n<dd>2.2.2.4 National Environment Protection (Used Packaging Materials) Measure 2011 - Australia<\/dd>\n<dd>2.2.2.5 Surface Coating Materials Regulations (SOR\/2016-193) - Canada<\/dd><\/dl><\/dd>\n<dd>2.2.3 Pharmaceutical and medical devices\n<dl><dd>2.2.3.1 Current Good Manufacturing Practice (cGMP) regulations - United States and other countries<\/dd>\n<dd>2.2.3.2 Drugs and Cosmetics Act of 1940 - India<\/dd>\n<dd>2.2.3.3 Food and Drugs Act - Canada<\/dd>\n<dd>2.2.3.4 Pharmaceutical Affairs Act (PAA) and Medical Devices Act (MDA) - South Korea<\/dd>\n<dd>2.2.3.5 Pharmaceutical and Medical Device Act (PMD Act) - Japan<\/dd><\/dl><\/dd>\n<dd>2.3.4 Other industries and regulations\n<dl><dd>2.3.4.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP) - United States and other countries<\/dd>\n<dd>2.3.4.2 Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation - European Union<\/dd>\n<dd>2.3.4.3 Resolu\u00e7\u00e3o de diretoria colegiada - RDC n\u00ba 529 - Brazil<\/dd>\n<dd>2.3.4.4 Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive - European Union<\/dd>\n<dd>2.3.4.5 Road Vehicle Standards (RVS) legislation - Australia<\/dd><\/dl><\/dd><\/dl><\/dd><\/dl><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Choosing laboratory informatics software for your manufacturing lab\/Evaluation and selection\" class=\"wiki-link\" data-key=\"65f78607cbccba23967db83197332e4c\">3. Choosing laboratory informatics software for your manufacturing lab<\/a>\n<dl><dd>3.1 Evaluation and selection\n<dl><dd>3.1.1 Technology considerations\n<dl><dd>3.1.1.1 Laboratory informatics options<\/dd><\/dl><\/dd>\n<dd>3.1.2 Features and functions\n<dl><dd>3.1.2.1 Base features<\/dd>\n<dd>3.1.2.2 Specialty features<\/dd><\/dl><\/dd>\n<dd>3.1.3 Cybersecurity considerations<\/dd>\n<dd>3.1.4 Regulatory compliance considerations<\/dd>\n<dd>3.1.5 System flexibility<\/dd>\n<dd>3.1.6 Cost considerations<\/dd><\/dl><\/dd>\n<dd>3.2 Implementation\n<dl><dd>3.2.1 Internal and external integrations<\/dd><\/dl><\/dd>\n<dd>3.3 MSW, updates, and other contracted services<\/dd>\n<dd>3.4 How a user requirements specification fits into the entire process (LIMSpec)<\/dd><\/dl><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Resources for selecting and implementing informatics solutions\/LIMS vendors\" class=\"wiki-link\" data-key=\"d1c053b2048cf912b5b8f8e81bfa051d\">4. Resources for selecting and implementing informatics solutions<\/a>\n<dl><dd>4.1 LIMS vendors<\/dd>\n<dd>4.2 Consultants<\/dd>\n<dd>4.3 Professional\n<dl><dd>4.3.1 Trade organizations<\/dd>\n<dd>4.3.2 Conferences and trade shows<\/dd><\/dl><\/dd>\n<dd>4.4 LIMSpec<\/dd><\/dl><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Taking the next step\/Conduct initial research into a specification document tailored to your lab's needs\" class=\"wiki-link\" data-key=\"de02f90651071c032712ced29a801111\">5. Taking the next step<\/a>\n<dl><dd>5.1 Conduct initial research into a specification document tailored to your lab's needs<\/dd>\n<dd>5.2 Issue some of the specification as part of a request for information (RFI)<\/dd>\n<dd>5.3 Respond to or open dialogue with vendors\n<dl><dd>5.3.1 The value of demonstrations<\/dd><\/dl><\/dd>\n<dd>5.4 Finalize the requirements specification and choose a vendor<\/dd><\/dl><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Closing_remarks\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Closing remarks\" class=\"wiki-link\" data-key=\"1dd67f6027a9dc8694a017571370655a\">6. Closing remarks<\/a><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Introduction_and_methodology\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Introduction and methodology\" class=\"wiki-link\" data-key=\"00a9773130372b2ddd95ad56d5c39ac7\">Appendix 1. Blank LIMSpec template for manufacturing labs<\/a>\n<dl><dd>A1. Introduction and methodology<\/dd>\n<dd>A2. Primary laboratory workflow<\/dd>\n<dd>A3. Maintaining laboratory workflow and operations<\/dd>\n<dd>A4. Specialty laboratory functions<\/dd>\n<dd>A5. Technology and performance improvements<\/dd>\n<dd>A6. Security and integrity of systems and operations<\/dd>\n<dd>A7. Putting those requirements to practical use and caveats<\/dd>\n<dd>A8. LIMSpec in Microsoft Word format<\/dd><\/dl><\/dd><\/dl>\n<p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230516221119\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.019 seconds\nReal time usage: 0.024 seconds\nPreprocessor visited node count: 1\/1000000\nPost\u2010expand include size: 0\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 1\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 0.000 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14171-0!canonical and timestamp 20230516221119 and revision id 51992. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","fff6bb59eb24072ae3ca737e0ffb2c60_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/3\/37\/Battery_Manufacturing_Lab_%2850954228316%29.jpg"],"fff6bb59eb24072ae3ca737e0ffb2c60_timestamp":1684275142,"816bc5ee048c8669f9d42b30425606b4":{"type":"chapter","title":"About this book","key":"816bc5ee048c8669f9d42b30425606b4"}},"link":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control","price_currency":"","price_amount":"","book_size":"","download_url":"https:\/\/www.limsforum.com?ebb_action=book_download&book_id=107661","language":"","cta_button_content":"","toc":[{"type":"chapter","name":"About this book","id":"816bc5ee048c8669f9d42b30425606b4","children":[{"type":"article","name":"Introduction","id":"fff6bb59eb24072ae3ca737e0ffb2c60","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction"}]},{"type":"chapter","name":"1. Introduction to manufacturing laboratories","id":"d695b86f2a0f60ac3a27d3c58505d14a","children":[{"type":"article","name":"1.1 Manufacturing labs, then and now","id":"96de3aa20642fa1b28c2f9ea79116b43","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Manufacturing_labs,_then_and_now"},{"type":"article","name":"1.2 Laboratory roles and activities in the industry","id":"f5c58bc41bd3b4f5fc4356c7aea9ef5c","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Laboratory_roles_and_activities_in_the_industry"},{"type":"article","name":"1.3 Safety and quality in manufacturing industries","id":"ffc0963fbdac2cc3102de3a80c5a93a9","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction_to_manufacturing_laboratories\/Safety_and_quality_in_manufacturing_industries"}]},{"type":"chapter","name":"2. Standards and regulations affecting manufacturing labs","id":"e0422248adaae25593847d2460b997d3","children":[{"type":"article","name":"2.1 Globally recognized manufacturing standards","id":"15a608383abc44912e4e0b246caa1a92","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Globally_recognized_manufacturing_standards"},{"type":"article","name":"2.2 Regulations and laws around the world","id":"829960d7b100216b435c1232f06318e6","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Standards_and_regulations_affecting_manufacturing_labs\/Regulations_and_laws_around_the_world"}]},{"type":"chapter","name":"3. Choosing laboratory informatics software for your manufacturing lab","id":"808d21574d7782a6a8dde5fb02c8d5e3","children":[{"type":"article","name":"3.1 Evaluation and selection","id":"65f78607cbccba23967db83197332e4c","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Evaluation_and_selection"},{"type":"article","name":"3.2 Implementation","id":"f758af407ce57d327e64934c9c51b7b4","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/Implementation"},{"type":"article","name":"3.3 MSW, updates, and other contracted services","id":"951ce542e526420f000495fb950c810e","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/MSW,_updates,_and_other_contracted_services"},{"type":"article","name":"3.4 How a user requirements specification fits into the entire process (LIMSpec)","id":"5a3c4f3a39640cce57b0d27985a4ca7a","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Choosing_laboratory_informatics_software_for_your_manufacturing_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)"}]},{"type":"chapter","name":"4. Resources for selecting and implementing informatics solutions","id":"3d2601f7d4ff73414a0dff836bc54304","children":[{"type":"article","name":"4.1 LIMS vendors","id":"d1c053b2048cf912b5b8f8e81bfa051d","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors"},{"type":"article","name":"4.2 Consultants","id":"f591d51de7768697caa251a97523982a","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/Consultants"},{"type":"article","name":"4.3 Professional","id":"c2e5e2da2eacd71ffb3abe004274bac4","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/Professional"},{"type":"article","name":"4.4 LIMSpec","id":"d3a97a2b2c8dcf637dcbc673e170382d","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec"}]},{"type":"chapter","name":"5. Taking the next step","id":"6e631ad1cc67b4757a6ae3961b7b2f08","children":[{"type":"article","name":"5.1 Conduct initial research into a specification document tailored to your lab's needs","id":"de02f90651071c032712ced29a801111","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs"},{"type":"article","name":"5.2 Issue some of the specification as part of a request for information (RFI)","id":"33d82d5dd5f85fea7ef356a3cc2dbbf0","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)"},{"type":"article","name":"5.3 Respond to or open dialogue with vendors","id":"dc2dde21cc8a46ea3112996c30b06df7","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors"},{"type":"article","name":"5.4 Finalize the requirements specification and choose a vendor","id":"46a8688154033c3e5f25ef709d80d41e","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor"}]},{"type":"chapter","name":"6. Closing remarks","id":"213ae88adeca4a9cefa2bf72d18c0797","children":[{"type":"article","name":"6.1 Closing remarks","id":"1dd67f6027a9dc8694a017571370655a","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Closing_remarks"}]},{"type":"chapter","name":"7. Appendix 1. Blank LIMSpec template for manufacturing labs","id":"265e928f7235cc717bedc2d3f228b10e","children":[{"type":"article","name":"A1. Introduction and methodology","id":"00a9773130372b2ddd95ad56d5c39ac7","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Introduction_and_methodology"},{"type":"article","name":"A2. Primary laboratory workflow","id":"5fd4fe4c2259365fa0cb3f7c8d94a926","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Primary_laboratory_workflow"},{"type":"article","name":"A3. Maintaining laboratory workflow and operations","id":"ad52877e7e3ec7923c1362f4a06f6257","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Maintaining_laboratory_workflow_and_operations"},{"type":"article","name":"A4. Specialty laboratory functions","id":"037082b7afd4f3dd9310610fbd0efc7c","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Specialty_laboratory_functions"},{"type":"article","name":"A5. Technology and performance improvements","id":"cf69a4c8871d66429a02b00b9913e6f6","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Technology_and_performance_improvements"},{"type":"article","name":"A6. Security and integrity of systems and operations","id":"8dba7922c519f23896ea896ed1a6beab","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Security_and_integrity_of_systems_and_operations"},{"type":"article","name":"A7. Putting those requirements to practical use and caveats","id":"2d050e46992605c76dc92938bd5bfd39","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use"},{"type":"article","name":"A8. LIMSpec in Microsoft Word format","id":"597876f8d548775f68f71303f49964fb","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/LIMSpec_in_Microsoft_Word_format"}]}],"settings":{"show_cover":"1","show_title":"1","show_subtitle":"0","show_full_title":"1","show_editor":"1","show_editor_pic":"1","show_publisher":"1","show_language":"1","show_size":"1","show_toc":"1","show_content_beneath_cover":"1","cta_button":"1","content_location":"1","toc_links":"disabled","log_in_msg":"<span><\/span> Please log in to read online.","cover_size":"medium"},"title_image":"https:\/\/s3.limsforum.com\/www.limsforum.com\/wp-content\/uploads\/Battery_Manufacturing_Lab_50954228316-scaled.jpg"}}
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