{"ID":105590,"post_author":"9412100","post_date":"2023-01-10 14:29:27","post_date_gmt":"0000-00-00 00:00:00","post_content":"","post_title":"LIMS Selection Guide for Food Safety and Quality","post_excerpt":"","post_status":"draft","comment_status":"closed","ping_status":"closed","post_password":"","post_name":"","to_ping":"","pinged":"","post_modified":"2023-01-10 14:29:27","post_modified_gmt":"2023-01-10 19:29:27","post_content_filtered":"","post_parent":0,"guid":"https:\/\/www.limsforum.com\/?post_type=ebook&p=105590","menu_order":0,"post_type":"ebook","post_mime_type":"","comment_count":"0","filter":"","_ebook_metadata":{"enabled":"on","private":"0","guid":"CD047DC0-0765-4E02-9F4B-40E63FE4B96E","title":"LIMS Selection Guide for Food Safety and Quality","subtitle":"First Edition","cover_theme":"nico_20","cover_image":"https:\/\/www.limsforum.com\/wp-content\/plugins\/rdp-ebook-builder\/pl\/cover.php?cover_style=nico_20&subtitle=First+Edition&editor=Shawn+Douglas&title=LIMS+Selection+Guide+for+Food+Safety+and+Quality&title_image=https%3A%2F%2Fs3.limsforum.com%2Fwww.limsforum.com%2Fwp-content%2Fuploads%2FFood-Safety-1.png&publisher=LabLynx+Press","editor":"Shawn Douglas","publisher":"LabLynx Press","author_id":"26","image_url":"","items":{"68bd688e25b4385b821b15fc1598d6c6_type":"article","68bd688e25b4385b821b15fc1598d6c6_title":"A8. LIMSpec in Microsoft Word format","68bd688e25b4385b821b15fc1598d6c6_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/LIMSpec_in_Microsoft_Word_format","68bd688e25b4385b821b15fc1598d6c6_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Blank LIMSpec template for food and beverage 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 Food and Beverage 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 food and beverage labs\nTitle: LIMS Selection Guide for Food Safety and Quality\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/LIMSpec_in_Microsoft_Word_format\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/LIMSpec_in_Microsoft_Word_format<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:27.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","68bd688e25b4385b821b15fc1598d6c6_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_labs_LIMSpec_in_Microsoft_Word_format rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_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 Food Safety and Quality\/Blank LIMSpec template for food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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_Food_and_Beverage_Labs_v1.0.docx\" title=\"File:LIMSpec for Food and Beverage Labs v1.0.docx\" class=\"wiki-link\" data-key=\"5af3519337060eab1d1338a018cf9fde\">File:LIMSpec for Food and Beverage 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 food and beverage labs\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for Food Safety and Quality<\/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>: January 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230110192739\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.008 seconds\nReal time usage: 0.009 seconds\nPreprocessor visited node count: 10\/1000000\nPost\u2010expand include size: 1708\/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% 2.466 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/LIMSpec_in_Microsoft_Word_format\n100.00% 2.466 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13950-0!canonical and timestamp 20230110192740 and revision id 50901. 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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/LIMSpec_in_Microsoft_Word_format\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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>","68bd688e25b4385b821b15fc1598d6c6_images":[],"68bd688e25b4385b821b15fc1598d6c6_timestamp":1673378973,"e8f9af0e14860993c90c8fe5e1bbdda3_type":"article","e8f9af0e14860993c90c8fe5e1bbdda3_title":"A7. Putting those requirements to practical use and caveats","e8f9af0e14860993c90c8fe5e1bbdda3_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Putting_LIMSpec_to_Use","e8f9af0e14860993c90c8fe5e1bbdda3_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Blank LIMSpec template for food and beverage 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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Putting_LIMSpec_to_Use\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Putting_LIMSpec_to_Use<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:26.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","e8f9af0e14860993c90c8fe5e1bbdda3_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_labs_Putting_LIMSpec_to_Use rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_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 Food Safety and Quality\/Blank LIMSpec template for food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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: 20230110192616\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.135 seconds\nReal time usage: 0.581 seconds\nPreprocessor visited node count: 5820\/1000000\nPost\u2010expand include size: 48143\/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: 13064\/5000000 bytes\nLua time usage: 0.020\/7 seconds\nLua virtual size: 5505024\/52428800 bytes\nLua estimated memory usage: 0 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 133.496 1 -total\n 94.71% 126.437 1 Template:Reflist\n 47.25% 63.077 1 Template:Dead_link\n 45.76% 61.094 1 Template:Fix\n 39.72% 53.031 1 Template:Category_handler\n 38.63% 51.572 8 Template:Cite_web\n 35.34% 47.176 8 Template:Citation\/core\n 7.98% 10.658 7 Template:Date\n 5.23% 6.980 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Putting_LIMSpec_to_Use\n 4.43% 5.908 1 Template:Cat_handler\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13949-0!canonical and timestamp 20230110192617 and revision id 50900. 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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Putting_LIMSpec_to_Use\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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>","e8f9af0e14860993c90c8fe5e1bbdda3_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/c\/cf\/Requirements_Allocation_Sheet.jpg"],"e8f9af0e14860993c90c8fe5e1bbdda3_timestamp":1673378973,"38b1284aaf25c5e7fc592f28df438e77_type":"article","38b1284aaf25c5e7fc592f28df438e77_title":"A6. Security and integrity of systems and operations","38b1284aaf25c5e7fc592f28df438e77_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Security_and_integrity_of_systems_and_operations","38b1284aaf25c5e7fc592f28df438e77_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Blank LIMSpec template for food and beverage 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\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\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\n\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)\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, 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\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\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 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\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\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\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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Security_and_integrity_of_systems_and_operations\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Security_and_integrity_of_systems_and_operations<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:25.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","38b1284aaf25c5e7fc592f28df438e77_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_labs_Security_and_integrity_of_systems_and_operations rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_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 Food Safety and Quality\/Blank LIMSpec template for food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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:\/\/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:\/\/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 \/>\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>\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, 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>\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:\/\/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 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:\/\/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>\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<\/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: 20230110192559\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.061 seconds\nReal time usage: 0.065 seconds\nPreprocessor visited node count: 509\/1000000\nPost\u2010expand include size: 158259\/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% 16.409 1 -total\n 78.66% 12.907 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Security_and_integrity_of_systems_and_operations\n 20.63% 3.385 1 Template:Reflist\n 11.61% 1.906 1 Template:LIMSpec\/Data_integrity\n 11.11% 1.823 1 Template:LIMSpec\/Configuration_management\n 10.07% 1.653 1 Template:LIMSpec\/System_administration\n 9.93% 1.630 1 Template:LIMSpec\/System_validation_and_commission\n 9.60% 1.575 1 Template:LIMSpec\/Cybersecurity\n 9.43% 1.548 1 Template:LIMSpec\/Information_privacy\n 8.77% 1.439 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13948-0!canonical and timestamp 20230110192601 and revision id 50899. 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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Security_and_integrity_of_systems_and_operations\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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>","38b1284aaf25c5e7fc592f28df438e77_images":[],"38b1284aaf25c5e7fc592f28df438e77_timestamp":1673378972,"b32fbbb8a3c435b4d62249bf2a390c65_type":"article","b32fbbb8a3c435b4d62249bf2a390c65_title":"A5. Technology and performance improvements","b32fbbb8a3c435b4d62249bf2a390c65_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Technology_and_performance_improvements","b32fbbb8a3c435b4d62249bf2a390c65_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Blank LIMSpec template for food and beverage 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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Technology_and_performance_improvements\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Technology_and_performance_improvements<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:25.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","b32fbbb8a3c435b4d62249bf2a390c65_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_labs_Technology_and_performance_improvements rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_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 Food Safety and Quality\/Blank LIMSpec template for food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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: 20230110192539\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.036 seconds\nReal time usage: 0.042 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% 19.066 1 -total\n 78.23% 14.915 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Technology_and_performance_improvements\n 21.31% 4.063 1 Template:Reflist\n 10.99% 2.095 1 Template:LIMSpec\/Systems_integration\n 10.81% 2.061 1 Template:LIMSpec\/Instrument_data_systems_functions\n 10.59% 2.019 1 Template:LIMSpec\/Artificial_intelligence_and_smart_systems\n 10.31% 1.965 1 Template:LIMSpec\/Lean_laboratory_and_continuous_improvement\n 10.21% 1.947 1 Template:LIMSpec\/Laboratory_scheduling_and_capacity_planning\n 8.95% 1.707 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13947-0!canonical and timestamp 20230110192541 and revision id 50898. 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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Technology_and_performance_improvements\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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>","b32fbbb8a3c435b4d62249bf2a390c65_images":[],"b32fbbb8a3c435b4d62249bf2a390c65_timestamp":1673378972,"39ba44ae86c0d28b50824500dce343b6_type":"article","39ba44ae86c0d28b50824500dce343b6_title":"A4. Specialty laboratory functions","39ba44ae86c0d28b50824500dce343b6_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Specialty_laboratory_functions","39ba44ae86c0d28b50824500dce343b6_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Blank LIMSpec template for food and beverage 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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Specialty_laboratory_functions\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Specialty_laboratory_functions<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:25.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","39ba44ae86c0d28b50824500dce343b6_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_labs_Specialty_laboratory_functions rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_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 Food Safety and Quality\/Blank LIMSpec template for food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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: 20230110192520\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.041 seconds\nReal time usage: 0.046 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% 15.113 1 -total\n 75.25% 11.373 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Specialty_laboratory_functions\n 24.26% 3.666 1 Template:Reflist\n 13.68% 2.067 1 Template:LIMSpec\/Production_management\n 12.38% 1.871 1 Template:LIMSpec\/Agriculture_and_food_data_management\n 12.33% 1.863 1 Template:LIMSpec\/Statistical_trending_and_control_charts\n 12.27% 1.854 1 Template:LIMSpec\/Scientific_data_management\n 10.36% 1.566 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13946-0!canonical and timestamp 20230110192522 and revision id 50897. 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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Specialty_laboratory_functions\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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>","39ba44ae86c0d28b50824500dce343b6_images":[],"39ba44ae86c0d28b50824500dce343b6_timestamp":1673378972,"5caff53b14646908445e721d9a740cee_type":"article","5caff53b14646908445e721d9a740cee_title":"A3. Maintaining laboratory workflow and operations","5caff53b14646908445e721d9a740cee_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Maintaining_laboratory_workflow_and_operations","5caff53b14646908445e721d9a740cee_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Blank LIMSpec template for food and beverage 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\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\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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Maintaining_laboratory_workflow_and_operations\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Maintaining_laboratory_workflow_and_operations<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:24.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","5caff53b14646908445e721d9a740cee_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_labs_Maintaining_laboratory_workflow_and_operations rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_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 Food Safety and Quality\/Blank LIMSpec template for food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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:\/\/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>\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: 20230110192459\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.104 seconds\nReal time usage: 0.110 seconds\nPreprocessor visited node count: 1053\/1000000\nPost\u2010expand include size: 285613\/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% 23.709 1 -total\n 84.99% 20.150 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Maintaining_laboratory_workflow_and_operations\n 14.23% 3.373 1 Template:Reflist\n 8.17% 1.936 1 Template:LIMSpec\/Document_management\n 7.17% 1.700 1 Template:LIMSpec\/Resource_management\n 7.01% 1.662 1 Template:LIMSpec\/Instrument_and_equipment_management\n 6.94% 1.645 1 Template:LIMSpec\/Investigation_and_quality_management\n 6.89% 1.633 1 Template:LIMSpec\/Compliance_management\n 6.60% 1.566 1 Template:LIMSpec\/Standard_and_reagent_management\n 6.54% 1.550 1 Template:LIMSpec\/Scheduled_event_management\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13945-0!canonical and timestamp 20230110192500 and revision id 50896. 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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Maintaining_laboratory_workflow_and_operations\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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>","5caff53b14646908445e721d9a740cee_images":[],"5caff53b14646908445e721d9a740cee_timestamp":1673378972,"db91cfa812915dc86f5738f70bf0098f_type":"article","db91cfa812915dc86f5738f70bf0098f_title":"A2. Primary laboratory workflow","db91cfa812915dc86f5738f70bf0098f_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Primary_laboratory_workflow","db91cfa812915dc86f5738f70bf0098f_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Blank LIMSpec template for food and beverage 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\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\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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Primary_laboratory_workflow\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Primary_laboratory_workflow<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:24.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","db91cfa812915dc86f5738f70bf0098f_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_labs_Primary_laboratory_workflow rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_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 Food Safety and Quality\/Blank LIMSpec template for food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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:\/\/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:\/\/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: 20230110192438\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.061 seconds\nReal time usage: 0.069 seconds\nPreprocessor visited node count: 514\/1000000\nPost\u2010expand include size: 155669\/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% 19.896 1 -total\n 80.75% 16.067 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Primary_laboratory_workflow\n 18.87% 3.755 1 Template:Reflist\n 10.55% 2.098 1 Template:LIMSpec\/Sample_and_experiment_registration\n 9.61% 1.912 1 Template:LIMSpec\/Reporting\n 9.57% 1.903 1 Template:LIMSpec\/Sample_management\n 9.43% 1.877 1 Template:LIMSpec\/Results_review_and_verification\n 9.31% 1.852 1 Template:LIMSpec\/Core_laboratory_testing_and_experiments\n 8.99% 1.788 1 Template:LIMSpec\/Sample,_experiment,_and_study_approval_and_verification\n 8.11% 1.614 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13944-0!canonical and timestamp 20230110192444 and revision id 50895. 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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Primary_laboratory_workflow\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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>","db91cfa812915dc86f5738f70bf0098f_images":[],"db91cfa812915dc86f5738f70bf0098f_timestamp":1673378972,"00d6be3534583868d1ee1319a770caf1_type":"article","00d6be3534583868d1ee1319a770caf1_title":"A1. Introduction and methodology","00d6be3534583868d1ee1319a770caf1_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Introduction_and_methodology","00d6be3534583868d1ee1319a770caf1_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Blank LIMSpec template for food and beverage 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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Introduction_and_methodology\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Introduction_and_methodology<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:24.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","00d6be3534583868d1ee1319a770caf1_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_labs_Introduction_and_methodology rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Blank_LIMSpec_template_for_food_and_beverage_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 Food Safety and Quality\/Blank LIMSpec template for food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230110192408\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.111 seconds\nReal time usage: 0.118 seconds\nPreprocessor visited node count: 6296\/1000000\nPost\u2010expand include size: 137839\/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: 14694\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 83.429 1 -total\n 89.37% 74.559 1 Template:Reflist\n 67.75% 56.524 9 Template:Citation\/core\n 57.29% 47.798 7 Template:Cite_web\n 20.70% 17.271 2 Template:Cite_journal\n 10.83% 9.038 6 Template:Date\n 10.54% 8.791 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Introduction_and_methodology\n 8.28% 6.909 1 Template:LIMSpec\/Introduction_and_methodology\n 6.83% 5.697 2 Template:Citation\/identifier\n 5.07% 4.227 14 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13943-0!canonical and timestamp 20230110192408 and revision id 50894. 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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Introduction_and_methodology\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_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>","00d6be3534583868d1ee1319a770caf1_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/9\/9b\/Systems_Requirement_Analysis.jpg"],"00d6be3534583868d1ee1319a770caf1_timestamp":1673378972,"7b322bd7ed0b3f89e1f75dc9f1cb6229_type":"article","7b322bd7ed0b3f89e1f75dc9f1cb6229_title":"6.1 Recap and closing","7b322bd7ed0b3f89e1f75dc9f1cb6229_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Closing_remarks","7b322bd7ed0b3f89e1f75dc9f1cb6229_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Closing remarksFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 6. Closing remarks \n2 References \n3 Citation information for this chapter \n\n\n\n6. Closing remarks \nThe food and beverage industry is similar to other industries in that a product is grown, developed, or processed and distributed to consumers who desire the product. However, the food and beverage industry is, well, vital to humanity, just as the agriculture industry is: we need safe, quality foods and beverages to maintain our existence. The focus on safety and quality was not always there, but with expanding scientific understanding and a realization that contaminated food and water systems were killing people, standards and regulations came into existence. With those standards and regulations came the necessary enforcement bodies, like the U.S. Food and Drug Administration (FDA) and the Food Safety Commission of Japan. And from that came the need for laboratory analyses to better meet those standards and regulations. As the food and beverage system became more complex, a need for more automated computer systems became apparent, and solutions like the laboratory information management system (LIMS) and laboratory execution system (LES) began filling the gaps.\nToday, the LIMS and other informatics solutions are increasingly important to food and beverage producers, as well as safety inspectors and third-party labs serving the industry. However, a generic LIMS won't do. This guide has highlighted that fact and identified what base and specialty characteristics such a LIMS requires in order for food and beverage labs to gain the strongest advantage in meeting their safety and quality goals. But selecting a LIMS isn't only about having the best features; concerns about cybersecurity, regulatory compliance, system flexibility, and cost, as well as a need for a robust user requirements specification (URS) must be addressed. Various chapters of this guide have addressed these concerns and needs, while also offering a well-researched, robust URS in the form of LIMSpec to food and beverage laboratories seeking a LIMS. Built on more than 130 standards, regulations, and guidance documents, the LIMSpec for food and beverage labs gives prospective LIMS buyers an additional tool in their search for a LIMS to improve the food safety and quality goals of their organization.\nFinally, this guide has provided other helpful resources towards LIMS selection, including a list of LIMS vendors and consultants, as well as related professional associations and trade events that may provide further insight into the industry and its demands. Other aspects such as maintenance, support, and warranty (MSW); requests for information (RFIs); and the software demonstration have been addressed, rounding out this guide's goal of helping you select the best LIMS for your food and beverage lab.\n\nReferences \n\n\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 Food Safety and Quality\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 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_Food_Safety_and_Quality\/Closing_remarks\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Closing_remarks<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:23.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","7b322bd7ed0b3f89e1f75dc9f1cb6229_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Closing_remarks rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_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 Food Safety and Quality\/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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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:FDA_Center_for_Food_Safety_%26_Applied_Nutrition_(CFSAN)_6565_(8754816839).jpg\" class=\"image wiki-link\" data-key=\"26835886b91e7c8fbae87d77dd093775\"><img alt=\"FDA Center for Food Safety & Applied Nutrition (CFSAN) 6565 (8754816839).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/b4\/FDA_Center_for_Food_Safety_%26_Applied_Nutrition_%28CFSAN%29_6565_%288754816839%29.jpg\" decoding=\"async\" width=\"180\" height=\"271\" \/><\/a><\/div><p>The food and beverage industry is similar to other industries in that a product is grown, developed, or processed and distributed to consumers who desire the product. However, the food and beverage industry is, well, vital to humanity, just as the agriculture industry is: we need safe, quality foods and beverages to maintain our existence. The focus on safety and <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_(business)\" title=\"Quality (business)\" class=\"wiki-link\" data-key=\"c4ac43430d1c3a3a15d1255257aaea37\">quality<\/a> was not always there, but with expanding scientific understanding and a realization that contaminated food and water systems were killing people, standards and regulations came into existence. With those standards and regulations came the necessary enforcement bodies, like the <a href=\"https:\/\/www.limswiki.org\/index.php\/Food_and_Drug_Administration\" title=\"Food and Drug Administration\" class=\"wiki-link\" data-key=\"e2be8927071ac419c0929f7aa1ede7fe\">U.S. Food and Drug Administration<\/a> (FDA) and the Food Safety Commission of Japan. And from that came the need for <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> analyses to better meet those standards and regulations. As the food and beverage system became more complex, a need for more automated computer systems became apparent, and solutions like 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) and <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) began filling the gaps.\n<\/p><p>Today, the LIMS and other <a href=\"https:\/\/www.limswiki.org\/index.php\/Informatics_(academic_field)\" title=\"Informatics (academic field)\" class=\"wiki-link\" data-key=\"0391318826a5d9f9a1a1bcc88394739f\">informatics<\/a> solutions are increasingly important to food and beverage producers, as well as safety inspectors and third-party labs serving the industry. However, a generic LIMS won't do. This guide has highlighted that fact and identified what base and specialty characteristics such a LIMS requires in order for food and beverage labs to gain the strongest advantage in meeting their safety and quality goals. But selecting a LIMS isn't only about having the best features; concerns about <a href=\"https:\/\/www.limswiki.org\/index.php\/Cybersecurity\" class=\"mw-redirect wiki-link\" title=\"Cybersecurity\" data-key=\"ba653dc2a1384e5f9f6ac9dc1a740109\">cybersecurity<\/a>, <a href=\"https:\/\/www.limswiki.org\/index.php\/Regulatory_compliance\" title=\"Regulatory compliance\" class=\"wiki-link\" data-key=\"7dbc9be278a8efda25a4b592ee6ef0ca\">regulatory compliance<\/a>, system flexibility, and cost, as well as a need for a robust user requirements specification (URS) must be addressed. Various chapters of this guide have addressed these concerns and needs, while also offering a well-researched, robust URS in the form of LIMSpec to food and beverage laboratories seeking a LIMS. Built on more than 130 standards, regulations, and guidance documents, the LIMSpec for food and beverage labs gives prospective LIMS buyers an additional tool in their search for a LIMS to improve the food safety and quality goals of their organization.\n<\/p><p>Finally, this guide has provided other helpful resources towards LIMS selection, including a list of LIMS vendors and consultants, as well as related professional associations and trade events that may provide further insight into the industry and its demands. Other aspects such as maintenance, support, and warranty (MSW); requests for information (RFIs); and the software demonstration have been addressed, rounding out this guide's goal of helping you select the best LIMS for your food and beverage lab.\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_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Introduction_and_methodology\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Blank LIMSpec template for food and beverage labs\/Introduction and methodology\" class=\"wiki-link\" data-key=\"00d6be3534583868d1ee1319a770caf1\">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 Food Safety and Quality<\/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>: January 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230110192427\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.014 seconds\nReal time usage: 0.018 seconds\nPreprocessor visited node count: 58\/1000000\nPost\u2010expand include size: 3503\/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% 7.246 1 -total\n 55.16% 3.997 1 Template:Reflist\n 41.57% 3.012 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Closing_remarks\n 22.97% 1.664 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13942-0!canonical and timestamp 20230110192427 and revision id 50893. 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_Food_Safety_and_Quality\/Closing_remarks\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/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>","7b322bd7ed0b3f89e1f75dc9f1cb6229_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/b4\/FDA_Center_for_Food_Safety_%26_Applied_Nutrition_%28CFSAN%29_6565_%288754816839%29.jpg"],"7b322bd7ed0b3f89e1f75dc9f1cb6229_timestamp":1673378972,"2db9c11a390ff38350adddca69c67fdd_type":"article","2db9c11a390ff38350adddca69c67fdd_title":"5.4 Finalize the requirements specification and choose a vendor","2db9c11a390ff38350adddca69c67fdd_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor","2db9c11a390ff38350adddca69c67fdd_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/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 food and beverage 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 Food Safety and Quality\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 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_Food_Safety_and_Quality\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:21.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","2db9c11a390ff38350adddca69c67fdd_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Taking_the_next_step_Finalize_the_requirements_specification_and_choose_a_vendor rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_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 Food Safety and Quality\/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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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 food and beverage 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_Food_Safety_and_Quality\/Closing_remarks\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Closing remarks\" class=\"wiki-link\" data-key=\"7b322bd7ed0b3f89e1f75dc9f1cb6229\">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 Food Safety and Quality<\/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>: January 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230110192427\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.008 seconds\nReal time usage: 0.011 seconds\nPreprocessor visited node count: 57\/1000000\nPost\u2010expand include size: 3588\/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% 6.201 1 -total\n 64.91% 4.025 1 Template:Reflist\n 33.85% 2.099 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor\n 27.35% 1.696 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13941-0!canonical and timestamp 20230110192427 and revision id 50892. 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_Food_Safety_and_Quality\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/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>","2db9c11a390ff38350adddca69c67fdd_images":[],"2db9c11a390ff38350adddca69c67fdd_timestamp":1673378971,"b5678217484c5c925b559de16b5f304d_type":"article","b5678217484c5c925b559de16b5f304d_title":"5.3 Respond to or open dialogue with vendors","b5678217484c5c925b559de16b5f304d_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors","b5678217484c5c925b559de16b5f304d_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/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 food and beverage 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 food and beverage 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_Food_Safety_and_Quality\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:20.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","b5678217484c5c925b559de16b5f304d_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Taking_the_next_step_Respond_to_or_open_dialogue_with_vendors rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_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 Food Safety and Quality\/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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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 food and beverage 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 food and beverage 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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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: 20230110192014\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.059 seconds\nReal time usage: 0.065 seconds\nPreprocessor visited node count: 3539\/1000000\nPost\u2010expand include size: 31951\/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: 7334\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 53.447 1 -total\n 89.25% 47.701 1 Template:Reflist\n 60.56% 32.370 4 Template:Cite_web\n 60.42% 32.294 5 Template:Citation\/core\n 13.74% 7.342 1 Template:Cite_journal\n 13.46% 7.194 4 Template:Date\n 10.62% 5.674 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\n 5.34% 2.852 8 Template:Citation\/make_link\n 2.98% 1.592 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13940-0!canonical and timestamp 20230110192016 and revision id 50891. 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_Food_Safety_and_Quality\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/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>","b5678217484c5c925b559de16b5f304d_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/55\/ForUM_demo_%282659615090%29.jpg"],"b5678217484c5c925b559de16b5f304d_timestamp":1673378971,"ec8c05877df5b9b8214a1ffbc6a0786d_type":"article","ec8c05877df5b9b8214a1ffbc6a0786d_title":"5.2 Issue some of the specification as part of a request for information (RFI)","ec8c05877df5b9b8214a1ffbc6a0786d_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)","ec8c05877df5b9b8214a1ffbc6a0786d_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/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 food and beverage 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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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 inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:19.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","ec8c05877df5b9b8214a1ffbc6a0786d_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Taking_the_next_step_Issue_some_of_the_specification_as_part_of_a_request_for_information_RFI rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_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 Food Safety and Quality\/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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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 food and beverage 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_Food_Safety_and_Quality\/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: 20230110191951\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.025 seconds\nReal time usage: 0.032 seconds\nPreprocessor visited node count: 677\/1000000\nPost\u2010expand include size: 11003\/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: 1930\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 27.879 1 -total\n 71.32% 19.882 1 Template:Reflist\n 51.74% 14.424 1 Template:Cite_web\n 39.72% 11.073 1 Template:Citation\/core\n 28.41% 7.919 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\n 7.49% 2.088 2 Template:Citation\/make_link\n 6.29% 1.754 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13939-0!canonical and timestamp 20230110191952 and revision id 50890. 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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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>","ec8c05877df5b9b8214a1ffbc6a0786d_images":[],"ec8c05877df5b9b8214a1ffbc6a0786d_timestamp":1673378971,"4d7cd16b7d897aa048577bae7dba6366_type":"article","4d7cd16b7d897aa048577bae7dba6366_title":"5.1 Conduct initial research into a specification document tailored to your lab's needs","4d7cd16b7d897aa048577bae7dba6366_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs","4d7cd16b7d897aa048577bae7dba6366_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/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 food and beverage 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 food and beverage 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 food and beverage 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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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 inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:19.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","4d7cd16b7d897aa048577bae7dba6366_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Taking_the_next_step_Conduct_initial_research_into_a_specification_document_tailored_to_your_lab_s_needs rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_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 Food Safety and Quality\/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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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 food and beverage <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 food and beverage 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 food and beverage 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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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: 20230110191900\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.076 seconds\nReal time usage: 0.086 seconds\nPreprocessor visited node count: 2784\/1000000\nPost\u2010expand include size: 25753\/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: 6589\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 71.872 1 -total\n 85.38% 61.363 1 Template:Reflist\n 60.54% 43.513 4 Template:Citation\/core\n 36.45% 26.198 3 Template:Cite_web\n 35.92% 25.816 1 Template:Cite_journal\n 14.49% 10.414 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab's_needs\n 9.50% 6.826 1 Template:Citation\/identifier\n 8.77% 6.306 2 Template:Date\n 4.58% 3.291 7 Template:Citation\/make_link\n 2.68% 1.927 1 Template:Only_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13938-0!canonical and timestamp 20230110191902 and revision id 50889. 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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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>","4d7cd16b7d897aa048577bae7dba6366_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/3\/3c\/Specification_leading_to_Design_Documents.jpg"],"4d7cd16b7d897aa048577bae7dba6366_timestamp":1673378971,"4bc6ec7c96895f5613ffc0594e209ce2_type":"article","4bc6ec7c96895f5613ffc0594e209ce2_title":"4.4 LIMSpec","4bc6ec7c96895f5613ffc0594e209ce2_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec","4bc6ec7c96895f5613ffc0594e209ce2_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/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 Food Safety and Quality\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 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_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:17.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","4bc6ec7c96895f5613ffc0594e209ce2_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Resources_for_selecting_and_implementing_informatics_solutions_LIMSpec rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_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 Food Safety and Quality\/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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/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_Food_Safety_and_Quality\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Taking the next step\/Conduct initial research into a specification document tailored to your lab's needs\" class=\"wiki-link\" data-key=\"4d7cd16b7d897aa048577bae7dba6366\">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 Food Safety and Quality<\/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>: January 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230110192026\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.058 seconds\nReal time usage: 0.063 seconds\nPreprocessor visited node count: 3457\/1000000\nPost\u2010expand include size: 27658\/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: 7931\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 52.572 1 -total\n 91.73% 48.224 1 Template:Reflist\n 66.94% 35.189 5 Template:Citation\/core\n 44.62% 23.458 4 Template:Cite_web\n 34.65% 18.217 1 Template:Cite_journal\n 9.89% 5.202 3 Template:Date\n 9.63% 5.063 1 Template:Citation\/identifier\n 8.13% 4.276 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\n 5.07% 2.666 8 Template:Citation\/make_link\n 2.88% 1.515 2 Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13937-0!canonical and timestamp 20230110192026 and revision id 50888. 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_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/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>","4bc6ec7c96895f5613ffc0594e209ce2_images":["https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/9\/97\/LIMSpec.png"],"4bc6ec7c96895f5613ffc0594e209ce2_timestamp":1673378971,"b5f21c96d22edbed3dd48104bb1e20fe_type":"article","b5f21c96d22edbed3dd48104bb1e20fe_title":"4.3 Professional","b5f21c96d22edbed3dd48104bb1e20fe_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/Professional","b5f21c96d22edbed3dd48104bb1e20fe_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/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 \nAmerican Association of Meat Processors (AAMP)\nAmerican Dairy Products Institute (ADPI)\nAmerican Dairy Science Association (ADSA)\nAmerican Institute of Baking (AIB) International\nAmerican Meat Science Association (AMSA)\nAmerican Society of Brewing Chemists (ASBC)\nAssociation for Dressings and Sauces (ADS)\nAssociation of Food and Drug Officials (AFDO)\nAssociation of Food Industries (AFI)\nAssociation of Fruit and Vegetable Inspection (AFVISA)\nCan Manufacturers Institute (CMI)\nCanadian Institute of Food Science and Technology (CIFST)\nCereals & Grains Association\nConsumer Brands Association (CBA)\nFood Northwest\nFood Producers of Canada (FPC)\nInstitute of Food Technologists (IFT)\nInternational Association for Food Protection (IAFP)\nInternational Dairy Foods Association (IDFA)\nInternational Food Information Council (IFIC)\nMidwest Food Products Association (MWFPA)\nNational Association of Flavors and Food-Ingredient Systems (NAFFS)\nNational Food Processors Association (NFPA)\nNational Protein and Food Distributors Association (NPFDA)\nNational Sanitation Foundation (NSF)\nNational Seasoning Manufacturers Association (NSMA)\nOntario Food Protection Association (OFPA)\nPeanut and Tree Nut Processors Association (PTNPA)\nPennsylvania Association for Food Protection (PAFP)\nPrivate Label Manufacturers Association (PLMA)\nRefrigerated Foods Association (RFA)\nResearch & Development Associates For Military Food & Packaging Systems (R&DA)\nWheat Quality Council\n4.3.2 Conferences and trade shows \nAmerican Food Manufacturing Summit\nAmerican Food Sure Summit\nCanadian Summit on Food Safety\nConference for Food Protection\nConsumer Food Safety Education Conference\ndrinktec\nExtractables and Leachables USA\nFood Allergy Forum\nFood Microbiology\nFood Safety Consortium\nFood Safety, Risk and Compliance Conference\nFood Safety Summit\nFoodMicro\nFOODSIM\nFuture Food-Tech Summit\nGFSI Conference\nIAFP European Symposium on Food Safety\nInternational Conference on Predictive Modelling in Food\nInternational Production & Processing Expo\nInternational Symposium on Food Packaging\nIUFoST World Congress of Food Science and Technology\nNACS Food Safety Conference\nNorth American Food Safety & Quality\nPAFP Conference\nProcess Expo\nThe Food Safety Conference\nVonlanthen Food Safety & Quality Summit\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_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/Professional\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/Professional<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:16.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","b5f21c96d22edbed3dd48104bb1e20fe_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Resources_for_selecting_and_implementing_informatics_solutions_Professional rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_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 Food Safety and Quality\/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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aamp.com\/\" target=\"_blank\">American Association of Meat Processors (AAMP)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.adpi.org\/\" target=\"_blank\">American Dairy Products Institute (ADPI)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.adsa.org\/\" target=\"_blank\">American Dairy Science Association (ADSA)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aibinternational.com\/\" target=\"_blank\">American Institute of Baking (AIB) International<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/meatscience.org\/\" target=\"_blank\">American Meat Science Association (AMSA)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.asbcnet.org\/Pages\/default.aspx\" target=\"_blank\">American Society of Brewing Chemists (ASBC)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dressings-sauces.org\/\" target=\"_blank\">Association for Dressings and Sauces (ADS)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.afdo.org\/\" target=\"_blank\">Association of Food and Drug Officials (AFDO)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.afius.org\/\" target=\"_blank\">Association of Food Industries (AFI)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.afvisa.org\/\" target=\"_blank\">Association of Fruit and Vegetable Inspection (AFVISA)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cancentral.com\/\" target=\"_blank\">Can Manufacturers Institute (CMI)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cifst.ca\/\" target=\"_blank\">Canadian Institute of Food Science and Technology (CIFST)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cerealsgrains.org\/Pages\/default.aspx\" target=\"_blank\">Cereals & Grains Association<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/consumerbrandsassociation.org\/\" target=\"_blank\">Consumer Brands Association (CBA)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.foodnorthwest.org\/\" target=\"_blank\">Food Northwest<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/foodproducersofcanada.ca\/\" target=\"_blank\">Food Producers of Canada (FPC)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ift.org\/\" target=\"_blank\">Institute of Food Technologists (IFT)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.foodprotection.org\/\" target=\"_blank\">International Association for Food Protection (IAFP)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.idfa.org\/\" target=\"_blank\">International Dairy Foods Association (IDFA)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ific.org\/\" target=\"_blank\">International Food Information Council (IFIC)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mwfpa.org\/\" target=\"_blank\">Midwest Food Products Association (MWFPA)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.naffs.org\/\" target=\"_blank\">National Association of Flavors and Food-Ingredient Systems (NAFFS)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nfpa-food.org\/\" target=\"_blank\">National Food Processors Association (NFPA)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.npfda.org\/\" target=\"_blank\">National Protein and Food Distributors Association (NPFDA)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nsf.org\/\" target=\"_blank\">National Sanitation Foundation (NSF)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/seasoningmanufacturers.org\/\" target=\"_blank\">National Seasoning Manufacturers Association (NSMA)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ofpa.on.ca\/\" target=\"_blank\">Ontario Food Protection Association (OFPA)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ptnpa.org\/default.aspx\" target=\"_blank\">Peanut and Tree Nut Processors Association (PTNPA)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pafoodprotection.com\/\" target=\"_blank\">Pennsylvania Association for Food Protection (PAFP)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.plma.com\/\" target=\"_blank\">Private Label Manufacturers Association (PLMA)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.refrigeratedfoods.org\/\" target=\"_blank\">Refrigerated Foods Association (RFA)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.militaryfood.org\/\" target=\"_blank\">Research & Development Associates For Military Food & Packaging Systems (R&DA)<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.wheatqualitycouncil.org\/\" target=\"_blank\">Wheat Quality Council<\/a><\/li><\/ul>\n<h4><span class=\"mw-headline\" id=\"4.3.2_Conferences_and_trade_shows\">4.3.2 Conferences and trade shows<\/span><\/h4>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/foodmansummit.com\/\" target=\"_blank\">American Food Manufacturing Summit<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.americanfoodsure.com\/\" target=\"_blank\">American Food Sure Summit<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.foodsafetycanada.com\/\" target=\"_blank\">Canadian Summit on Food Safety<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.foodprotect.org\/\" target=\"_blank\">Conference for Food Protection<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cfsec.org\/\" target=\"_blank\">Consumer Food Safety Education Conference<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/drinktec.com\/en\/\" target=\"_blank\">drinktec<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.eandl-conference.com\/extractables-and-leachables-usa\" target=\"_blank\">Extractables and Leachables USA<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/foodallergyforum.org\/\" target=\"_blank\">Food Allergy Forum<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/foodmicrobiology.foodtechconferences.com\/\" target=\"_blank\">Food Microbiology<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/foodsafetyconsortium.org\/\" target=\"_blank\">Food Safety Consortium<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.brightstar.co.nz\/events\/food-safety-risk-and-compliance-conference\" target=\"_blank\">Food Safety, Risk and Compliance Conference<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.food-safety.com\/food-safety-summit\" target=\"_blank\">Food Safety Summit<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/icfmh.org\/en\/activities\/foodmicro\" target=\"_blank\">FoodMicro<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.eurosis.org\/cms\/index.php?q=taxonomy\/term\/23\" target=\"_blank\">FOODSIM<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/futurefoodtechsf.com\/\" target=\"_blank\">Future Food-Tech Summit<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/events\/gfsi-conference\/?utm_source=mailchimp&utm_medium=email&utm_campaign=2023-gfsc-three-reasons\" target=\"_blank\">GFSI Conference<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.foodprotection.org\/europeansymposium\/\" target=\"_blank\">IAFP European Symposium on Food Safety<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ec-pro.co.jp\/ICPMF12\/welcome.html\" target=\"_blank\">International Conference on Predictive Modelling in Food<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ippexpo.org\/\" target=\"_blank\">International Production & Processing Expo<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ilsi.eu\/events\/upcoming-events\/\" target=\"_blank\">International Symposium on Food Packaging<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/iufost2024-italy.com\/\" target=\"_blank\">IUFoST World Congress of Food Science and Technology<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nacsshow.com\/Sessions\/Pre-Conference-Workshops\/Food-Safety-Conference\" target=\"_blank\">NACS Food Safety Conference<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/foodsafetyna.com\/\" target=\"_blank\">North American Food Safety & Quality<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pafoodprotection.com\/2023-conference\" target=\"_blank\">PAFP Conference<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/process-expo.us.messefrankfurt.com\/us\/en.html\" target=\"_blank\">Process Expo<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/newfood.events\/the-food-safety-conference-2022\/\" target=\"_blank\">The Food Safety Conference<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.vonlanthenevents.com\/en\/4th-food-safety-quality-summit\" target=\"_blank\">Vonlanthen Food Safety & Quality Summit<\/a><\/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: 20230110191630\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.013 seconds\nReal time usage: 0.017 seconds\nPreprocessor visited node count: 52\/1000000\nPost\u2010expand include size: 5318\/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% 8.764 1 -total\n 51.68% 4.529 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/Professional\n 47.32% 4.147 1 Template:Reflist\n 19.61% 1.719 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13936-0!canonical and timestamp 20230110191631 and revision id 50887. 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_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/Professional\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/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>","b5f21c96d22edbed3dd48104bb1e20fe_images":[],"b5f21c96d22edbed3dd48104bb1e20fe_timestamp":1673378971,"f217eb3dd3e8aa5d58e3a21cebb43dc2_type":"article","f217eb3dd3e8aa5d58e3a21cebb43dc2_title":"4.2 Consultants","f217eb3dd3e8aa5d58e3a21cebb43dc2_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/Consultants","f217eb3dd3e8aa5d58e3a21cebb43dc2_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/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. Entities with logos represent sponsors of LIMSwiki and LIMSforum. (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_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/Consultants\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/Consultants<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:16.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","f217eb3dd3e8aa5d58e3a21cebb43dc2_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Resources_for_selecting_and_implementing_informatics_solutions_Consultants rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_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 Food Safety and Quality\/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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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. Entities with logos represent sponsors of LIMSwiki and LIMSforum. (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: 20230110191611\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.025 seconds\nReal time usage: 0.029 seconds\nPreprocessor visited node count: 79\/1000000\nPost\u2010expand include size: 34540\/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% 10.923 1 -total\n 62.88% 6.868 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/Consultants\n 36.44% 3.980 1 Template:Reflist\n 25.08% 2.739 1 Template:LIMS,_LIS,_and_laboratory\n 15.65% 1.709 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13935-0!canonical and timestamp 20230110191612 and revision id 50886. 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_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/Consultants\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/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>","f217eb3dd3e8aa5d58e3a21cebb43dc2_images":[],"f217eb3dd3e8aa5d58e3a21cebb43dc2_timestamp":1673378971,"13e646a1466068f9c15573c3a34ab4fd_type":"article","13e646a1466068f9c15573c3a34ab4fd_title":"4.1 LIMS vendors","13e646a1466068f9c15573c3a34ab4fd_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors","13e646a1466068f9c15573c3a34ab4fd_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/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 the food and beverage industry, see the listing of food and beverage LIMS vendors.\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\" with 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\nBenchling, Inc.\n\nBenchling Notebook\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\nAll but Enterprise pricing made public.\n\n \n\n\nBentley Systems, Inc.\n\nKeyLAB\n\nNo\n\nUnited States\n\n\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 and 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\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, Azenta Lifecycle\r\nManagement Platform\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\nWinPath Enterprise\n\nNo\n\nUnited Kingdom\n\n\n\n\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\nCommon Cents Systems, Inc.\n\nApolloLIMS\n\nYes\n\nUnited States\n\n\n\nFormerly marketed Cirrus and M\/LAB as preceding products\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.[7]\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.[8][9]\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\nPricing and demonstration 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.[10]\n\n \n\n\nHM-Software\n\nHM-LAB\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nHORIZON Lab Systems, LLC\n\nHORIZON LIMS\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\nFormerly ChemWare, Inc.\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.[11]\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\n\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.[12]\n\n \n\n\nINTEGRIS LIMS GmbH\n\niLIMS\n\nNo\n\nGermany\n\n\n\nChanged company name from CSS LIMS GmbH in March 2017.[13]\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.[14]\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\nJunction Concepts, Inc.\n\nQBench\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nJusticeTrax, Inc.\n\nLIMS-plus\n\nNo\n\nUnited States\n\nPricing and Demonstration videos\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\nDemonstration 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, CannaQA, webLIMS\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.[15]\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\nLab-i, CLab-i\n\nNo\n\nSouth Africa\n\n\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, with \"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\nUnited States\n\n\n\nAcquired from Agilent.[16]\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 and demonstration videos\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\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.[17][18]\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.[19] C5 LIMS was renamed to\r\n\"LABVANTAGE Medical Suite\" in December 2012.[20] 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.[21][22]\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\nSunquest Information Systems, Inc.\n\nSunquest Mitogen\n\nNo\n\nUnited States\n\nDemonstration videos\n\nMitogen is an integration of UNIConnect and GeneInsight products.\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.[23]\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\nDemonstration 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 \"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_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:15.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","13e646a1466068f9c15573c3a34ab4fd_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Resources_for_selecting_and_implementing_informatics_solutions_LIMS_vendors rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_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 Food Safety and Quality\/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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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 the food and beverage industry, see the <a href=\"https:\/\/www.limswiki.org\/index.php\/Category:Food_and_beverage_LIMS\" title=\"Category:Food and beverage LIMS\" class=\"wiki-link\" data-key=\"c1a32479e81674963794aec0be3d4090\">listing of food and beverage LIMS vendors<\/a>.\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\" 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\/Benchling,_Inc.\" title=\"Benchling, Inc.\" class=\"wiki-link\" data-key=\"67634090ee7d17da2ed0d3748a65379d\">Benchling, Inc.<\/a>\n<\/td>\n<td>Benchling Notebook\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Benchling,_Inc.#Pricing\" title=\"Benchling, Inc.\" class=\"wiki-link\" data-key=\"2221138a875ba7c231772538e0366e45\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Benchling,_Inc.#Demonstration_videos_and_other_media\" title=\"Benchling, Inc.\" class=\"wiki-link\" data-key=\"1ed073efb7914309b944fc59b08e7473\">demonstration videos<\/a>\n<\/td>\n<td>All but Enterprise pricing made public.\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>\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 and 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\/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, Azenta Lifecycle<br \/>Management Platform\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>WinPath Enterprise\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\/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\/Common_Cents_Systems,_Inc.\" title=\"Common Cents Systems, Inc.\" class=\"wiki-link\" data-key=\"6a1feb534350b460ef3eaa83ab477633\">Common Cents Systems, Inc.<\/a>\n<\/td>\n<td>ApolloLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Formerly marketed Cirrus and M\/LAB as preceding products\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_7-0\" class=\"reference\"><a href=\"#cite_note-DassAcqFinal-7\">[7]<\/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_8-0\" class=\"reference\"><a href=\"#cite_note-ToetTelekom19-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FinalistAcq_9-0\" class=\"reference\"><a href=\"#cite_note-FinalistAcq-9\">[9]<\/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#Pricing\" title=\"Fink & Partner GmbH\" class=\"wiki-link\" data-key=\"89f632ae74caec443ec4270992ab8436\">Pricing<\/a> and <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_10-0\" class=\"reference\"><a href=\"#cite_note-CaliberFA-10\">[10]<\/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\/HORIZON_Lab_Systems,_LLC\" title=\"HORIZON Lab Systems, LLC\" class=\"wiki-link\" data-key=\"b31b48db809e8608b5de7f64da02b6f0\">HORIZON Lab Systems, LLC<\/a>\n<\/td>\n<td>HORIZON LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/HORIZON_Lab_Systems,_LLC#Pricing\" title=\"HORIZON Lab Systems, LLC\" class=\"wiki-link\" data-key=\"289a7136da2a4544e195a0c07dfcad48\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/HORIZON_Lab_Systems,_LLC#Demonstration_videos_and_other_media\" title=\"HORIZON Lab Systems, LLC\" class=\"wiki-link\" data-key=\"859bce39a2e3e440b6431926b4c2d386\">demonstration videos<\/a>\n<\/td>\n<td>Formerly ChemWare, Inc.\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_11-0\" class=\"reference\"><a href=\"#cite_note-MWDasQM19-11\">[11]<\/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>\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_12-0\" class=\"reference\"><a href=\"#cite_note-PCSArch-12\">[12]<\/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>\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_13-0\" class=\"reference\"><a href=\"#cite_note-IntegrisRenaming17-13\">[13]<\/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_14-0\" class=\"reference\"><a href=\"#cite_note-NobileRiverside21-14\">[14]<\/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\/Junction_Concepts,_Inc.\" title=\"Junction Concepts, Inc.\" class=\"wiki-link\" data-key=\"db728c00d9a437cf664e26d88af95fc4\">Junction Concepts, 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>\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> and <a href=\"https:\/\/www.limswiki.org\/index.php\/JusticeTrax,_Inc.#Demonstration_videos_and_other_media\" title=\"JusticeTrax, Inc.\" class=\"wiki-link\" data-key=\"eb2e3c3e3c37057acaeca2174fe71fc3\">Demonstration videos<\/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.#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, CannaQA, webLIMS\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_15-0\" class=\"reference\"><a href=\"#cite_note-LWPressAcq-15\">[15]<\/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>Lab-i, CLab-i\n<\/td>\n<td>No\n<\/td>\n<td>South Africa\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\/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, 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>United States\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-16\" class=\"reference\"><a href=\"#cite_note-16\">[16]<\/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> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Progeny_Genetics,_LLC#Demonstration_videos_and_other_media\" title=\"Progeny Genetics, LLC\" class=\"wiki-link\" data-key=\"cc5ff43b353b346399c8379dbb0efc9b\">demonstration videos<\/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\/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_17-0\" class=\"reference\"><a href=\"#cite_note-CylexRhapsody-17\">[17]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-OHRSoftwaresysteme_18-0\" class=\"reference\"><a href=\"#cite_note-OHRSoftwaresysteme-18\">[18]<\/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-19\" class=\"reference\"><a href=\"#cite_note-19\">[19]<\/a><\/sup> C5 LIMS was renamed to<br \/>\"LABVANTAGE Medical Suite\" in December 2012.<sup id=\"rdp-ebb-cite_ref-20\" class=\"reference\"><a href=\"#cite_note-20\">[20]<\/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_21-0\" class=\"reference\"><a href=\"#cite_note-OSArch1-21\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SPArch1_22-0\" class=\"reference\"><a href=\"#cite_note-SPArch1-22\">[22]<\/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\/Sunquest_Information_Systems,_Inc.\" title=\"Sunquest Information Systems, Inc.\" class=\"wiki-link\" data-key=\"f4a9158f6e03a611d3ceec4b5ff31702\">Sunquest Information Systems, Inc.<\/a>\n<\/td>\n<td>Sunquest Mitogen\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Sunquest_Information_Systems,_Inc.#Demonstration_videos_and_other_media\" title=\"Sunquest Information Systems, Inc.\" class=\"wiki-link\" data-key=\"30d3f7e8e300186a19c7ebdc1cc191dd\">Demonstration videos<\/a>\n<\/td>\n<td>Mitogen is an integration of <a href=\"https:\/\/www.limswiki.org\/index.php\/UNIConnect_LC\" title=\"UNIConnect LC\" class=\"wiki-link\" data-key=\"a7193eda538dc078bcd6121051c78727\">UNIConnect<\/a> and GeneInsight products.\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_23-0\" class=\"reference\"><a href=\"#cite_note-NG8PDF-23\">[23]<\/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#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_Food_Safety_and_Quality\/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>. Agilent Technologies, Inc. 1 August 2016<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.agilent.com\/about\/newsroom\/presrel\/2016\/01aug-gp16015.html\" target=\"_blank\">http:\/\/www.agilent.com\/about\/newsroom\/presrel\/2016\/01aug-gp16015.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 20 April 2017<\/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=Agilent+Technologies+Completes+Asset+Acquisition+of+iLab+Solutions%2C+a+Leader+in+Cloud-Based+Laboratory+Management+Software&rft.atitle=&rft.date=1+August+2016&rft.pub=Agilent+Technologies%2C+Inc&rft_id=http%3A%2F%2Fwww.agilent.com%2Fabout%2Fnewsroom%2Fpresrel%2F2016%2F01aug-gp16015.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BarraudUSGroup18-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BarraudUSGroup18_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Barraud, E. (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\">. Retrieved 15 May 2018<\/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=US+group+Agilent+enters+EPFL+Innovation+Park+by+acquiring+Genohm&rft.atitle=EPFL+News&rft.aulast=Barraud%2C+E.&rft.au=Barraud%2C+E.&rft.date=2+May+2018&rft.pub=%C3%89cole+polytechnique+f%C3%A9d%C3%A9rale+de+Lausanne&rft_id=https%3A%2F%2Factu.epfl.ch%2Fnews%2Fus-group-agilent-enters-epfl-innovation-park-by-ac%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KCGenohm18-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KCGenohm18_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.kellerhals-carrard.ch\/fr\/genohm-sa-closes-its-sale-to-agilent-technologies-ltd-_content---1--8--460.html\" target=\"_blank\">\"Genohm SA closes its sale to Agilent Technologies Ltd\"<\/a>. Kellerhals Carrard. 14 May 2018<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.kellerhals-carrard.ch\/fr\/genohm-sa-closes-its-sale-to-agilent-technologies-ltd-_content---1--8--460.html\" target=\"_blank\">https:\/\/www.kellerhals-carrard.ch\/fr\/genohm-sa-closes-its-sale-to-agilent-technologies-ltd-_content---1--8--460.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 15 May 2018<\/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=Genohm+SA+closes+its+sale+to+Agilent+Technologies+Ltd&rft.atitle=&rft.date=14+May+2018&rft.pub=Kellerhals+Carrard&rft_id=https%3A%2F%2Fwww.kellerhals-carrard.ch%2Ffr%2Fgenohm-sa-closes-its-sale-to-agilent-technologies-ltd-_content---1--8--460.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AutoZum-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AutoZum_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.americanlaboratory.com\/Specialty\/Forensics\/617-News\/37427-Autoscribe-launches-US-operation\/\" target=\"_blank\">\"Autoscribe launches US operation\"<\/a>. <i>American Laboratory<\/i>. CompareNetworks, Inc. 20 March 2012<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.americanlaboratory.com\/Specialty\/Forensics\/617-News\/37427-Autoscribe-launches-US-operation\/\" target=\"_blank\">http:\/\/www.americanlaboratory.com\/Specialty\/Forensics\/617-News\/37427-Autoscribe-launches-US-operation\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 19 January 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=Autoscribe+launches+US+operation&rft.atitle=American+Laboratory&rft.date=20+March+2012&rft.pub=CompareNetworks%2C+Inc&rft_id=http%3A%2F%2Fwww.americanlaboratory.com%2FSpecialty%2FForensics%2F617-News%2F37427-Autoscribe-launches-US-operation%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PRNBentley19-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PRNBentley19_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Bentley Systems, Inc (13 May 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.prnewswire.com\/news-releases\/bentley-systems-announces-the-acquisition-of-keynetix-provider-of-geotechnical-data-management-cloud-services-300848796.html\" target=\"_blank\">\"Bentley Systems Announces the Acquisition of Keynetix, Provider of Geotechnical Data Management Cloud Services\"<\/a>. <i>PR Newswire<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.prnewswire.com\/news-releases\/bentley-systems-announces-the-acquisition-of-keynetix-provider-of-geotechnical-data-management-cloud-services-300848796.html\" target=\"_blank\">https:\/\/www.prnewswire.com\/news-releases\/bentley-systems-announces-the-acquisition-of-keynetix-provider-of-geotechnical-data-management-cloud-services-300848796.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 25 October 2020<\/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=Bentley+Systems+Announces+the+Acquisition+of+Keynetix%2C+Provider+of+Geotechnical+Data+Management+Cloud+Services&rft.atitle=PR+Newswire&rft.aulast=Bentley+Systems%2C+Inc&rft.au=Bentley+Systems%2C+Inc&rft.date=13+May+2019&rft_id=https%3A%2F%2Fwww.prnewswire.com%2Fnews-releases%2Fbentley-systems-announces-the-acquisition-of-keynetix-provider-of-geotechnical-data-management-cloud-services-300848796.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DassAcqFinal-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DassAcqFinal_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.3ds.com\/press-releases\/single\/dassault-systemes-successfully-completes-acquisition-of-accelrys\/\" target=\"_blank\">\"Dassault Syst\u00e8mes Successfully Completes Acquisition of Accelrys\"<\/a>. 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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_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><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 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_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-20\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-20\">\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_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-OSArch1-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-OSArch1_21-0\">\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_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SPArch1-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SPArch1_22-0\">\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_Food_Safety_and_Quality\/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-23\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NG8PDF_23-0\">\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_Food_Safety_and_Quality\/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: 20230110191555\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.239 seconds\nReal time usage: 0.248 seconds\nPreprocessor visited node count: 15212\/1000000\nPost\u2010expand include size: 198670\/2097152 bytes\nTemplate argument size: 45507\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 35955\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 147.097 1 -total\n 90.55% 133.194 1 Template:Reflist\n 79.98% 117.653 23 Template:Cite_web\n 75.22% 110.648 23 Template:Citation\/core\n 14.65% 21.546 15 Template:Date\n 9.41% 13.835 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\n 8.11% 11.926 1 Template:All_active_LIMS_vendors\n 5.05% 7.427 36 Template:Citation\/make_link\n 1.15% 1.690 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13934-0!canonical and timestamp 20230110191555 and revision id 50885. 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_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/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>","13e646a1466068f9c15573c3a34ab4fd_images":[],"13e646a1466068f9c15573c3a34ab4fd_timestamp":1673378971,"3e174e8473680146231974161b92fbba_type":"article","3e174e8473680146231974161b92fbba_title":"3.4 How a user requirements specification fits into the entire process (LIMSpec)","3e174e8473680146231974161b92fbba_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)","3e174e8473680146231974161b92fbba_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Choosing laboratory informatics software for your food and beverage 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 food and beverage 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 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 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 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 25 September 2019. https:\/\/web.archive.org\/web\/20190925003040\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/ . 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: 3. Choosing laboratory informatics software for your food and beverage lab\nTitle: LIMS Selection Guide for Food Safety and Quality\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:15.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","3e174e8473680146231974161b92fbba_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab_How_a_user_requirements_specification_fits_into_the_entire_process_LIMSpec rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Choosing_laboratory_informatics_software_for_your_food_and_beverage_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 Food Safety and Quality\/Choosing laboratory informatics software for your food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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 food and beverage 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 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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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 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=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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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 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=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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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 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+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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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 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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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 07 December 2022<\/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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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\">. 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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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-BurrissSoftware07-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BurrissSoftware07_9-0\">\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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Resources for selecting and implementing informatics solutions\/LIMS vendors\" class=\"wiki-link\" data-key=\"13e646a1466068f9c15573c3a34ab4fd\">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 food and beverage lab\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for Food Safety and Quality<\/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>: January 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230110191638\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.079 seconds\nReal time usage: 0.084 seconds\nPreprocessor visited node count: 6294\/1000000\nPost\u2010expand include size: 52068\/2097152 bytes\nTemplate argument size: 17709\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 15910\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 76.524 1 -total\n 91.84% 70.283 1 Template:Reflist\n 69.72% 53.349 9 Template:Citation\/core\n 58.75% 44.960 7 Template:Cite_web\n 21.47% 16.433 2 Template:Cite_journal\n 11.34% 8.674 6 Template:Date\n 8.06% 6.167 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\n 6.96% 5.329 1 Template:Citation\/identifier\n 4.74% 3.628 14 Template:Citation\/make_link\n 2.00% 1.534 2 Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13933-0!canonical and timestamp 20230110191638 and revision id 50884. 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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/How_a_user_requirements_specification_fits_into_the_entire_process_(LIMSpec)\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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>","3e174e8473680146231974161b92fbba_images":[],"3e174e8473680146231974161b92fbba_timestamp":1673378971,"ccc5e25aa4604bc93620e0c530d9cb6a_type":"article","ccc5e25aa4604bc93620e0c530d9cb6a_title":"3.3 MSW, updates, and other contracted services","ccc5e25aa4604bc93620e0c530d9cb6a_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/MSW,_updates,_and_other_contracted_services","ccc5e25aa4604bc93620e0c530d9cb6a_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Choosing laboratory informatics software for your food and beverage 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. https:\/\/www.computereconomics.com\/article.cfm?id=1033 . Retrieved 07 December 2022 .   \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 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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/MSW,_updates,_and_other_contracted_services\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/MSW,_updates,_and_other_contracted_services<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:13.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","ccc5e25aa4604bc93620e0c530d9cb6a_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab_MSW_updates_and_other_contracted_services rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Choosing_laboratory_informatics_software_for_your_food_and_beverage_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 Food Safety and Quality\/Choosing laboratory informatics software for your food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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:\/\/www.computereconomics.com\/article.cfm?id=1033\" target=\"_blank\">\"High Software Maintenance Fees and What to Do About Them\"<\/a>. <i>Computer Economics<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.computereconomics.com\/article.cfm?id=1033\" target=\"_blank\">https:\/\/www.computereconomics.com\/article.cfm?id=1033<\/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=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%2Fwww.computereconomics.com%2Farticle.cfm%3Fid%3D1033&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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 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=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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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: 20230110191319\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.042 seconds\nReal time usage: 0.049 seconds\nPreprocessor visited node count: 1539\/1000000\nPost\u2010expand include size: 15737\/2097152 bytes\nTemplate argument size: 5506\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 3847\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 38.593 1 -total\n 79.74% 30.774 1 Template:Reflist\n 60.13% 23.207 2 Template:Cite_web\n 51.62% 19.920 2 Template:Citation\/core\n 20.00% 7.717 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/MSW,_updates,_and_other_contracted_services\n 12.21% 4.713 2 Template:Date\n 6.29% 2.426 5 Template:Citation\/make_link\n 4.70% 1.812 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13932-0!canonical and timestamp 20230110191320 and revision id 50883. 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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/MSW,_updates,_and_other_contracted_services\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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>","ccc5e25aa4604bc93620e0c530d9cb6a_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"],"ccc5e25aa4604bc93620e0c530d9cb6a_timestamp":1673378971,"f040e0fcf8fe01d87aefc3592c454852_type":"article","f040e0fcf8fe01d87aefc3592c454852_title":"3.2 Implementation","f040e0fcf8fe01d87aefc3592c454852_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Implementation","f040e0fcf8fe01d87aefc3592c454852_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Choosing laboratory informatics software for your food and beverage 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 \nLaboratories 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 your 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. 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.[3] The LIMS that can support such instrument integrations is increasingly vital to the food and beverage laboratory. Food and beverage 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.[4][5][6] 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.[5]\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 07 December 2022 .   \n \n\n\u2191 Mura, A. (12 July 2018). \"Bullet-Proof Software Implementation Plan: Challenges and Tactics\". Userlane Digital Adoption Blog. Userlane GmbH. https:\/\/www.userlane.com\/software-implementation-plan\/ . Retrieved 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 5.0 5.1 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 07 December 2022 .   \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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Implementation\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Implementation<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:12.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","f040e0fcf8fe01d87aefc3592c454852_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab_Implementation rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Choosing_laboratory_informatics_software_for_your_food_and_beverage_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 Food Safety and Quality\/Choosing laboratory informatics software for your food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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>Laboratories 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 your 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. 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_3-0\" class=\"reference\"><a href=\"#cite_note-WilliamsComp-3\">[3]<\/a><\/sup> The LIMS that can support such instrument integrations is increasingly vital to the food and beverage laboratory. Food and beverage 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_4-0\" class=\"reference\"><a href=\"#cite_note-MonusSOAP19-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LVAQuick18_5-0\" class=\"reference\"><a href=\"#cite_note-LVAQuick18-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GrandOneTool19_6-0\" class=\"reference\"><a href=\"#cite_note-GrandOneTool19-6\">[6]<\/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_5-1\" class=\"reference\"><a href=\"#cite_note-LVAQuick18-5\">[5]<\/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 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=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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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:\/\/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<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.userlane.com\/software-implementation-plan\/\" target=\"_blank\">https:\/\/www.userlane.com\/software-implementation-plan\/<\/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=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%2Fwww.userlane.com%2Fsoftware-implementation-plan%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WilliamsComp-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WilliamsComp_3-0\">\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 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=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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MonusSOAP19-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MonusSOAP19_4-0\">\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 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=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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LVAQuick18-5\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-LVAQuick18_5-0\">5.0<\/a><\/sup> <sup><a href=\"#cite_ref-LVAQuick18_5-1\">5.1<\/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 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=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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GrandOneTool19-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GrandOneTool19_6-0\">\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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230110191247\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.067 seconds\nReal time usage: 0.079 seconds\nPreprocessor visited node count: 4245\/1000000\nPost\u2010expand include size: 31852\/2097152 bytes\nTemplate argument size: 9238\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 9261\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 73.259 1 -total\n 84.81% 62.133 1 Template:Reflist\n 59.98% 43.937 6 Template:Citation\/core\n 51.19% 37.503 5 Template:Cite_web\n 20.95% 15.350 1 Template:Cite_journal\n 15.07% 11.041 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Implementation\n 10.40% 7.620 4 Template:Date\n 8.60% 6.302 1 Template:Citation\/identifier\n 4.38% 3.207 9 Template:Citation\/make_link\n 2.53% 1.852 2 Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13931-0!canonical and timestamp 20230110191250 and revision id 50882. 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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Implementation\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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>","f040e0fcf8fe01d87aefc3592c454852_images":[],"f040e0fcf8fe01d87aefc3592c454852_timestamp":1673378970,"85c23189f7dd8f52181f96a16f048ed1_type":"article","85c23189f7dd8f52181f96a16f048ed1_title":"3.1 Evaluation and selection","85c23189f7dd8f52181f96a16f048ed1_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection","85c23189f7dd8f52181f96a16f048ed1_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Choosing laboratory informatics software for your food and beverage 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 food and beverage 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 food and beverage 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 food and beverage lab?\" but rather \"how do I choose and implement an informatics system to help my food and beverage 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 allergen, calorie, and nutrition 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 formulation requests, or do they envision expansive growth, expanding into multiple food and beverage 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 Laboratory Accreditation for Analyses of Foods (LAAF)-accredited testing 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 a food and beverage 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. \nThe use of LIMS in food production facilities and labs is not a new concept.[12] However, little information can be found as to the percentage of today's food and beverage laboratories using a LIMS in their workflow. Several surveys from 2020, however, hint that LIMS are important to these types of labs. A survey of 135 professionals\u2014nine percent of them from the food and beverage industry\u2014from laboratory consultancy Astrix Technology found that more than 77 percent of respondents had at least one LIMS implemented in their organization.[13] A separate survey from Lab Manager about analytical instrument use among readers found that more than 16 percent of them were using instruments for food and beverage analysis.[14] Given the importance of integrating instrumentation and produced data in a food and beverage production and testing environment[15][16][17], a LIMS or other informatics solution appears to be increasingly critical to eliminating manual processes, improving sample management, increasing productivity, and improving regulatory conformance.[13] This, of course, lends to the food and beverage 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 ingredients, additives, quality control samples, standard operating procedures (SOPs), environmental monitoring data, chain of custody data, and other vital aspects of food and beverage production. 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. Given the regulatory demands for providing rapid proof of traceable product movement and relevant quality control data, the LIMS acts as the central integrator and audit trail for that information.[15][18][19] 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, food and beverage producers can more rapidly act on insights gained from those real-time dashboards.[15] This is also means that the food and beverage testing lab can react more rapidly to issues that compromise compliance with certification to the ISO 17025 standard or the FDA's Food Safety Modernization Act (FSMA) requirements.[16][20][21][22] Finally, many modern LIMS tailored to the food and beverage 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.[23]\nHowever, the LIMS is not the sole information management solution for food and beverage producers and laboratories. Software-based information management solutions are being marketed to food and beverage labs in other ways. 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).[24][25] Other vendors have moved away from the \"LIMS\" and \"LES\" moniker completely, referring to their software as simply \"food safety software.\" These offerings appear to focus on helping a producer do more than manage laboratory testing output by addressing other organizational needs such as developing regulatory-driven safety plans, generating schedules for environmental testing, improving communication and compliance, improving reaction time to non-conformances, improving audit readiness and reporting, ensuring greater compliance, and identifying trends across the entire enterprise.[26][27][28][29][30] In comparison, some LIMS may or may not address these issues; 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 food and beverage 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 food and beverage laboratory. The following examines both the base features and specialty requirements of a food and beverage LIMS.\n3.1.2.1 Base features\nWhat follows is a list of system functionality important to most any food and beverage laboratory, with a majority of that functionality found in many vendor software solutions.[15][16][18][19][23][24][31]\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\nQuality, security, and compliance\n\nQuality assurance \/ quality control mechanisms\nMechanisms for compliance with ISO 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 food and beverage processor needs beyond the basic laboratory through their food safety software. A standard LIMS tailored for the food and beverage industry 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 food and beverage LIMS vendor may also include specialized functionality that helps the food and beverage producer and its laboratory[24][26][27][28][30][31][32][33][34][35][36][37]:\n\nManage stability studies: Just as with the pharmaceutical industry, stability studies play an important role in food and beverage safety. These studies require careful statistical analysis, predictive modelling, 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, 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 that the HACCP rules, in particular, mandate the creation and management of batch production and in-process manufacturing material records, some food and beverage facilities testing batches and manufacturing materials may appreciate support in this regard.\nSupport molecular biology workflows: Molecular biology is an important tool in the research of improving foods, beverages, and their ingredients. 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 food and beverage LIMS that also supports these workflow tasks.\nTake advantage of ELN functionality: Given the level of R&D to be found in a food and beverage facility, 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 Hazard Analysis and Critical Control Points (HACCP) quality control method is recommended or required for food and testing labs (and is an influence on ISO 17025). 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 testing: 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 food and beverage facility, and not all food and beverage LIMS can provide.\n3.1.3 Cybersecurity considerations \nFrom law firms[38] to automotive manufacturers[39], 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[40], 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[41] In the end, businesses of all sizes average about $200,000 in losses due to a cybersecurity incident[42], and nearly 60 percent of small and midsize businesses go bankrupt within six months because of it.[43]\nFood and beverage 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.[44][45][46] Even more importantly are those labs performing digital data management tasks that handle sensitive proprietary manufacturer data, requiring additional cybersecurity considerations.\nA food and beverage 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.\"[47] 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 food and beverage 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 test results, the safety of end users, and the promise of maintaining traceability across the utilized food 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 Codex Alimentarius CXS 234-1999 Recommended Methods of Analysis and Sampling to 21 CFR Part 120 (concerning hazard analysis and critical control point [HACCP] systems) and Safe Food for Canadians Regulations SOR\/2018-108, 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[48][49], 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\"[49] 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.[48] 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 food and beverage 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 food authenticity and adulteration testing, does your existing laboratory informatics system\u2014or the ones you may be considering\u2014have the flexibility to add other types of food and beverage 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 food 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' costings. 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 the 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). 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Food Safety Tech. https:\/\/foodsafetytech.com\/feature_article\/the-digital-transformation-of-global-food-security\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 Paszko, C. (19 August 2015). \"Traceability: Leveraging Automation to Satisfy FSMA Requirements\". Food Safety Tech. https:\/\/foodsafetytech.com\/feature_article\/traceability-leveraging-automation-to-satisfy-fsma-requirements\/ . Retrieved 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 Daniels, T. (22 March 2017). \"Using LIMS to Get In Shape for FDA\u2019s Visit\". Food Safety Tech. https:\/\/foodsafetytech.com\/column\/using-lims-get-shape-fdas-visit\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 23.0 23.1 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 07 December 2022 .   \n \n\n\u2191 24.0 24.1 24.2 \"iLES Food & Beverages Lab Execution\". iVention BV. https:\/\/hs.iles.cloud\/en\/food-and-beverages-lab-execution . Retrieved 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 26.0 26.1 \"What Is a Food Intelligence Platform? LIMS vs. Food Safety Software\". 9 May 2019. https:\/\/corvium.com\/what-is-a-food-intelligence-platform-lims-vs-food-safety-software\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 27.0 27.1 \"Safety & Quality Management\". FoodLogiQ. https:\/\/www.foodlogiq.com\/solutions\/safety-and-quality\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 28.0 28.1 \"Food Safety Software\". SafetyChain Software, Inc. https:\/\/safetychain.com\/food-safety-software\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 \"Best Food Safety Software For Quality Management Of Food\". Folio3 Software, Inc. https:\/\/agtech.folio3.com\/food-safety-software\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 30.0 30.1 \"FoodDocs: AI-Powered Food Safety System with a HACCP builder\". FoodDocs. https:\/\/www.fooddocs.com\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 31.0 31.1 \"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 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 Chen, Xinyu; Voigt, Tobias (1 August 2020). \"Implementation of the Manufacturing Execution System in the food and beverage industry\" (in en). Journal of Food Engineering 278: 109932. doi:10.1016\/j.jfoodeng.2020.109932.   \n \n\n\u2191 Kilcast, David; Subramaniam, Persis, eds. (2011). Food and beverage stability and shelf life. Woodhead Publishing series in food science, technology and nutrition. Oxford: WP, Woodhead Publ. ISBN 978-0-85709-254-0. OCLC 838321011. https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/838321011 .   \n \n\n\u2191 Wolinsky, Howard; Husted, Kristofor (1 March 2015). \"Science for food: Molecular biology contributes to the production and preparation of food\" (in en). EMBO reports 16 (3): 272\u2013275. doi:10.15252\/embr.201540128. ISSN 1469-221X. PMC PMC4364866. PMID 25691389. https:\/\/onlinelibrary.wiley.com\/doi\/10.15252\/embr.201540128 .   \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 \"Nucleic Acid Extraction For Food And Beverage Testing\". Thermo Fisher Scientific. https:\/\/www.thermofisher.com\/us\/en\/home\/industrial\/food-beverage\/food-analytical-testing\/sample-prep-nucleic-acid-protein-isolation.html . Retrieved 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 48.0 48.1 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 49.0 49.1 \"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 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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:12.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","85c23189f7dd8f52181f96a16f048ed1_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab_Evaluation_and_selection rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Choosing_laboratory_informatics_software_for_your_food_and_beverage_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 Food Safety and Quality\/Choosing laboratory informatics software for your food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h2><span class=\"mw-headline\" id=\"3._Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\">3. Choosing laboratory informatics software for your food and beverage lab<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:FDA_Center_for_Food_Safety_%26_Applied_Nutrition_(CFSAN)_6536.jpg\" class=\"image wiki-link\" data-key=\"9bc850c3dce5a223ded9194b7f00da66\"><img alt=\"FDA Center for Food Safety & Applied Nutrition (CFSAN) 6536.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/6\/6b\/FDA_Center_for_Food_Safety_%26_Applied_Nutrition_%28CFSAN%29_6536.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/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 food and beverage lab?\" but rather \"how do I choose and implement an informatics system to help my food and beverage 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<div class=\"floatleft\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:FDA_Center_for_Food_Safety_%26_Applied_Nutrition_(CFSAN)_6496_(8756119526).jpg\" class=\"image wiki-link\" data-key=\"518ebbc440c86646907516c121597560\"><img alt=\"FDA Center for Food Safety & Applied Nutrition (CFSAN) 6496 (8756119526).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/8\/88\/FDA_Center_for_Food_Safety_%26_Applied_Nutrition_%28CFSAN%29_6496_%288756119526%29.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><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 allergen, calorie, and nutrition 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 formulation requests, or do they envision expansive growth, expanding into multiple food and beverage 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 Laboratory Accreditation for Analyses of Foods (LAAF)-accredited testing 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 a food and beverage 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. \n<\/p><p>The use of LIMS in food production facilities and labs is not a new concept.<sup id=\"rdp-ebb-cite_ref-12\" class=\"reference\"><a href=\"#cite_note-12\">[12]<\/a><\/sup> However, little information can be found as to the percentage of today's food and beverage laboratories using a LIMS in their workflow. Several surveys from 2020, however, hint that LIMS are important to these types of labs. A survey of 135 professionals\u2014nine percent of them from the food and beverage industry\u2014from laboratory consultancy Astrix Technology found that more than 77 percent of respondents had at least one LIMS implemented in their organization.<sup id=\"rdp-ebb-cite_ref-Astrix2020LIMS_13-0\" class=\"reference\"><a href=\"#cite_note-Astrix2020LIMS-13\">[13]<\/a><\/sup> A separate survey from <i>Lab Manager<\/i> about analytical instrument use among readers found that more than 16 percent of them were using instruments for food and beverage analysis.<sup id=\"rdp-ebb-cite_ref-Crawford-BrownResults20_14-0\" class=\"reference\"><a href=\"#cite_note-Crawford-BrownResults20-14\">[14]<\/a><\/sup> Given the importance of integrating instrumentation and produced data in a food and beverage production and testing environment<sup id=\"rdp-ebb-cite_ref-SmithInteg19_15-0\" class=\"reference\"><a href=\"#cite_note-SmithInteg19-15\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ApteIsYour20_16-0\" class=\"reference\"><a href=\"#cite_note-ApteIsYour20-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SiemensProcess22_17-0\" class=\"reference\"><a href=\"#cite_note-SiemensProcess22-17\">[17]<\/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_13-1\" class=\"reference\"><a href=\"#cite_note-Astrix2020LIMS-13\">[13]<\/a><\/sup> This, of course, lends to the food and beverage 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 ingredients, additives, quality control samples, standard operating procedures (SOPs), environmental monitoring data, chain of custody data, and other vital aspects of food and beverage production. 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. Given the regulatory demands for providing rapid proof of traceable product movement and relevant quality control data, the LIMS acts as the central integrator and audit trail for that information.<sup id=\"rdp-ebb-cite_ref-SmithInteg19_15-1\" class=\"reference\"><a href=\"#cite_note-SmithInteg19-15\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-McDermottHowDig18_18-0\" class=\"reference\"><a href=\"#cite_note-McDermottHowDig18-18\">[18]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EvansTheDig19_19-0\" class=\"reference\"><a href=\"#cite_note-EvansTheDig19-19\">[19]<\/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, food and beverage producers can more rapidly act on insights gained from those real-time dashboards.<sup id=\"rdp-ebb-cite_ref-SmithInteg19_15-2\" class=\"reference\"><a href=\"#cite_note-SmithInteg19-15\">[15]<\/a><\/sup> This is also means that the food and beverage testing lab can react more rapidly to issues that compromise compliance with certification to the <a href=\"https:\/\/www.limswiki.org\/index.php\/ISO_17025\" class=\"mw-redirect wiki-link\" title=\"ISO 17025\" data-key=\"e8525a8d5d35bc9c3c1015749eb8de05\">ISO 17025<\/a> standard or the FDA's <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\">Food Safety Modernization Act<\/a> (FSMA) requirements.<sup id=\"rdp-ebb-cite_ref-ApteIsYour20_16-1\" class=\"reference\"><a href=\"#cite_note-ApteIsYour20-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PaszkoTrace15_20-0\" class=\"reference\"><a href=\"#cite_note-PaszkoTrace15-20\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PaszkoHow15_21-0\" class=\"reference\"><a href=\"#cite_note-PaszkoHow15-21\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DanielsUsing17_22-0\" class=\"reference\"><a href=\"#cite_note-DanielsUsing17-22\">[22]<\/a><\/sup> Finally, many modern LIMS tailored to the food and beverage 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_23-0\" class=\"reference\"><a href=\"#cite_note-IngallsHowAdv20-23\">[23]<\/a><\/sup>\n<\/p><p>However, the LIMS is not the sole information management solution for food and beverage producers and laboratories. Software-based information management solutions are being marketed to food and beverage labs in other ways. 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_24-0\" class=\"reference\"><a href=\"#cite_note-iVentionLES-24\">[24]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LVSHowLIMS20_25-0\" class=\"reference\"><a href=\"#cite_note-LVSHowLIMS20-25\">[25]<\/a><\/sup> Other vendors have moved away from the \"LIMS\" and \"LES\" moniker completely, referring to their software as simply \"food safety software.\" These offerings appear to focus on helping a producer do more than manage laboratory testing output by addressing other organizational needs such as developing regulatory-driven safety plans, generating schedules for environmental testing, improving communication and compliance, improving reaction time to non-conformances, improving audit readiness and reporting, ensuring greater compliance, and identifying trends across the entire enterprise.<sup id=\"rdp-ebb-cite_ref-CorviumWhatIs19_26-0\" class=\"reference\"><a href=\"#cite_note-CorviumWhatIs19-26\">[26]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FLQSafety_27-0\" class=\"reference\"><a href=\"#cite_note-FLQSafety-27\">[27]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SCFoodSafety_28-0\" class=\"reference\"><a href=\"#cite_note-SCFoodSafety-28\">[28]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-F3AgTechBest_29-0\" class=\"reference\"><a href=\"#cite_note-F3AgTechBest-29\">[29]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FDAIPower_30-0\" class=\"reference\"><a href=\"#cite_note-FDAIPower-30\">[30]<\/a><\/sup> In comparison, some LIMS may or may not address these issues; 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 food and beverage 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 food and beverage laboratory. The following examines both the base features and specialty requirements of a food and beverage 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 food and beverage laboratory, with a majority of that functionality found in many vendor software solutions.<sup id=\"rdp-ebb-cite_ref-SmithInteg19_15-3\" class=\"reference\"><a href=\"#cite_note-SmithInteg19-15\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ApteIsYour20_16-2\" class=\"reference\"><a href=\"#cite_note-ApteIsYour20-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-McDermottHowDig18_18-1\" class=\"reference\"><a href=\"#cite_note-McDermottHowDig18-18\">[18]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EvansTheDig19_19-1\" class=\"reference\"><a href=\"#cite_note-EvansTheDig19-19\">[19]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-IngallsHowAdv20_23-1\" class=\"reference\"><a href=\"#cite_note-IngallsHowAdv20-23\">[23]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-iVentionLES_24-1\" class=\"reference\"><a href=\"#cite_note-iVentionLES-24\">[24]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-StarlimsFood22_31-0\" class=\"reference\"><a href=\"#cite_note-StarlimsFood22-31\">[31]<\/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><\/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 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>\n<\/p><p>As noted previously, some software vendors are addressing food and beverage processor needs beyond the basic laboratory through their food safety software. A standard LIMS tailored for the food and beverage industry 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 food and beverage LIMS vendor may also include specialized functionality that helps the food and beverage producer and its laboratory<sup id=\"rdp-ebb-cite_ref-iVentionLES_24-2\" class=\"reference\"><a href=\"#cite_note-iVentionLES-24\">[24]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CorviumWhatIs19_26-1\" class=\"reference\"><a href=\"#cite_note-CorviumWhatIs19-26\">[26]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FLQSafety_27-1\" class=\"reference\"><a href=\"#cite_note-FLQSafety-27\">[27]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SCFoodSafety_28-1\" class=\"reference\"><a href=\"#cite_note-SCFoodSafety-28\">[28]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FDAIPower_30-1\" class=\"reference\"><a href=\"#cite_note-FDAIPower-30\">[30]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-StarlimsFood22_31-1\" class=\"reference\"><a href=\"#cite_note-StarlimsFood22-31\">[31]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Douglas_32-0\" class=\"reference\"><a href=\"#cite_note-Douglas-32\">[32]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-33\" class=\"reference\"><a href=\"#cite_note-33\">[33]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-34\" class=\"reference\"><a href=\"#cite_note-34\">[34]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-35\" class=\"reference\"><a href=\"#cite_note-35\">[35]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-36\" class=\"reference\"><a href=\"#cite_note-36\">[36]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ThermoNucleicAcid_37-0\" class=\"reference\"><a href=\"#cite_note-ThermoNucleicAcid-37\">[37]<\/a><\/sup>:\n<\/p>\n<ul><li><b>Manage stability studies<\/b>: Just as with the pharmaceutical industry, stability studies play an important role in food and beverage safety. These studies require careful statistical analysis, predictive modelling, 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, 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 that the HACCP rules, in particular, mandate the creation and management of batch production and in-process manufacturing material records, some food and beverage facilities 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 the research of improving foods, beverages, and their ingredients. 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 food and beverage 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 a food and beverage facility, 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 Hazard Analysis and Critical Control Points (HACCP) quality control method is recommended or required for food and testing labs (and is an influence on ISO 17025). 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 testing<\/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 food and beverage facility, and not all food and beverage LIMS can provide.<\/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_38-0\" class=\"reference\"><a href=\"#cite_note-SobowaleLaw17-38\">[38]<\/a><\/sup> to automotive manufacturers<sup id=\"rdp-ebb-cite_ref-WatneyAddress17_39-0\" class=\"reference\"><a href=\"#cite_note-WatneyAddress17-39\">[39]<\/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_40-0\" class=\"reference\"><a href=\"#cite_note-LewisEcon18-40\">[40]<\/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_41-0\" class=\"reference\"><a href=\"#cite_note-SBDCC_BlogCost17-41\">[41]<\/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_42-0\" class=\"reference\"><a href=\"#cite_note-HiscoxHiscox19.22-42\">[42]<\/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_43-0\" class=\"reference\"><a href=\"#cite_note-Galvin60_18-43\">[43]<\/a><\/sup>\n<\/p><p>Food and beverage 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_44-0\" class=\"reference\"><a href=\"#cite_note-GrimaTop19-44\">[44]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MoenWhatHack16_45-0\" class=\"reference\"><a href=\"#cite_note-MoenWhatHack16-45\">[45]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-TalalevWebsite19_46-0\" class=\"reference\"><a href=\"#cite_note-TalalevWebsite19-46\">[46]<\/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 food and beverage 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_47-0\" class=\"reference\"><a href=\"#cite_note-NISTSecurity19-47\">[47]<\/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 food and beverage 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 test results, the safety of end users, and the promise of maintaining traceability across the utilized food 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 Codex Alimentarius CXS 234-1999 <i>Recommended Methods of Analysis and Sampling<\/i> to 21 CFR Part 120 (concerning hazard analysis and critical control point [HACCP] systems) and Safe Food for Canadians Regulations SOR\/2018-108, 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_48-0\" class=\"reference\"><a href=\"#cite_note-CiocoiuTheRole10-48\">[48]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-JPMorganData18_49-0\" class=\"reference\"><a href=\"#cite_note-JPMorganData18-49\">[49]<\/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_49-1\" class=\"reference\"><a href=\"#cite_note-JPMorganData18-49\">[49]<\/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_48-1\" class=\"reference\"><a href=\"#cite_note-CiocoiuTheRole10-48\">[48]<\/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 food and beverage 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 food authenticity and adulteration testing, does your existing laboratory informatics system\u2014or the ones you may be considering\u2014have the flexibility to add other types of food and beverage 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 food 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<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' costings. 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 the 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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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\">. 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Production management\"<\/a>. <i>LIMSpec 2022 R2<\/i>. LIMSwiki.org<span class=\"printonly\">. <a rel=\"nofollow\" class=\"external free\" href=\"#17._Production_management\">https:\/\/www.limswiki.org\/index.php?title=LII:LIMSpec\/Specialty_Laboratory_Functions#17._Production_management<\/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=17.+Production+management&rft.atitle=LIMSpec+2022+R2&rft.aulast=Douglas%2C+S.E.&rft.au=Douglas%2C+S.E.&rft.date=May+2022&rft.pub=LIMSwiki.org&rft_id=https%3A%2F%2Fwww.limswiki.org%2Findex.php%3Ftitle%3DLII%3ALIMSpec%2FSpecialty_Laboratory_Functions%2317._Production_management&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\"><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 Journal\">Chen, Xinyu; Voigt, Tobias (1 August 2020). \"Implementation of the Manufacturing Execution System in the food and beverage industry\" (in en). <i>Journal of Food Engineering<\/i> <b>278<\/b>: 109932. <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.2020.109932\" target=\"_blank\">10.1016\/j.jfoodeng.2020.109932<\/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=Implementation+of+the+Manufacturing+Execution+System+in+the+food+and+beverage+industry&rft.jtitle=Journal+of+Food+Engineering&rft.aulast=Chen&rft.aufirst=Xinyu&rft.au=Chen%2C%26%2332%3BXinyu&rft.au=Voigt%2C%26%2332%3BTobias&rft.date=1+August+2020&rft.volume=278&rft.pages=109932&rft_id=info:doi\/10.1016%2Fj.jfoodeng.2020.109932&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\"><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\">Kilcast, David; Subramaniam, Persis, eds. 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Oxford: WP, Woodhead Publ. <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=book&rft.btitle=Food+and+beverage+stability+and+shelf+life&rft.date=2011&rft.series=Woodhead+Publishing+series+in+food+science%2C+technology+and+nutrition&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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-35\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-35\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Wolinsky, Howard; Husted, Kristofor (1 March 2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/onlinelibrary.wiley.com\/doi\/10.15252\/embr.201540128\" target=\"_blank\">\"Science for food: Molecular biology contributes to the production and preparation of food\"<\/a> (in en). <i>EMBO reports<\/i> <b>16<\/b> (3): 272\u2013275. <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\/10.15252%2Fembr.201540128\" target=\"_blank\">10.15252\/embr.201540128<\/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\/1469-221X\" target=\"_blank\">1469-221X<\/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\/PMC4364866\/\" target=\"_blank\">PMC4364866<\/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\/25691389\" target=\"_blank\">25691389<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/onlinelibrary.wiley.com\/doi\/10.15252\/embr.201540128\" target=\"_blank\">https:\/\/onlinelibrary.wiley.com\/doi\/10.15252\/embr.201540128<\/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=Science+for+food%3A+Molecular+biology+contributes+to+the+production+and+preparation+of+food&rft.jtitle=EMBO+reports&rft.aulast=Wolinsky&rft.aufirst=Howard&rft.au=Wolinsky%2C%26%2332%3BHoward&rft.au=Husted%2C%26%2332%3BKristofor&rft.date=1+March+2015&rft.volume=16&rft.issue=3&rft.pages=272%E2%80%93275&rft_id=info:doi\/10.15252%2Fembr.201540128&rft.issn=1469-221X&rft_id=info:pmc\/PMC4364866&rft_id=info:pmid\/25691389&rft_id=https%3A%2F%2Fonlinelibrary.wiley.com%2Fdoi%2F10.15252%2Fembr.201540128&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-36\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-36\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Jayashree, B; 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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=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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HiscoxHiscox19.22-42\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HiscoxHiscox19.22_42-0\">\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). 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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=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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Galvin60_18-43\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Galvin60_18_43-0\">\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\">. 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=60+Percent+of+Small+Businesses+Fold+Within+6+Months+of+a+Cyber+Attack.+Here%27s+How+to+Protect+Yourself&rft.atitle=Inc.com&rft.aulast=Galvin%2C+J.&rft.au=Galvin%2C+J.&rft.date=7+May+2018&rft_id=https%3A%2F%2Fwww.inc.com%2Fjoe-galvin%2F60-percent-of-small-businesses-fold-within-6-months-of-a-cyber-attack-heres-how-to-protect-yourself.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GrimaTop19-44\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GrimaTop19_44-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Grima, M. (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\">. 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(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 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+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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-TalalevWebsite19-46\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-TalalevWebsite19_46-0\">\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 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=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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NISTSecurity19-47\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NISTSecurity19_47-0\">\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 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=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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CiocoiuTheRole10-48\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CiocoiuTheRole10_48-0\">48.0<\/a><\/sup> <sup><a href=\"#cite_ref-CiocoiuTheRole10_48-1\">48.1<\/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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JPMorganData18-49\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-JPMorganData18_49-0\">49.0<\/a><\/sup> <sup><a href=\"#cite_ref-JPMorganData18_49-1\">49.1<\/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 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=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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230110191213\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.365 seconds\nReal time usage: 0.379 seconds\nPreprocessor visited node count: 35460\/1000000\nPost\u2010expand include size: 296399\/2097152 bytes\nTemplate argument size: 91525\/2097152 bytes\nHighest expansion depth: 25\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 87106\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 333.495 1 -total\n 90.51% 301.836 1 Template:Reflist\n 75.32% 251.204 49 Template:Citation\/core\n 53.25% 177.579 35 Template:Cite_web\n 17.52% 58.421 10 Template:Cite_journal\n 12.50% 41.682 34 Template:Date\n 10.65% 35.520 4 Template:Cite_book\n 9.47% 31.583 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\n 5.75% 19.191 73 Template:Citation\/make_link\n 3.97% 13.246 23 Template:Citation\/identifier\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13930-0!canonical and timestamp 20230110191213 and revision id 50881. 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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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>","85c23189f7dd8f52181f96a16f048ed1_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/6\/6b\/FDA_Center_for_Food_Safety_%26_Applied_Nutrition_%28CFSAN%29_6536.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/8\/88\/FDA_Center_for_Food_Safety_%26_Applied_Nutrition_%28CFSAN%29_6496_%288756119526%29.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/5e\/Measuring_cybersecurity.png"],"85c23189f7dd8f52181f96a16f048ed1_timestamp":1673378970,"08f550c28fc5d4a453b2ab63b595ec29_type":"article","08f550c28fc5d4a453b2ab63b595ec29_title":"2.3 Other influencing factors","08f550c28fc5d4a453b2ab63b595ec29_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors","08f550c28fc5d4a453b2ab63b595ec29_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Standards and regulations affecting food and beverage labs\/Other influencing factorsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 2.3 Other influencing factors \n\n1.1 2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP) \n1.2 2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA) \n\n\n2 References \n3 Citation information for this chapter \n\n\n\n2.3 Other influencing factors \nSeveral other organized efforts towards better food quality are worth mentioning, often influencing the development of standards and regulations of other entities around the world.\n\n 2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP) \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.[1] The concept of GMP is often spoken of in terms of pharmaceutical and medical device manufacturing[1][2], though it is applicable to most any other production industry[3][4], including the food and beverage industry.[5][6]\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.[7][8] In the United States, cGMP\u2014in the context of food\u2014was first introduced 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.[9]\n\n 2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA) \nThe WHO's Nutrition and Food Safety (NFS) Department envisions \"a world free from all forms of malnutrition and foodborne diseases, within safe and supportive societies and healthy environments.\"[10] One way they attempt to make that vision a reality is through its SSA Unit, described as \"the focal point for WHO\u2019s work on international standard-setting in food safety and nutrition.\"[11] The SSA consists of a number of committees that develop scientific risk assessments and guidelines, which in turn make their way into the Codex Alimentarius and other national regulations and standards. These assessments and guidelines cover a variety of topics, including microbiological risk management, drug residues, food contaminates and additives, microplastics, and allergens, among others.[11]\n\nReferences \n\n\n\u2191 1.0 1.1 \"Good Manufacturing Practice (GMP) Resources\". International Society for Pharmaceutical Engineering, Inc. https:\/\/ispe.org\/initiatives\/regulatory-resources\/gmp . Retrieved 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 \"Good Manufacturing Practices for the 21st Century for Food Processing (2004 Study) Section 1: Current Food Good Manufacturing Practices\". U.S. Food and Drug Administration. 27 December 2017. https:\/\/www.who.int\/news-room\/questions-and-answers\/item\/medicines-good-manufacturing-processes .   \n \n\n\u2191 Manning (11 January 2013) (in en). Food & Drink - Good Manufacturing Practice: A Guide to its Responsible Management. Oxford, UK: Wiley-Blackwell. doi:10.1002\/9781118318225. ISBN 978-1-118-31822-5. http:\/\/doi.wiley.com\/10.1002\/9781118318225 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 \"Nutrition and Food Safety - Vision and Mission\". World Health Organization. https:\/\/www.who.int\/teams\/nutrition-and-food-safety\/overview . Retrieved 07 December 2022 .   \n \n\n\u2191 11.0 11.1 \"Nutrition and Food Safety - Standards and Scientific Advice on Food and Nutrition (SSA)\". World Health Organization. https:\/\/www.who.int\/teams\/nutrition-and-food-safety\/standards-and-scientific-advice-on-food-and-nutrition . 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: 2. Standards and regulations affecting food and beverage labs\nTitle: LIMS Selection Guide for Food Safety and Quality\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:11.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","08f550c28fc5d4a453b2ab63b595ec29_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Standards_and_regulations_affecting_food_and_beverage_labs_Other_influencing_factors rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Standards_and_regulations_affecting_food_and_beverage_labs_Other_influencing_factors 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 Food Safety and Quality\/Standards and regulations affecting food and beverage labs\/Other influencing factors<\/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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h3><span class=\"mw-headline\" id=\"2.3_Other_influencing_factors\">2.3 Other influencing factors<\/span><\/h3>\n<p>Several other organized efforts towards better food quality are worth mentioning, often influencing the development of standards and regulations of other entities around the world.\n<\/p>\n<h4><span id=\"rdp-ebb-2.3.1_Good_manufacturing_practice_(GMP)_and_current_good_manufacturing_practice_(cGMP)\"><\/span><span class=\"mw-headline\" id=\"2.3.1_Good_manufacturing_practice_.28GMP.29_and_current_good_manufacturing_practice_.28cGMP.29\">2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)<\/span><\/h4>\n<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_1-0\" class=\"reference\"><a href=\"#cite_note-ISPEGMP-1\">[1]<\/a><\/sup> The concept of GMP is often spoken of in terms of pharmaceutical and medical device manufacturing<sup id=\"rdp-ebb-cite_ref-ISPEGMP_1-1\" class=\"reference\"><a href=\"#cite_note-ISPEGMP-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WHOMedicines15_2-0\" class=\"reference\"><a href=\"#cite_note-WHOMedicines15-2\">[2]<\/a><\/sup>, though it is applicable to most any other production industry<sup id=\"rdp-ebb-cite_ref-CEReg07_3-0\" class=\"reference\"><a href=\"#cite_note-CEReg07-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FDAGMPCosm22_4-0\" class=\"reference\"><a href=\"#cite_note-FDAGMPCosm22-4\">[4]<\/a><\/sup>, including the food and beverage industry.<sup id=\"rdp-ebb-cite_ref-FDAGoodMan17_5-0\" class=\"reference\"><a href=\"#cite_note-FDAGoodMan17-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-6\" class=\"reference\"><a href=\"#cite_note-6\">[6]<\/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_7-0\" class=\"reference\"><a href=\"#cite_note-PSDiff21-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MoravekTheDiff_8-0\" class=\"reference\"><a href=\"#cite_note-MoravekTheDiff-8\">[8]<\/a><\/sup> In the United States, cGMP\u2014in the context of food\u2014was first introduced 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_9-0\" class=\"reference\"><a href=\"#cite_note-FDACurrentGood20-9\">[9]<\/a><\/sup>\n<\/p>\n<h4><span id=\"rdp-ebb-2.3.2_Standards_and_Scientific_Advice_on_Food_and_Nutrition_(SSA)\"><\/span><span class=\"mw-headline\" id=\"2.3.2_Standards_and_Scientific_Advice_on_Food_and_Nutrition_.28SSA.29\">2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)<\/span><\/h4>\n<p>The WHO's Nutrition and Food Safety (NFS) Department envisions \"a world free from all forms of malnutrition and foodborne diseases, within safe and supportive societies and healthy environments.\"<sup id=\"rdp-ebb-cite_ref-WHONFSHome_10-0\" class=\"reference\"><a href=\"#cite_note-WHONFSHome-10\">[10]<\/a><\/sup> One way they attempt to make that vision a reality is through its SSA Unit, described as \"the focal point for WHO\u2019s work on international standard-setting in food safety and nutrition.\"<sup id=\"rdp-ebb-cite_ref-WHONFS_SSA_11-0\" class=\"reference\"><a href=\"#cite_note-WHONFS_SSA-11\">[11]<\/a><\/sup> The SSA consists of a number of committees that develop scientific risk assessments and guidelines, which in turn make their way into the Codex Alimentarius and other national regulations and standards. These assessments and guidelines cover a variety of topics, including microbiological risk management, drug residues, food contaminates and additives, microplastics, and allergens, among others.<sup id=\"rdp-ebb-cite_ref-WHONFS_SSA_11-1\" class=\"reference\"><a href=\"#cite_note-WHONFS_SSA-11\">[11]<\/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-ISPEGMP-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ISPEGMP_1-0\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-ISPEGMP_1-1\">1.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ispe.org\/initiatives\/regulatory-resources\/gmp\" target=\"_blank\">\"Good Manufacturing Practice (GMP) Resources\"<\/a>. International Society for Pharmaceutical Engineering, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/ispe.org\/initiatives\/regulatory-resources\/gmp\" target=\"_blank\">https:\/\/ispe.org\/initiatives\/regulatory-resources\/gmp<\/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=Good+Manufacturing+Practice+%28GMP%29+Resources&rft.atitle=&rft.pub=International+Society+for+Pharmaceutical+Engineering%2C+Inc&rft_id=https%3A%2F%2Fispe.org%2Finitiatives%2Fregulatory-resources%2Fgmp&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WHOMedicines15-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WHOMedicines15_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/news-room\/questions-and-answers\/item\/medicines-good-manufacturing-processes\" target=\"_blank\">\"Medicines: Good manufacturing practices\"<\/a>. World Health Organization. 20 November 2015<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.who.int\/news-room\/questions-and-answers\/item\/medicines-good-manufacturing-processes\" target=\"_blank\">https:\/\/www.who.int\/news-room\/questions-and-answers\/item\/medicines-good-manufacturing-processes<\/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=Medicines%3A+Good+manufacturing+practices&rft.atitle=&rft.date=20+November+2015&rft.pub=World+Health+Organization&rft_id=https%3A%2F%2Fwww.who.int%2Fnews-room%2Fquestions-and-answers%2Fitem%2Fmedicines-good-manufacturing-processes&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CEReg07-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CEReg07_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><i>Control Engineering<\/i> Staff (14 July 2007). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.controleng.com\/articles\/regulated-or-not-know-good-manufacturing-practices-gmp\/\" target=\"_blank\">\"Regulated or not? 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 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=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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FDAGMPCosm22-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FDAGMPCosm22_4-0\">\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\">. 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=Good+Manufacturing+Practice+%28GMP%29+Guidelines%2FInspection+Checklist+for+Cosmetics&rft.atitle=&rft.date=25+February+2022&rft.pub=U.S.+Food+and+Drug+Administration&rft_id=https%3A%2F%2Fwww.fda.gov%2Fcosmetics%2Fcosmetics-guidance-documents%2Fgood-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FDAGoodMan17-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FDAGoodMan17_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/news-room\/questions-and-answers\/item\/medicines-good-manufacturing-processes\" target=\"_blank\">\"Good Manufacturing Practices for the 21st Century for Food Processing (2004 Study) Section 1: Current Food Good Manufacturing Practices\"<\/a>. U.S. Food and Drug Administration. 27 December 2017<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.who.int\/news-room\/questions-and-answers\/item\/medicines-good-manufacturing-processes\" target=\"_blank\">https:\/\/www.who.int\/news-room\/questions-and-answers\/item\/medicines-good-manufacturing-processes<\/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=Good+Manufacturing+Practices+for+the+21st+Century+for+Food+Processing+%282004+Study%29+Section+1%3A+Current+Food+Good+Manufacturing+Practices&rft.atitle=&rft.date=27+December+2017&rft.pub=U.S.+Food+and+Drug+Administration&rft_id=https%3A%2F%2Fwww.who.int%2Fnews-room%2Fquestions-and-answers%2Fitem%2Fmedicines-good-manufacturing-processes&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors\"><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 book\">Manning (11 January 2013) (in en). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/doi.wiley.com\/10.1002\/9781118318225\" target=\"_blank\"><i>Food & Drink - Good Manufacturing Practice: A Guide to its Responsible Management<\/i><\/a>. Oxford, UK: Wiley-Blackwell. <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%2F9781118318225\" target=\"_blank\">10.1002\/9781118318225<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-1-118-31822-5<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/doi.wiley.com\/10.1002\/9781118318225\" target=\"_blank\">http:\/\/doi.wiley.com\/10.1002\/9781118318225<\/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+%26+Drink+-+Good+Manufacturing+Practice%3A+A+Guide+to+its+Responsible+Management&rft.aulast=Manning&rft.au=Manning&rft.date=11+January+2013&rft.place=Oxford%2C+UK&rft.pub=Wiley-Blackwell&rft_id=info:doi\/10.1002%2F9781118318225&rft.isbn=978-1-118-31822-5&rft_id=http%3A%2F%2Fdoi.wiley.com%2F10.1002%2F9781118318225&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PSDiff21-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PSDiff21_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"nofollow\" class=\"external text\" href=\"#gsc.tab=0\">\"Difference Between GMP and cGMP\"<\/a>. <i>Pharma Specialists<\/i>. 13 October 2021<span class=\"printonly\">. <a rel=\"nofollow\" class=\"external free\" href=\"#gsc.tab=0\">https:\/\/www.pharmaspecialists.com\/2021\/10\/difference-between-gmp-and-cgmp.html#gsc.tab=0<\/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=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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MoravekTheDiff-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MoravekTheDiff_8-0\">\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\">. 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=The+Differences+Between+GMP+and+cGMP&rft.atitle=Moravek+Blog&rft.date=January+2021&rft.pub=Moravek%2C+Inc&rft_id=https%3A%2F%2Fwww.moravek.com%2Fthe-differences-between-gmp-and-cgmp%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FDACurrentGood20-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FDACurrentGood20_9-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/guidance-regulation-food-and-dietary-supplements\/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements\" target=\"_blank\">\"Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements\"<\/a>. U.S. Food and Drug Administration. 31 January 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fda.gov\/food\/guidance-regulation-food-and-dietary-supplements\/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements\" target=\"_blank\">https:\/\/www.fda.gov\/food\/guidance-regulation-food-and-dietary-supplements\/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements<\/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=Current+Good+Manufacturing+Practices+%28CGMPs%29+for+Food+and+Dietary+Supplements&rft.atitle=&rft.date=31+January+2020&rft.pub=U.S.+Food+and+Drug+Administration&rft_id=https%3A%2F%2Fwww.fda.gov%2Ffood%2Fguidance-regulation-food-and-dietary-supplements%2Fcurrent-good-manufacturing-practices-cgmps-food-and-dietary-supplements&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WHONFSHome-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WHONFSHome_10-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/teams\/nutrition-and-food-safety\/overview\" target=\"_blank\">\"Nutrition and Food Safety - Vision and Mission\"<\/a>. World Health Organization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.who.int\/teams\/nutrition-and-food-safety\/overview\" target=\"_blank\">https:\/\/www.who.int\/teams\/nutrition-and-food-safety\/overview<\/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=Nutrition+and+Food+Safety+-+Vision+and+Mission&rft.atitle=&rft.pub=World+Health+Organization&rft_id=https%3A%2F%2Fwww.who.int%2Fteams%2Fnutrition-and-food-safety%2Foverview&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WHONFS_SSA-11\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-WHONFS_SSA_11-0\">11.0<\/a><\/sup> <sup><a href=\"#cite_ref-WHONFS_SSA_11-1\">11.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/teams\/nutrition-and-food-safety\/standards-and-scientific-advice-on-food-and-nutrition\" target=\"_blank\">\"Nutrition and Food Safety - Standards and Scientific Advice on Food and Nutrition (SSA)\"<\/a>. World Health Organization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.who.int\/teams\/nutrition-and-food-safety\/standards-and-scientific-advice-on-food-and-nutrition\" target=\"_blank\">https:\/\/www.who.int\/teams\/nutrition-and-food-safety\/standards-and-scientific-advice-on-food-and-nutrition<\/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=Nutrition+and+Food+Safety+-+Standards+and+Scientific+Advice+on+Food+and+Nutrition+%28SSA%29&rft.atitle=&rft.pub=World+Health+Organization&rft_id=https%3A%2F%2Fwww.who.int%2Fteams%2Fnutrition-and-food-safety%2Fstandards-and-scientific-advice-on-food-and-nutrition&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors\"><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_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Choosing laboratory informatics software for your food and beverage lab\/Evaluation and selection\" class=\"wiki-link\" data-key=\"85c23189f7dd8f52181f96a16f048ed1\">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 food and beverage labs\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for Food Safety and Quality<\/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>: January 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230110191328\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.096 seconds\nReal time usage: 0.103 seconds\nPreprocessor visited node count: 7382\/1000000\nPost\u2010expand include size: 57296\/2097152 bytes\nTemplate argument size: 20986\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 18100\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 93.695 1 -total\n 88.51% 82.927 1 Template:Reflist\n 67.25% 63.011 11 Template:Citation\/core\n 59.97% 56.188 10 Template:Cite_web\n 15.98% 14.977 1 Template:Cite_book\n 12.75% 11.947 8 Template:Date\n 11.37% 10.655 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors\n 6.64% 6.221 2 Template:Citation\/identifier\n 4.22% 3.949 14 Template:Citation\/make_link\n 1.90% 1.782 2 Template:Only_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13929-0!canonical and timestamp 20230110191328 and revision id 50880. 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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors<\/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>","08f550c28fc5d4a453b2ab63b595ec29_images":[],"08f550c28fc5d4a453b2ab63b595ec29_timestamp":1673378970,"56966df6cf92be2a7ac590d34a57bd6e_type":"article","56966df6cf92be2a7ac590d34a57bd6e_title":"2.2 Regulations and laws around the world","56966df6cf92be2a7ac590d34a57bd6e_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Regulations_and_laws_around_the_world","56966df6cf92be2a7ac590d34a57bd6e_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Standards and regulations affecting food and beverage 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 Safety Act 1990 and Food Standards Act 1999 - United Kingdom \n1.2 2.2.2 Food Safety and Standards Act of 2006 - India \n1.3 2.2.3 Food Safety Law - China \n1.4 2.2.4 Food Sanitation Act and Food Safety Basic Act - Japan \n1.5 2.2.5 Food Safety Modernization Act (FSMA) and other acts - United States \n1.6 2.2.6 General Food Law Regulation (GFLR) - European Union \n1.7 2.2.7 Safe Food for Canadians Act (SFCA) - Canada \n\n\n2 References \n\n\n\n2.2 Regulations and laws around the world \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 FAQ 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[1][2][3], which should not be surprising given the cultural, political, and functional differences across regions and nations of the world.[1]\n\n2.2.1 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.[4][5] 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.[4][5] 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.\"[6] 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 labelling policy.[7] 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.[8]\n\n2.2.2 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.[9][10] 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.[9] 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.[10]\n\n2.2.3 Food Safety Law - China \nThe Food Safety Law is described as \"the fundamental law regulating food safety in China.\"[11] 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.\"[11] Among these activities, the Law describes how food testing laboratories shall conduct their activities, from accreditation and sampling to testing and reporting.[12]\n\n2.2.4 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.\"[13] 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.[14] 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.[15]\n\n 2.2.5 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.[16][17] It has been described by the FDA as \"the most sweeping reform of our food safety laws in more than 70 years.\"[17] 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.[17] 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).[18]\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.[19] The FSIS has developed its own regulatory requirements for meat, poultry, and egg products, including for inspections, imports and exports, labeling, and laboratory testing.[20][21][22]\n\n 2.2.6 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.[23] 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.[16][23] As such, the EFSA develops broad and sector-specific guidance[24], 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.[25] 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.\"[26]\n\n 2.2.7 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.\"[27][28] Though Canadian Food Inspection Agency (CFIA) enforcement of the SFCA's regulations didn't start until January 2019[27], 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.[29] 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.[29]\n\nReferences \n\n\n\u2191 1.0 1.1 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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 4.0 4.1 \"Food safety regulations\". Scarborough Borough Council. 10 November 2022. https:\/\/www.scarborough.gov.uk\/home\/business-licensing-and-grants\/food-hygeine\/food-safety-regulations . Retrieved 07 December 2022 .   \n \n\n\u2191 5.0 5.1 \"Key regulations\". Food Standards Agency. 30 August 2022. https:\/\/www.food.gov.uk\/about-us\/key-regulations . Retrieved 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 \"Food Standards Agency\". Gov.uk. https:\/\/www.gov.uk\/government\/organisations\/food-standards-agency . Retrieved 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 9.0 9.1 \"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 07 December 2022 .   \n \n\n\u2191 10.0 10.1 \"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 07 December 2022 .   \n \n\n\u2191 11.0 11.1 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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 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 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 16.0 16.1 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 17.0 17.1 17.2 \"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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 23.0 23.1 \"General Food Law\". Food Safety. European Commission. https:\/\/food.ec.europa.eu\/horizontal-topics\/general-food-law_en . Retrieved 07 December 2022 .   \n \n\n\u2191 \"Guidance and other assessment methodology documents\". European Food Safety Authority. https:\/\/www.efsa.europa.eu\/en\/methodology\/guidance . Retrieved 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 27.0 27.1 \"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 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 29.0 29.1 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\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Regulations_and_laws_around_the_world\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Regulations_and_laws_around_the_world<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:10.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","56966df6cf92be2a7ac590d34a57bd6e_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Standards_and_regulations_affecting_food_and_beverage_labs_Regulations_and_laws_around_the_world rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Standards_and_regulations_affecting_food_and_beverage_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 Food Safety and Quality\/Standards and regulations affecting food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">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>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 FAQ 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<sup id=\"rdp-ebb-cite_ref-BuzbyFood03_1-0\" class=\"reference\"><a href=\"#cite_note-BuzbyFood03-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GAOFoodSafety05_2-0\" class=\"reference\"><a href=\"#cite_note-GAOFoodSafety05-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WhitworthReport22_3-0\" class=\"reference\"><a href=\"#cite_note-WhitworthReport22-3\">[3]<\/a><\/sup>, 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_1-1\" class=\"reference\"><a href=\"#cite_note-BuzbyFood03-1\">[1]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.2.1_Food_Safety_Act_1990_and_Food_Standards_Act_1999_-_United_Kingdom\">2.2.1 Food Safety Act 1990 and Food Standards Act 1999 - <i>United Kingdom<\/i><\/span><\/h4>\n<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_4-0\" class=\"reference\"><a href=\"#cite_note-SBCFood22-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FSAKey22_5-0\" class=\"reference\"><a href=\"#cite_note-FSAKey22-5\">[5]<\/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_4-1\" class=\"reference\"><a href=\"#cite_note-SBCFood22-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FSAKey22_5-1\" class=\"reference\"><a href=\"#cite_note-FSAKey22-5\">[5]<\/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_6-0\" class=\"reference\"><a href=\"#cite_note-FSA99Sec1-6\">[6]<\/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 labelling policy.<sup id=\"rdp-ebb-cite_ref-FSAAbout_7-0\" class=\"reference\"><a href=\"#cite_note-FSAAbout-7\">[7]<\/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_8-0\" class=\"reference\"><a href=\"#cite_note-FSAGuidReg-8\">[8]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.2.2_Food_Safety_and_Standards_Act_of_2006_-_India\">2.2.2 Food Safety and Standards Act of 2006 - <i>India<\/i><\/span><\/h4>\n<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_9-0\" class=\"reference\"><a href=\"#cite_note-PRSImplement-9\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FSSAIFood_10-0\" class=\"reference\"><a href=\"#cite_note-FSSAIFood-10\">[10]<\/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_9-1\" class=\"reference\"><a href=\"#cite_note-PRSImplement-9\">[9]<\/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_10-1\" class=\"reference\"><a href=\"#cite_note-FSSAIFood-10\">[10]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.2.3_Food_Safety_Law_-_China\">2.2.3 Food Safety Law - <i>China<\/i><\/span><\/h4>\n<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_11-0\" class=\"reference\"><a href=\"#cite_note-UNEPFood15-11\">[11]<\/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_11-1\" class=\"reference\"><a href=\"#cite_note-UNEPFood15-11\">[11]<\/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_12-0\" class=\"reference\"><a href=\"#cite_note-USDAChina15-12\">[12]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.2.4_Food_Sanitation_Act_and_Food_Safety_Basic_Act_-_Japan\">2.2.4 Food Sanitation Act and Food Safety Basic Act - <i>Japan<\/i><\/span><\/h4>\n<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_13-0\" class=\"reference\"><a href=\"#cite_note-JLTFood47-13\">[13]<\/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_14-0\" class=\"reference\"><a href=\"#cite_note-FSCFoodSafe03-14\">[14]<\/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_15-0\" class=\"reference\"><a href=\"#cite_note-BMFoodJapan18-15\">[15]<\/a><\/sup>\n<\/p>\n<h4><span id=\"rdp-ebb-2.2.5_Food_Safety_Modernization_Act_(FSMA)_and_other_acts_-_United_States\"><\/span><span class=\"mw-headline\" id=\"2.2.5_Food_Safety_Modernization_Act_.28FSMA.29_and_other_acts_-_United_States\">2.2.5 Food Safety Modernization Act (FSMA) and other acts - <i>United States<\/i><\/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 <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_16-0\" class=\"reference\"><a href=\"#cite_note-WeinrothHist18-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FDAFood22_17-0\" class=\"reference\"><a href=\"#cite_note-FDAFood22-17\">[17]<\/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_17-1\" class=\"reference\"><a href=\"#cite_note-FDAFood22-17\">[17]<\/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_17-2\" class=\"reference\"><a href=\"#cite_note-FDAFood22-17\">[17]<\/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_18-0\" class=\"reference\"><a href=\"#cite_note-FDAFSMA22-18\">[18]<\/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_19-0\" class=\"reference\"><a href=\"#cite_note-USDAOurHist18-19\">[19]<\/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_20-0\" class=\"reference\"><a href=\"#cite_note-9CFR412-20\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FSISFedReg_21-0\" class=\"reference\"><a href=\"#cite_note-FSISFedReg-21\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NALFoodSafe_22-0\" class=\"reference\"><a href=\"#cite_note-NALFoodSafe-22\">[22]<\/a><\/sup>\n<\/p>\n<h4><span id=\"rdp-ebb-2.2.6_General_Food_Law_Regulation_(GFLR)_-_European_Union\"><\/span><span class=\"mw-headline\" id=\"2.2.6_General_Food_Law_Regulation_.28GFLR.29_-_European_Union\">2.2.6 General Food Law Regulation (GFLR) - <i>European Union<\/i><\/span><\/h4>\n<p>The 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_23-0\" class=\"reference\"><a href=\"#cite_note-EUGeneral-23\">[23]<\/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_16-1\" class=\"reference\"><a href=\"#cite_note-WeinrothHist18-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EUGeneral_23-1\" class=\"reference\"><a href=\"#cite_note-EUGeneral-23\">[23]<\/a><\/sup> As such, the EFSA develops broad and sector-specific guidance<sup id=\"rdp-ebb-cite_ref-EFSAGuidance_24-0\" class=\"reference\"><a href=\"#cite_note-EFSAGuidance-24\">[24]<\/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_25-0\" class=\"reference\"><a href=\"#cite_note-EU2073-2005-25\">[25]<\/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_26-0\" class=\"reference\"><a href=\"#cite_note-EFSAFoodClass-26\">[26]<\/a><\/sup>\n<\/p>\n<h4><span id=\"rdp-ebb-2.2.7_Safe_Food_for_Canadians_Act_(SFCA)_-_Canada\"><\/span><span class=\"mw-headline\" id=\"2.2.7_Safe_Food_for_Canadians_Act_.28SFCA.29_-_Canada\">2.2.7 Safe Food for Canadians Act (SFCA) - <i>Canada<\/i><\/span><\/h4>\n<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_27-0\" class=\"reference\"><a href=\"#cite_note-ManitobaSafe-27\">[27]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-JLWSafeFood19_28-0\" class=\"reference\"><a href=\"#cite_note-JLWSafeFood19-28\">[28]<\/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_27-1\" class=\"reference\"><a href=\"#cite_note-ManitobaSafe-27\">[27]<\/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_29-0\" class=\"reference\"><a href=\"#cite_note-GoCUnder18-29\">[29]<\/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_29-1\" class=\"reference\"><a href=\"#cite_note-GoCUnder18-29\">[29]<\/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-BuzbyFood03-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BuzbyFood03_1-0\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-BuzbyFood03_1-1\">1.1<\/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 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=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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GAOFoodSafety05-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GAOFoodSafety05_2-0\">\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 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=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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WhitworthReport22-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WhitworthReport22_3-0\">\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\">. 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Scarborough Borough Council. 10 November 2022<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.scarborough.gov.uk\/home\/business-licensing-and-grants\/food-hygeine\/food-safety-regulations\" target=\"_blank\">https:\/\/www.scarborough.gov.uk\/home\/business-licensing-and-grants\/food-hygeine\/food-safety-regulations<\/a><\/span><span class=\"reference-accessdate\">. 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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=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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ManitobaSafe-27\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ManitobaSafe_27-0\">27.0<\/a><\/sup> <sup><a href=\"#cite_ref-ManitobaSafe_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.gov.mb.ca\/agriculture\/food-safety\/at-the-food-processor\/safe-food-for-canadians-act.html\" target=\"_blank\">\"Safe Food for Canadians Act\"<\/a>. Manitoba Government<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.gov.mb.ca\/agriculture\/food-safety\/at-the-food-processor\/safe-food-for-canadians-act.html\" target=\"_blank\">https:\/\/www.gov.mb.ca\/agriculture\/food-safety\/at-the-food-processor\/safe-food-for-canadians-act.html<\/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=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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JLWSafeFood19-28\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-JLWSafeFood19_28-0\">\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>. Government of Canada. 17 June 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/acts\/s-1.1\/index.html\" target=\"_blank\">https:\/\/laws-lois.justice.gc.ca\/eng\/acts\/s-1.1\/index.html<\/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=Safe+Food+for+Canadians+Act+%28S.C.+2012%2C+c.+24%29&rft.atitle=Justice+Laws+Website&rft.date=17+June+2019&rft.pub=Government+of+Canada&rft_id=https%3A%2F%2Flaws-lois.justice.gc.ca%2Feng%2Facts%2Fs-1.1%2Findex.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GoCUnder18-29\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-GoCUnder18_29-0\">29.0<\/a><\/sup> <sup><a href=\"#cite_ref-GoCUnder18_29-1\">29.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Canadian Food Inspection Agency (2018). <a rel=\"external_link\" class=\"external text\" 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\"><i>Understanding the Safe Food for Canadians Regulations: A handbook for food businesses<\/i><\/a>. 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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Regulations_and_laws_around_the_world\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230110191038\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.214 seconds\nReal time usage: 0.223 seconds\nPreprocessor visited node count: 19342\/1000000\nPost\u2010expand include size: 148155\/2097152 bytes\nTemplate argument size: 50858\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 48584\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 200.175 1 -total\n 90.69% 181.537 1 Template:Reflist\n 72.57% 145.259 29 Template:Citation\/core\n 67.71% 135.548 27 Template:Cite_web\n 12.01% 24.035 17 Template:Date\n 9.27% 18.563 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Regulations_and_laws_around_the_world\n 8.83% 17.678 1 Template:Cite_journal\n 4.57% 9.151 43 Template:Citation\/make_link\n 3.94% 7.890 1 Template:Cite_book\n 3.88% 7.760 5 Template:Citation\/identifier\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13928-0!canonical and timestamp 20230110191039 and revision id 50879. 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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Regulations_and_laws_around_the_world\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_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>","56966df6cf92be2a7ac590d34a57bd6e_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/b2\/Food-safety-modernization-act-fsma.png"],"56966df6cf92be2a7ac590d34a57bd6e_timestamp":1673378970,"e3e9feec19733f9743b173dea0d9991c_type":"article","e3e9feec19733f9743b173dea0d9991c_title":"2.1 Globally recognized food safety standards","e3e9feec19733f9743b173dea0d9991c_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards","e3e9feec19733f9743b173dea0d9991c_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Standards and regulations affecting food and beverage labs\/Globally recognized food safety standardsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 2. Standards and regulations affecting food and beverage labs \n\n1.1 2.1 Globally recognized food safety standards \n\n1.1.1 2.1.1 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS) \n1.1.2 2.1.2 Codex Alimentarius \n1.1.3 2.1.3 Global Food Safety Initiative (GFSI) \n1.1.4 2.1.4 Hazard analysis and critical control points (HACCP) \n1.1.5 2.1.5 International Featured Standards (IFS) \n1.1.6 2.1.6 International Organization for Standardization (ISO) 22000 \n1.1.7 2.1.8 Safe Quality Food (SQF) Program \n\n\n\n\n2 References \n\n\n\n2. Standards and regulations affecting food and beverage labs \nSocieties around the world have grown to expect and depend on high-quality, nutritious foods and beverages, whether coming directly from a farm or being produced by a food and beverage manufacturer. With the history of food and beverage safety having a somewhat checkered past until the early twentieth century[1], this expectation hasn't always been easy to meet. However, with better understanding of food safety and greater efforts to standardize and regulate it, governments and producers have improved food quality and safety into the twenty-first century. Yet any assurances coming from these efforts to standardize and regulate are dependent upon rigorous and validated methods not only in the production facility but also in any laboratory making analyses for the facility. \nThis chapter will briefly examine the standards, regulations, guidance, and other factors globally driven by not only the demand for safer foods and beverages, but also that in many cases dictate what and how quality activities are conducted towards ensuring food safety around the world inside and outside the food and beverage laboratory.\n\r\n\n\n2.1 Globally recognized food safety standards \nLike other industries, the food and beverage industry depends on well-defined and -justified standards to better ensure the quality of their products. Implementing and maintaining conformance to internationally recognized and benchmarked food safety standards benefits the food and beverage organization in a number of ways[2][3]:\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 food safety management practices.\nIt enables organizations to better demonstrate auditable compliance with modern food safety management practices.\nIt allows organizations to limit product recalls, reduce customer complaints, and better protect their brand.\nAs such, 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\n 2.1.1 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.[2][3][4][5] The standard is implemented by an organization through gap assessment, documentation development, consultation and assessment, internal auditing, and resolving non-conformances to the standard.[3] \n\n2.1.2 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).[4] 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.\"[6] Scope of the standards is broad, covering food hygiene; food additives and contaminants, including pesticides and drugs; packaging and labelling; sampling and analysis methods; and import and export inspection and certification.[6] It's not unusual for governments to approach the FAO seeking help with harmonizing national legal frameworks of food safety with the Codex Alimentarius.[7] Among the Codex, some of the more broadly useful standards include General Principles of Food Hygiene (CXC 1-1969)[8], General Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995), and General Methods of Analysis for Contaminants (CXS 228-2001).[9]\n\n 2.1.3 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.[4] Previously known as the GFSI Guidance Document[10], 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.\"[4] 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.[11] GFSI is also responsible for ensuring CPOs and certification bodies meet the necessary requirements.\n\n 2.1.4 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[12], 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.[4] 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.[12][13] HACCP also found its way into other standards benchmarked by the GFSI.[12] The concept of HACCP has perhaps changed slightly over the years, but the main principles remain[4]:\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.\n 2.1.5 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\"[14] or \"uniform evaluation system\"[4] 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]\n\n 2.1.6 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.[12] 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]\n 2.1.8 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.[4] 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\nReferences \n\n\n\u2191 Douglas, S.E. (August 2022). \"LIMS FAQ:What is the importance of a food and beverage testing laboratory to society?\". LIMSwiki. https:\/\/www.limswiki.org\/index.php\/LIMS_FAQ:What_is_the_importance_of_a_food_and_beverage_testing_laboratory_to_society? . Retrieved 02 December 2022 .   \n \n\n\u2191 2.0 2.1 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 07 December 2022 .   \n \n\n\u2191 3.0 3.1 3.2 \"BRCGS - British Retail Consortium Global Standard\" (PDF). Perry Johnson Food Safety Consulting, Inc. April 2020. https:\/\/www.pjfsc.com\/Downloads\/BRC-Overview.pdf . Retrieved 07 December 2022 .   \n \n\n\u2191 4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7 \"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 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 6.0 6.1 \"About Codex Alimentarius\". Food and Agricultural Organization. 2022. https:\/\/www.fao.org\/fao-who-codexalimentarius\/about-codex\/en\/#c453333 . Retrieved 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 \"Contaminants\". Codex Alimentarius. Food and Agricultural Organization. 2022. https:\/\/www.fao.org\/fao-who-codexalimentarius\/thematic-areas\/contaminants\/en\/ . Retrieved 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 \"Certification\". Global Food Safety Initiative. 2022. https:\/\/mygfsi.com\/how-to-implement\/certification\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 12.0 12.1 12.2 12.3 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 07 December 2022 .   \n \n\n\u2191 \"IFS: Global Safety and Quality Standards\". IFS Management GmbH. https:\/\/www.ifs-certification.com\/index.php\/en\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 \"IFS Standards\". IFS Management GmbH. https:\/\/www.ifs-certification.com\/index.php\/en\/standards . Retrieved 07 December 2022 .   \n \n\n\u2191 \"ISO 22000 Food safety management\". International Organization for Standardization. https:\/\/www.iso.org\/iso-22000-food-safety-management.html . Retrieved 07 December 2022 .   \n \n\n\u2191 \"ISO\/TC34\/SC17\". International Organization for Standardization. https:\/\/committee.iso.org\/home\/tc34sc17 . Retrieved 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 07 December 2022 .   \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 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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:10.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","e3e9feec19733f9743b173dea0d9991c_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Standards_and_regulations_affecting_food_and_beverage_labs_Globally_recognized_food_safety_standards rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Standards_and_regulations_affecting_food_and_beverage_labs_Globally_recognized_food_safety_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 Food Safety and Quality\/Standards and regulations affecting food and beverage labs\/Globally recognized food safety 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h2><span class=\"mw-headline\" id=\"2._Standards_and_regulations_affecting_food_and_beverage_labs\">2. Standards and regulations affecting food and beverage labs<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Food_Safety_Tips.jpg\" class=\"image wiki-link\" data-key=\"8b6f21e0b165afd2c1b25a33260a2675\"><img alt=\"Food Safety Tips.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/d\/d0\/Food_Safety_Tips.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>Societies around the world have grown to expect and depend on high-quality, nutritious foods and beverages, whether coming directly from a farm or being produced by a food and beverage manufacturer. With the history of food and beverage safety having a somewhat checkered past until the early twentieth century<sup id=\"rdp-ebb-cite_ref-DouglasImportance22_1-0\" class=\"reference\"><a href=\"#cite_note-DouglasImportance22-1\">[1]<\/a><\/sup>, this expectation hasn't always been easy to meet. However, with better understanding of food safety and greater efforts to standardize and regulate it, governments and producers have improved food quality and safety into the twenty-first century. Yet any assurances coming from these efforts to standardize and regulate are dependent upon rigorous and validated methods not only in the production facility but also in any <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> making analyses for the facility. \n<\/p><p>This chapter will briefly examine the standards, regulations, guidance, and other factors globally driven by not only the demand for safer foods and beverages, but also that in many cases dictate what and how quality activities are conducted towards ensuring food safety around the world inside and outside the food and beverage laboratory.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"2.1_Globally_recognized_food_safety_standards\">2.1 Globally recognized food safety standards<\/span><\/h3>\n<p>Like other industries, the food and beverage industry depends on well-defined and -justified standards to better ensure the quality of their products. Implementing and maintaining conformance to internationally recognized and benchmarked food safety standards benefits the food and beverage organization in a number of ways<sup id=\"rdp-ebb-cite_ref-Pavlovi.C4.87What17_2-0\" class=\"reference\"><a href=\"#cite_note-Pavlovi.C4.87What17-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PJBRCGS20_3-0\" class=\"reference\"><a href=\"#cite_note-PJBRCGS20-3\">[3]<\/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 food safety management practices.<\/li>\n<li>It enables organizations to better demonstrate auditable compliance with modern food 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, 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>\n<h4><span id=\"rdp-ebb-2.1.1_British_Retail_Consortium_(BRC)_Global_Standard_for_Food_Safety_(GSFS)\"><\/span><span class=\"mw-headline\" id=\"2.1.1_British_Retail_Consortium_.28BRC.29_Global_Standard_for_Food_Safety_.28GSFS.29\">2.1.1 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)<\/span><\/h4>\n<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_2-1\" class=\"reference\"><a href=\"#cite_note-Pavlovi.C4.87What17-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PJBRCGS20_3-1\" class=\"reference\"><a href=\"#cite_note-PJBRCGS20-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EagleFood19_4-0\" class=\"reference\"><a href=\"#cite_note-EagleFood19-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BRCGSFS8_18_5-0\" class=\"reference\"><a href=\"#cite_note-BRCGSFS8_18-5\">[5]<\/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_3-2\" class=\"reference\"><a href=\"#cite_note-PJBRCGS20-3\">[3]<\/a><\/sup> \n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.1.2_Codex_Alimentarius\">2.1.2 Codex Alimentarius<\/span><\/h4>\n<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_4-1\" class=\"reference\"><a href=\"#cite_note-EagleFood19-4\">[4]<\/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_6-0\" class=\"reference\"><a href=\"#cite_note-FAOCodexAbout-6\">[6]<\/a><\/sup> Scope of the standards is broad, covering food hygiene; food additives and contaminants, including pesticides and drugs; packaging and labelling; sampling and analysis methods; and import and export inspection and certification.<sup id=\"rdp-ebb-cite_ref-FAOCodexAbout_6-1\" class=\"reference\"><a href=\"#cite_note-FAOCodexAbout-6\">[6]<\/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_7-0\" class=\"reference\"><a href=\"#cite_note-FOAFood22-7\">[7]<\/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_8-0\" class=\"reference\"><a href=\"#cite_note-FAOCodes22-8\">[8]<\/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_9-0\" class=\"reference\"><a href=\"#cite_note-FAOContam22-9\">[9]<\/a><\/sup>\n<\/p>\n<h4><span id=\"rdp-ebb-2.1.3_Global_Food_Safety_Initiative_(GFSI)\"><\/span><span class=\"mw-headline\" id=\"2.1.3_Global_Food_Safety_Initiative_.28GFSI.29\">2.1.3 Global Food Safety Initiative (GFSI)<\/span><\/h4>\n<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_4-2\" class=\"reference\"><a href=\"#cite_note-EagleFood19-4\">[4]<\/a><\/sup> Previously known as the GFSI Guidance Document<sup id=\"rdp-ebb-cite_ref-GFSIRelease17_10-0\" class=\"reference\"><a href=\"#cite_note-GFSIRelease17-10\">[10]<\/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_4-3\" class=\"reference\"><a href=\"#cite_note-EagleFood19-4\">[4]<\/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_11-0\" class=\"reference\"><a href=\"#cite_note-GFSICert22-11\">[11]<\/a><\/sup> GFSI is also responsible for ensuring CPOs and certification bodies meet the necessary requirements.\n<\/p>\n<h4><span id=\"rdp-ebb-2.1.4_Hazard_analysis_and_critical_control_points_(HACCP)\"><\/span><span class=\"mw-headline\" id=\"2.1.4_Hazard_analysis_and_critical_control_points_.28HACCP.29\">2.1.4 Hazard analysis and critical control points (HACCP)<\/span><\/h4>\n<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_12-0\" class=\"reference\"><a href=\"#cite_note-WeinrothHist18-12\">[12]<\/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_4-4\" class=\"reference\"><a href=\"#cite_note-EagleFood19-4\">[4]<\/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_12-1\" class=\"reference\"><a href=\"#cite_note-WeinrothHist18-12\">[12]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-61FR38806_13-0\" class=\"reference\"><a href=\"#cite_note-61FR38806-13\">[13]<\/a><\/sup> HACCP also found its way into other standards benchmarked by the GFSI.<sup id=\"rdp-ebb-cite_ref-WeinrothHist18_12-2\" class=\"reference\"><a href=\"#cite_note-WeinrothHist18-12\">[12]<\/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_4-5\" class=\"reference\"><a href=\"#cite_note-EagleFood19-4\">[4]<\/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<h4><span id=\"rdp-ebb-2.1.5_International_Featured_Standards_(IFS)\"><\/span><span class=\"mw-headline\" id=\"2.1.5_International_Featured_Standards_.28IFS.29\">2.1.5 International Featured Standards (IFS)<\/span><\/h4>\n<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_14-0\" class=\"reference\"><a href=\"#cite_note-IFSHome-14\">[14]<\/a><\/sup> or \"uniform evaluation system\"<sup id=\"rdp-ebb-cite_ref-EagleFood19_4-6\" class=\"reference\"><a href=\"#cite_note-EagleFood19-4\">[4]<\/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-IFSStandards_15-0\" class=\"reference\"><a href=\"#cite_note-IFSStandards-15\">[15]<\/a><\/sup>\n<\/p>\n<h4><span id=\"rdp-ebb-2.1.6_International_Organization_for_Standardization_(ISO)_22000\"><\/span><span class=\"mw-headline\" id=\"2.1.6_International_Organization_for_Standardization_.28ISO.29_22000\">2.1.6 International Organization for Standardization (ISO) 22000<\/span><\/h4>\n<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_12-3\" class=\"reference\"><a href=\"#cite_note-WeinrothHist18-12\">[12]<\/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<h4><span id=\"rdp-ebb-2.1.8_Safe_Quality_Food_(SQF)_Program\"><\/span><span class=\"mw-headline\" id=\"2.1.8_Safe_Quality_Food_.28SQF.29_Program\">2.1.8 Safe Quality Food (SQF) Program<\/span><\/h4>\n<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_4-7\" class=\"reference\"><a href=\"#cite_note-EagleFood19-4\">[4]<\/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<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-DouglasImportance22-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DouglasImportance22_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Douglas, S.E. (August 2022). <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"https:\/\/www.limswiki.org\/index.php\/LIMS_FAQ:What_is_the_importance_of_a_food_and_beverage_testing_laboratory_to_society\" data-key=\"3c9744c121e1ab4703896bf1f65f406a\">\"LIMS FAQ:What is the importance of a food and beverage testing laboratory to society?\"<\/a>. <i>LIMSwiki<\/i><span class=\"printonly\">. <a rel=\"nofollow\" class=\"external free wiki-link\" href=\"https:\/\/www.limswiki.org\/index.php\/LIMS_FAQ:What_is_the_importance_of_a_food_and_beverage_testing_laboratory_to_society\" data-key=\"3c9744c121e1ab4703896bf1f65f406a\">https:\/\/www.limswiki.org\/index.php\/LIMS_FAQ:What_is_the_importance_of_a_food_and_beverage_testing_laboratory_to_society<\/a>?<\/span><span class=\"reference-accessdate\">. Retrieved 02 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=LIMS+FAQ%3AWhat+is+the+importance+of+a+food+and+beverage+testing+laboratory+to+society%3F&rft.atitle=LIMSwiki&rft.aulast=Douglas%2C+S.E.&rft.au=Douglas%2C+S.E.&rft.date=August+2022&rft_id=https%3A%2F%2Fwww.limswiki.org%2Findex.php%2FLIMS_FAQ%3AWhat_is_the_importance_of_a_food_and_beverage_testing_laboratory_to_society%3F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Pavlovi.C4.87What17-2\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-Pavlovi.C4.87What17_2-0\">2.0<\/a><\/sup> <sup><a href=\"#cite_ref-Pavlovi.C4.87What17_2-1\">2.1<\/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 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+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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PJBRCGS20-3\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-PJBRCGS20_3-0\">3.0<\/a><\/sup> <sup><a href=\"#cite_ref-PJBRCGS20_3-1\">3.1<\/a><\/sup> <sup><a href=\"#cite_ref-PJBRCGS20_3-2\">3.2<\/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). 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IFS Management GmbH<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.ifs-certification.com\/index.php\/en\/\" target=\"_blank\">https:\/\/www.ifs-certification.com\/index.php\/en\/<\/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=IFS%3A+Global+Safety+and+Quality+Standards&rft.atitle=&rft.pub=IFS+Management+GmbH&rft_id=https%3A%2F%2Fwww.ifs-certification.com%2Findex.php%2Fen%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-IFSStandards-15\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-IFSStandards_15-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/index.php\/en\/standards\" target=\"_blank\">\"IFS Standards\"<\/a>. IFS Management GmbH<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.ifs-certification.com\/index.php\/en\/standards\" target=\"_blank\">https:\/\/www.ifs-certification.com\/index.php\/en\/standards<\/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=IFS+Standards&rft.atitle=&rft.pub=IFS+Management+GmbH&rft_id=https%3A%2F%2Fwww.ifs-certification.com%2Findex.php%2Fen%2Fstandards&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ISO22000-16\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ISO22000_16-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/iso-22000-food-safety-management.html\" target=\"_blank\">\"ISO 22000 Food safety management\"<\/a>. International Organization for Standardization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.iso.org\/iso-22000-food-safety-management.html\" target=\"_blank\">https:\/\/www.iso.org\/iso-22000-food-safety-management.html<\/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=ISO+22000+Food+safety+management&rft.atitle=&rft.pub=International+Organization+for+Standardization&rft_id=https%3A%2F%2Fwww.iso.org%2Fiso-22000-food-safety-management.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ISO22000Home-17\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ISO22000Home_17-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/committee.iso.org\/home\/tc34sc17\" target=\"_blank\">\"ISO\/TC34\/SC17\"<\/a>. International Organization for Standardization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/committee.iso.org\/home\/tc34sc17\" target=\"_blank\">https:\/\/committee.iso.org\/home\/tc34sc17<\/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=ISO%2FTC34%2FSC17&rft.atitle=&rft.pub=International+Organization+for+Standardization&rft_id=https%3A%2F%2Fcommittee.iso.org%2Fhome%2Ftc34sc17&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ISO22002-1-18\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ISO22002-1_18-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">\"ISO\/TS 22002-1:2009 Prerequisite programmes on food safety \u2014 Part 1: Food manufacturing\"<\/a>. International Organization for Standardization. December 2009<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.iso.org\/standard\/44001.html\" target=\"_blank\">https:\/\/www.iso.org\/standard\/44001.html<\/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=ISO%2FTS+22002-1%3A2009+Prerequisite+programmes+on+food+safety+%E2%80%94+Part+1%3A+Food+manufacturing&rft.atitle=&rft.date=December+2009&rft.pub=International+Organization+for+Standardization&rft_id=https%3A%2F%2Fwww.iso.org%2Fstandard%2F44001.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ISO22002-4-19\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ISO22002-4_19-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">\"ISO\/TS 22002-4:2013 Prerequisite programmes on food safety \u2014 Part 4: Food packaging manufacturing\"<\/a>. International Organization for Standardization. December 2013<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.iso.org\/standard\/60969.html\" target=\"_blank\">https:\/\/www.iso.org\/standard\/60969.html<\/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=ISO%2FTS+22002-4%3A2013+Prerequisite+programmes+on+food+safety+%E2%80%94+Part+4%3A+Food+packaging+manufacturing&rft.atitle=&rft.date=December+2013&rft.pub=International+Organization+for+Standardization&rft_id=https%3A%2F%2Fwww.iso.org%2Fstandard%2F60969.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ISO22002-6-20\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ISO22002-6_20-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">\"ISO\/TS 22002-6:2016 Prerequisite programmes on food safety \u2014 Part 6: Feed and animal food production\"<\/a>. International Organization for Standardization. April 2016<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.iso.org\/standard\/66126.html\" target=\"_blank\">https:\/\/www.iso.org\/standard\/66126.html<\/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=ISO%2FTS+22002-6%3A2016+Prerequisite+programmes+on+food+safety+%E2%80%94+Part+6%3A+Feed+and+animal+food+production&rft.atitle=&rft.date=April+2016&rft.pub=International+Organization+for+Standardization&rft_id=https%3A%2F%2Fwww.iso.org%2Fstandard%2F66126.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SQFCode-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SQFCode_21-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/resource-center\/sqf-code-edition-9-downloads\/\" target=\"_blank\">\"SQF Code \u2013 Edition 9 Downloads\"<\/a>. SQF Institute. 24 May 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.sqfi.com\/resource-center\/sqf-code-edition-9-downloads\/\" target=\"_blank\">https:\/\/www.sqfi.com\/resource-center\/sqf-code-edition-9-downloads\/<\/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=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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230110191015\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.167 seconds\nReal time usage: 0.178 seconds\nPreprocessor visited node count: 14279\/1000000\nPost\u2010expand include size: 105720\/2097152 bytes\nTemplate argument size: 33429\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 35076\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 156.072 1 -total\n 90.31% 140.949 1 Template:Reflist\n 71.68% 111.878 21 Template:Citation\/core\n 67.40% 105.199 20 Template:Cite_web\n 14.17% 22.118 17 Template:Date\n 11.52% 17.978 1 Template:Cite_journal\n 9.63% 15.033 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\n 4.69% 7.318 4 Template:Citation\/identifier\n 3.90% 6.086 26 Template:Citation\/make_link\n 1.36% 2.119 8 Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13927-0!canonical and timestamp 20230110191016 and revision id 50878. 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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_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>","e3e9feec19733f9743b173dea0d9991c_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/d\/d0\/Food_Safety_Tips.jpg"],"e3e9feec19733f9743b173dea0d9991c_timestamp":1673378970,"18c2f1894d54c6a47eb76c2bace78144_type":"article","18c2f1894d54c6a47eb76c2bace78144_title":"1.3 Safety and quality in the food and beverage industry","18c2f1894d54c6a47eb76c2bace78144_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_industry","18c2f1894d54c6a47eb76c2bace78144_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Introduction to food and beverage laboratories\/Safety and quality in the food and beverage industryFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n1.3 Safety and quality in the food and beverage industry \nAccording 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.\"[1] As of December 2022, the CDC has yet to issue revised estimates of these numbers. However, one can wonder if those numbers are higher post-COVID. On a more global scale, the World Health Organization (WHO) estimates that one in ten people worldwide fall ill to consuming contaminated food.[2] These and other statistics highlight the vital nature of improving safety and quality in the world's food supplies. As the world's population continues to grow and modernize\u2014particularly in the face of the challenges that climate change brings[3][4]\u2014the demand for a stronger focus on food safety and quality will continue to grow. Without a continued focus on food and water security\u2014including all the quality and safety assurances that come with it\u2014many elements of the world population face a grim reality of insufficient food, limited access to clean water, and malnutrition.[5][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.\nWe also must look outside the government level, to presumably the bulk of food and beverage labs located in the private sector. We have to use \"presumably\" because, as Robin Stombler of Food Safety Tech noted in April 2016, no one really knows how many food laboratories exist in, for example, the U.S.[9] As Stombler noted, this causes several problems[9]:\n\nFor example, we do not have a centralized way of determining if a particular laboratory has deficiencies in testing practices or if its accreditation has been revoked. Without knowing where and by whom testing is conducted, we are at a disadvantage in developing nationwide systems for tracking foodborne disease outbreaks and notifying laboratory professionals of emerging pathogens. We most certainly do not know if all food laboratories are following recognized testing methods and standards that affect the food we all consume.\nThe FDA finally made some minor progress in this department, announcing in December 2021 that food and beverage labs conducting a specific range of activities would need to become accredited, and a list of accredited labs would be maintained.[10][11] The accreditation described under the FDA's LAAF rule is voluntary, but labs wanting to participate will need to get accredited.[10] For now, only specific types of testing require accreditation, including sprouts, mass-produced eggs, bottled drinking water, certain imports, and certain items affected by recalls and other regulatory action.[12] This may expand in the future, and it may force more food and beverage labs to become accredited and recognized.\nThat said, these third-party food safety and quality labs exist not just because of regulatory controls, but also because private incentives towards maintaining reputation and a standard of quality in the industry. Virginia Tech's John Bovay emphasized this in an August 2022 research paper[13]:\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 foods and beverages. 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.\n\nReferences \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 07 December 2022 .   \n \n\n\u2191 \"Estimating the burden of foodborne diseases\". World Health Organization. https:\/\/www.who.int\/activities\/estimating-the-burden-of-foodborne-diseases . Retrieved 07 December 2022 .   \n \n\n\u2191 Molotoks, Amy; Smith, Pete; Dawson, Terence P. (1 February 2021). \"Impacts of land use, population, and climate change on global food security\" (in en). Food and Energy Security 10 (1). doi:10.1002\/fes3.261. ISSN 2048-3694. https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/fes3.261 .   \n \n\n\u2191 Din, Muhammad Sami Ul; Mubeen, Muhammad; Hussain, Sajjad; Ahmad, Ashfaq; Hussain, Nazim; Ali, Muhammad Anjum; El Sabagh, Ayman; Elsabagh, Mabrouk et al.. (2022), Jatoi, Wajid Nasim; Mubeen, Muhammad; Ahmad, Ashfaq et al.., eds., \"World Nations Priorities on Climate Change and Food Security\" (in en), Building Climate Resilience in Agriculture (Cham: Springer International Publishing): 365\u2013384, doi:10.1007\/978-3-030-79408-8_22, ISBN 978-3-030-79407-1, https:\/\/link.springer.com\/10.1007\/978-3-030-79408-8_22 . Retrieved 2022-08-10   \n \n\n\u2191 Niza-Ribeiro, Jo\u00e3o (2022), \"Food and water security and safety for an ever-expanding human population\" (in en), One Health (Elsevier): 155\u2013204, doi:10.1016\/b978-0-12-822794-7.00003-4, ISBN 978-0-12-822794-7, https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/B9780128227947000034 . Retrieved 2022-08-10   \n \n\n\u2191 Miller, Joshua D; Workman, Cassandra L; Panchang, Sarita V; Sneegas, Gretchen; Adams, Ellis A; Young, Sera L; Thompson, Amanda L (1 December 2021). \"Water Security and Nutrition: Current Knowledge and Research Opportunities\" (in en). Advances in Nutrition 12 (6): 2525\u20132539. doi:10.1093\/advances\/nmab075. ISSN 2161-8313. PMC PMC8634318. PMID 34265039. https:\/\/academic.oup.com\/advances\/article\/12\/6\/2525\/6322255 .   \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 14 August 2022 .   \n \n\n\u2191 \"About FoodNet\". Centers for Disease Control and Prevention. 23 September 2021. https:\/\/www.cdc.gov\/foodnet\/about.html . Retrieved 07 December 2022 .   \n \n\n\u2191 9.0 9.1 Stombler, R. (4 April 2016). \"Counting Food Laboratories\". Food Safety Tech. https:\/\/foodsafetytech.com\/feature_article\/counting-food-laboratories\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 10.0 10.1 News Desk (10 December 2021). \"Laboratory accreditation required by FSMA finally becoming a reality\". Food Safety News. https:\/\/www.foodsafetynews.com\/2021\/12\/laboratory-accreditation-required-by-fsma-finally-becoming-a-reality\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 \"FDA Releases New Dashboard for Laboratory Accreditation for Analyses of Foods Program\". Food Safety Magazine. 5 August 2022. https:\/\/www.food-safety.com\/articles\/7923-fda-releases-new-dashboard-for-laboratory-accreditation-for-analyses-of-foods-program . Retrieved 07 December 2022 .   \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 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 food and beverage laboratories\nTitle: LIMS Selection Guide for Food Safety and Quality\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_industry\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_industry<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:09.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","18c2f1894d54c6a47eb76c2bace78144_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Introduction_to_food_and_beverage_laboratories_Safety_and_quality_in_the_food_and_beverage_industry rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Introduction_to_food_and_beverage_laboratories_Safety_and_quality_in_the_food_and_beverage_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 Food Safety and Quality\/Introduction to food and beverage laboratories\/Safety and quality in the food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"1.3_Safety_and_quality_in_the_food_and_beverage_industry\">1.3 Safety and quality in the food and beverage industry<\/span><\/h3>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:FDA_Food_Safety_%26_Applied_Nutrition_Lab_(3852)_(7944691158).jpg\" class=\"image wiki-link\" data-key=\"7e1ac80656b3fbd83b1fa99cb3ec00a8\"><img alt=\"FDA Food Safety & Applied Nutrition Lab (3852) (7944691158).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/7\/7d\/FDA_Food_Safety_%26_Applied_Nutrition_Lab_%283852%29_%287944691158%29.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>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_1-0\" class=\"reference\"><a href=\"#cite_note-CDCBurdenFood18-1\">[1]<\/a><\/sup> As of December 2022, the CDC has yet to issue revised estimates of these numbers. However, one can wonder if those numbers are higher post-COVID. On a more global scale, the World Health Organization (WHO) estimates that one in ten people worldwide fall ill to consuming contaminated food.<sup id=\"rdp-ebb-cite_ref-WHOBurdenFood_2-0\" class=\"reference\"><a href=\"#cite_note-WHOBurdenFood-2\">[2]<\/a><\/sup> These and other statistics highlight the vital nature of improving safety and quality in the world's food supplies. As the world's population continues to grow and modernize\u2014particularly in the face of the challenges that climate change brings<sup id=\"rdp-ebb-cite_ref-MolotoksImpacts21_3-0\" class=\"reference\"><a href=\"#cite_note-MolotoksImpacts21-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DinWorld22_4-0\" class=\"reference\"><a href=\"#cite_note-DinWorld22-4\">[4]<\/a><\/sup>\u2014the demand for a stronger focus on food safety and quality will continue to grow. Without a continued focus on food and water security\u2014including all the quality and safety assurances that come with it\u2014many elements of the world population face a grim reality of insufficient food, limited access to clean water, and malnutrition.<sup id=\"rdp-ebb-cite_ref-NizaRibieroFood22_5-0\" class=\"reference\"><a href=\"#cite_note-NizaRibieroFood22-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MillerWater21_6-0\" class=\"reference\"><a href=\"#cite_note-MillerWater21-6\">[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>We also must look outside the government level, to presumably the bulk of food and beverage labs located in the private sector. We have to use \"presumably\" because, as Robin Stombler of <i>Food Safety Tech<\/i> noted in April 2016, no one really knows how many food laboratories exist in, for example, the U.S.<sup id=\"rdp-ebb-cite_ref-StomblerCount16_9-0\" class=\"reference\"><a href=\"#cite_note-StomblerCount16-9\">[9]<\/a><\/sup> As Stombler noted, this causes several problems<sup id=\"rdp-ebb-cite_ref-StomblerCount16_9-1\" class=\"reference\"><a href=\"#cite_note-StomblerCount16-9\">[9]<\/a><\/sup>:\n<\/p>\n<blockquote><p>For example, we do not have a centralized way of determining if a particular laboratory has deficiencies in testing practices or if its accreditation has been revoked. Without knowing where and by whom testing is conducted, we are at a disadvantage in developing nationwide systems for tracking foodborne disease outbreaks and notifying laboratory professionals of emerging pathogens. We most certainly do not know if all food laboratories are following recognized testing methods and standards that affect the food we all consume.<\/p><\/blockquote>\n<p>The FDA finally made some minor progress in this department, announcing in December 2021 that food and beverage labs conducting a specific range of activities would need to become accredited, and a list of accredited labs would be maintained.<sup id=\"rdp-ebb-cite_ref-FSNLab21_10-0\" class=\"reference\"><a href=\"#cite_note-FSNLab21-10\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FSMFDARel22_11-0\" class=\"reference\"><a href=\"#cite_note-FSMFDARel22-11\">[11]<\/a><\/sup> The accreditation described under the FDA's LAAF rule is voluntary, but labs wanting to participate will need to get accredited.<sup id=\"rdp-ebb-cite_ref-FSNLab21_10-1\" class=\"reference\"><a href=\"#cite_note-FSNLab21-10\">[10]<\/a><\/sup> For now, only specific types of testing require accreditation, including sprouts, mass-produced eggs, bottled drinking water, certain imports, and certain items affected by recalls and other regulatory action.<sup id=\"rdp-ebb-cite_ref-DouglasFDA22_12-0\" class=\"reference\"><a href=\"#cite_note-DouglasFDA22-12\">[12]<\/a><\/sup> This may expand in the future, and it may force more food and beverage labs to become accredited and recognized.\n<\/p><p>That said, these third-party food safety and quality labs exist not just because of regulatory controls, but also because private incentives towards maintaining reputation and a standard of quality in the industry. Virginia Tech's John Bovay emphasized this in an August 2022 research paper<sup id=\"rdp-ebb-cite_ref-13\" class=\"reference\"><a href=\"#cite_note-13\">[13]<\/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 foods and beverages. 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.\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-CDCBurdenFood18-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCBurdenFood18_1-0\">\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 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=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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WHOBurdenFood-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WHOBurdenFood_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/activities\/estimating-the-burden-of-foodborne-diseases\" target=\"_blank\">\"Estimating the burden of foodborne diseases\"<\/a>. World Health Organization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.who.int\/activities\/estimating-the-burden-of-foodborne-diseases\" target=\"_blank\">https:\/\/www.who.int\/activities\/estimating-the-burden-of-foodborne-diseases<\/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=Estimating+the+burden+of+foodborne+diseases&rft.atitle=&rft.pub=World+Health+Organization&rft_id=https%3A%2F%2Fwww.who.int%2Factivities%2Festimating-the-burden-of-foodborne-diseases&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MolotoksImpacts21-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MolotoksImpacts21_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Molotoks, Amy; Smith, Pete; Dawson, Terence P. (1 February 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/fes3.261\" target=\"_blank\">\"Impacts of land use, population, and climate change on global food security\"<\/a> (in en). <i>Food and Energy Security<\/i> <b>10<\/b> (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\/10.1002%2Ffes3.261\" target=\"_blank\">10.1002\/fes3.261<\/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\/2048-3694\" target=\"_blank\">2048-3694<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/fes3.261\" target=\"_blank\">https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/fes3.261<\/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=Impacts+of+land+use%2C+population%2C+and+climate+change+on+global+food+security&rft.jtitle=Food+and+Energy+Security&rft.aulast=Molotoks&rft.aufirst=Amy&rft.au=Molotoks%2C%26%2332%3BAmy&rft.au=Smith%2C%26%2332%3BPete&rft.au=Dawson%2C%26%2332%3BTerence+P.&rft.date=1+February+2021&rft.volume=10&rft.issue=1&rft_id=info:doi\/10.1002%2Ffes3.261&rft.issn=2048-3694&rft_id=https%3A%2F%2Fonlinelibrary.wiley.com%2Fdoi%2F10.1002%2Ffes3.261&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DinWorld22-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DinWorld22_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation\" id=\"rdp-ebb-CITEREFDinMubeenHussainAhmad2022\">Din, Muhammad Sami Ul; Mubeen, Muhammad; Hussain, Sajjad; Ahmad, Ashfaq; Hussain, Nazim; Ali, Muhammad Anjum; El Sabagh, Ayman; Elsabagh, Mabrouk <i>et al.<\/i>. (2022), Jatoi, Wajid Nasim; Mubeen, Muhammad; Ahmad, Ashfaq <i>et al.<\/i>., eds., <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/link.springer.com\/10.1007\/978-3-030-79408-8_22\" target=\"_blank\">\"World Nations Priorities on Climate Change and Food Security\"<\/a> (in en), <i>Building Climate Resilience in Agriculture<\/i> (Cham: Springer International Publishing): 365\u2013384, <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%2F978-3-030-79408-8_22\" target=\"_blank\">10.1007\/978-3-030-79408-8_22<\/a>, <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-3-030-79407-1<span class=\"printonly\">, <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/link.springer.com\/10.1007\/978-3-030-79408-8_22\" target=\"_blank\">https:\/\/link.springer.com\/10.1007\/978-3-030-79408-8_22<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 2022-08-10<\/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=World+Nations+Priorities+on+Climate+Change+and+Food+Security&rft.jtitle=Building+Climate+Resilience+in+Agriculture&rft.aulast=Din&rft.aufirst=Muhammad+Sami+Ul&rft.au=Din%2C%26%2332%3BMuhammad+Sami+Ul&rft.au=Mubeen%2C%26%2332%3BMuhammad&rft.au=Hussain%2C%26%2332%3BSajjad&rft.au=Ahmad%2C%26%2332%3BAshfaq&rft.au=Hussain%2C%26%2332%3BNazim&rft.au=Ali%2C%26%2332%3BMuhammad+Anjum&rft.au=El+Sabagh%2C%26%2332%3BAyman&rft.au=Elsabagh%2C%26%2332%3BMabrouk&rft.au=Shah%2C%26%2332%3BGhulam+Mustafa&rft.date=2022&rft.pages=365%E2%80%93384&rft.place=Cham&rft.pub=Springer+International+Publishing&rft_id=info:doi\/10.1007%2F978-3-030-79408-8_22&rft.isbn=978-3-030-79407-1&rft_id=https%3A%2F%2Flink.springer.com%2F10.1007%2F978-3-030-79408-8_22&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NizaRibieroFood22-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NizaRibieroFood22_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation\" id=\"rdp-ebb-CITEREFNiza-Ribeiro2022\">Niza-Ribeiro, Jo\u00e3o (2022), <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/B9780128227947000034\" target=\"_blank\">\"Food and water security and safety for an ever-expanding human population\"<\/a> (in en), <i>One Health<\/i> (Elsevier): 155\u2013204, <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%2Fb978-0-12-822794-7.00003-4\" target=\"_blank\">10.1016\/b978-0-12-822794-7.00003-4<\/a>, <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-12-822794-7<span class=\"printonly\">, <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/B9780128227947000034\" target=\"_blank\">https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/B9780128227947000034<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 2022-08-10<\/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+and+water+security+and+safety+for+an+ever-expanding+human+population&rft.jtitle=One+Health&rft.aulast=Niza-Ribeiro&rft.aufirst=Jo%C3%A3o&rft.au=Niza-Ribeiro%2C%26%2332%3BJo%C3%A3o&rft.date=2022&rft.pages=155%E2%80%93204&rft.pub=Elsevier&rft_id=info:doi\/10.1016%2Fb978-0-12-822794-7.00003-4&rft.isbn=978-0-12-822794-7&rft_id=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FB9780128227947000034&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MillerWater21-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MillerWater21_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Miller, Joshua D; Workman, Cassandra L; Panchang, Sarita V; Sneegas, Gretchen; Adams, Ellis A; Young, Sera L; Thompson, Amanda L (1 December 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/academic.oup.com\/advances\/article\/12\/6\/2525\/6322255\" target=\"_blank\">\"Water Security and Nutrition: Current Knowledge and Research Opportunities\"<\/a> (in en). <i>Advances in Nutrition<\/i> <b>12<\/b> (6): 2525\u20132539. <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%2Fadvances%2Fnmab075\" target=\"_blank\">10.1093\/advances\/nmab075<\/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\/2161-8313\" target=\"_blank\">2161-8313<\/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\/PMC8634318\/\" target=\"_blank\">PMC8634318<\/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\/34265039\" target=\"_blank\">34265039<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/academic.oup.com\/advances\/article\/12\/6\/2525\/6322255\" target=\"_blank\">https:\/\/academic.oup.com\/advances\/article\/12\/6\/2525\/6322255<\/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=Water+Security+and+Nutrition%3A+Current+Knowledge+and+Research+Opportunities&rft.jtitle=Advances+in+Nutrition&rft.aulast=Miller&rft.aufirst=Joshua+D&rft.au=Miller%2C%26%2332%3BJoshua+D&rft.au=Workman%2C%26%2332%3BCassandra+L&rft.au=Panchang%2C%26%2332%3BSarita+V&rft.au=Sneegas%2C%26%2332%3BGretchen&rft.au=Adams%2C%26%2332%3BEllis+A&rft.au=Young%2C%26%2332%3BSera+L&rft.au=Thompson%2C%26%2332%3BAmanda+L&rft.date=1+December+2021&rft.volume=12&rft.issue=6&rft.pages=2525%E2%80%932539&rft_id=info:doi\/10.1093%2Fadvances%2Fnmab075&rft.issn=2161-8313&rft_id=info:pmc\/PMC8634318&rft_id=info:pmid\/34265039&rft_id=https%3A%2F%2Facademic.oup.com%2Fadvances%2Farticle%2F12%2F6%2F2525%2F6322255&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_industry\"><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. 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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+Releases+New+Dashboard+for+Laboratory+Accreditation+for+Analyses+of+Foods+Program&rft.atitle=Food+Safety+Magazine&rft.date=5+August+2022&rft_id=https%3A%2F%2Fwww.food-safety.com%2Farticles%2F7923-fda-releases-new-dashboard-for-laboratory-accreditation-for-analyses-of-foods-program&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DouglasFDA22-12\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DouglasFDA22_12-0\">\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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_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 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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_industry\"><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_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Standards and regulations affecting food and beverage labs\/Globally recognized food safety standards\" class=\"wiki-link\" data-key=\"e3e9feec19733f9743b173dea0d9991c\">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>: 1. Introduction to food and beverage laboratories\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for Food Safety and Quality<\/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>: January 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230110191045\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.135 seconds\nReal time usage: 0.143 seconds\nPreprocessor visited node count: 10677\/1000000\nPost\u2010expand include size: 98201\/2097152 bytes\nTemplate argument size: 29987\/2097152 bytes\nHighest expansion depth: 25\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 27044\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 126.380 1 -total\n 93.09% 117.643 1 Template:Reflist\n 70.26% 88.793 13 Template:Citation\/core\n 42.48% 53.684 8 Template:Cite_web\n 25.09% 31.706 3 Template:Cite_journal\n 13.85% 17.509 2 Template:Citation\n 13.35% 16.875 12 Template:Date\n 8.08% 10.217 12 Template:Citation\/identifier\n 6.86% 8.665 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_industry\n 3.87% 4.896 18 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13926-0!canonical and timestamp 20230110191045 and revision id 50877. 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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_industry\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_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>","18c2f1894d54c6a47eb76c2bace78144_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/7\/7d\/FDA_Food_Safety_%26_Applied_Nutrition_Lab_%283852%29_%287944691158%29.jpg"],"18c2f1894d54c6a47eb76c2bace78144_timestamp":1673378970,"4922bb8abd32879cd573c6f2886e1456_type":"article","4922bb8abd32879cd573c6f2886e1456_title":"1.2 Laboratory roles and testing in the industry","4922bb8abd32879cd573c6f2886e1456_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry","4922bb8abd32879cd573c6f2886e1456_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Introduction to food and beverage laboratories\/Laboratory roles and testing in the industryFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 1.2 Laboratory roles and testing in the industry \n\n1.1 1.2.1 R&D roles and testing \n1.2 1.2.2 Pre-manufacturing and manufacturing roles and testing \n1.3 1.2.3 Post-production regulation and security roles and testing \n1.4 1.2.4 Tangential laboratory work \n\n\n2 References \n\n\n\n1.2 Laboratory roles and testing in the industry \nLaboratories directly and tangentially related to the food and beverage industry play a number of roles, depending on where they're situated. 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 testing.\nFood and beverage laboratories tap into numerous scientific disciplines for the work they do. Among the various roles these labs serve, disciplines such as biochemistry, biotechnology, chemical engineering, chemistry, fermentation science, materials science, microbiology, molecular gastronomy, and nutrition and food science are applied.[1][2][3][4] As such, a diverse skillset is typically required by the food and beverage scientist, requiring not only hard skills in microbiology, biochemistry, and fermentation, but also the flexibility and nimbleness to apply those skills to an industry with a rapidly changing consumer dynamic.[5] \nAlthough slightly dated, past surveys of food processors have largely shown a majority of testing occurring within the processor facility, with outsourcing to a third-party lab becoming a growing trend. A 2013 Advantage Business Media survey of food processors \"found 32.5 percent use both in-house and outside labs; 28.9 percent use only in-house testing, and 24.1 percent send samples only to outside labs,\" with 14.5 percent saying they didn\u2019t require testing.[6] A 2017 survey by Strategic Consulting, Inc., published in Food Safety Magazine, saw the number of labs sending samples only to outside labs increase, compared to the 2013 survey, with 28% of respondents saying they outsourced all samples.[7] Similar surveys in 2020 reinforced the view that outsourcing was a growing trend, with more non-pathogen testing getting outsourced along with pathogen testing.[8][9]\nThis increase may not be surprising given reports that third-party contract testing laboratories were increasingly being used for food quality and safety testing. A 2013 Strategic Consulting, Inc. report cited the rise in third-party labs was \"in response to the growing complexity, cost, and volume of testing required by food producers and retailers.\"[10] Another concern that may be driving outsourcing of at least microbial laboratory testing is regulatory pressure concerning pathogenic organisms in the production facility, and by extension out of the internally housed lab, though there may be a strong preference to contract with third-party labs in close proximity to the plant to better ensure desired turnaround times.[7] However, veterans in the food and beverage industry may view such outsourcing concerns as minimal, particularly when a facility's processes and quality mechanisms are appropriately reviewed, maintained, and enforced.[7]\nIn regards to what kind of testing has historically been occurring in the industry, we turn back to that 2013 Advantage Business Media survey. Additional statistics from that survey revealed that 70.6 percent of respondents were testing for quality, 57.7 percent were testing for consistency, and 56.5 percent were conducting food safety tests for pathogens. Some 29.4 percent were testing for packaging accuracy claims, and 23.5 percent were testing for the presence of reported and unreported allergens.[6] More recent survey data is difficult to find, so it's not clear how these numbers compare to the realities of 2022. We can say that at least as of 2020, pathogen testing remained vital, with testing of Listeria proving a fast-growing subcategory of pathogen testing, primarily for environmental monitoring of the production facility.[8][9] A 2020 survey by Strategic Consulting, Inc. further indicated that the volume of microbiology testing is growing at roughly five percent, while pathogen testing volume is growing at roughly six to seven percent, adding that \"outsourcing is driving the volume of tests being sent to commercial labs by as much as 10 percent.\"[9] The same surveyor increased those percentages the following year.[11] \nFinally, Strategic Consulting's Bob Ferguson added that polymerase chain reaction (PCR) is seeing an uptick in food and beverage testing as of 2021[12]:\n\nAs processors outsource their samples, PCR seems to be more frequently selected as the analytical method used than it was when the samples were analyzed in-plant. This possibility certainly makes sense. PCR requires expensive instrumentation and technical expertise to analyze samples properly. Every commercial lab will have a level of analyst capabilities and infrastructure that allows them to use PCR. Commercial labs will also have a high incentive to recommend the use of PCR to optimize the throughput of their instruments.\nSo far, we've spoken broadly of the food and beverage laboratory, the roles it can play in the industry, and the testing found in it. The following subsections more closely examine the three roles labs can play, as well as the testing found within those roles.\n\n 1.2.1 R&D roles and testing \nThe laboratory participating in this role is performing one or more tasks that relate to the development or improvement of a food, beverage, additive, or spice. This often leads to a commercial formulation, which has the \"necessary details required to scale and produce your [food or beverage] in a consistent, efficient, and safe manner.\"[13] Even packaging solutions are targets for R&D labs in the food and beverage industry.[14]\nThe 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.[15] Other companies may take their R&D to a third-party lab dedicated to conducting development and formulation activities for manufacturers.[13][14] Food and beverage research activities aren't confined to manufacturers, however. Some higher education institutions, such as the Hartwick College Center for Craft Food & Beverage, provide laboratory-based research and development opportunities to students engaging in work-study programs, often in partnership with some other commercial enterprise.[16] \nFood and beverage R&D labs may work towards improving packaging, testing a product's shelf life (i.e., stability), conducting flavor or aroma analysis, developing and innovating foodstuffs, reformulating existing products, and researching genetic modifications to ingredients. The end user benefits by having fresher foods that are culinarily pleasing, more nutritious, and safer for consumption.\nThe following types of testing may be associated with the R&D role:\nOverall food innovation and development: International Center for Food Chain and Network Research's Schiefer and Deiters note that the food and beverage industry as a whole faces a number of significant challenges today, including economic and noneconomic changes, consumer lifestyle changes, global increases in food consumption, degradation and loss of cropland, and societal changes to attitudes concerning sustainability.[17] These types of challenges require a food and beverage industry that is more agile and innovative, one that is making impactful breakthroughs to improve the quality and range of products, increasing the capacity for making products, replacing outdated products, developing more flexible or sustainable processes, and improving health and safety.[18] Given the broad scope of efforts involved, the laboratory services for such impactful R&D efforts can vary widely depending on the goal. Improving the flavor of plant-based meat substitutes, for example, comes with somewhat different analytical techniques and disciplinary requirements than say improving the three-dimensional food printing of said meat substitutes.[19]\nAroma\/flavor analysis and formulation: Here the concept of \"sensomic\" study, an approach to describing the sensory properties of foodstuffs at a molecular level[20], plays an increasingly important role.[20][21] This involves analytical techniques such as gas chromatography, liquid chromatography, and spectrophotometry, used in conjunction with chemometric data analysis to isolate and act upon volatile compounds from one or more samples.[20][21][22] Aroma tends to be a more difficult concept to tackle as we've identified more than a 1,000 volatile compounds in a singular substance such as cooked meats and coffees (though typically only a small number of those compounds make a significant contribution to the overall perceived aroma[22]), which in turn adds further complexity to overall perception of flavor.[21] This gives laboratory researchers formulating a product for a distinct flavor profile more than a few challenges in, for example, putting together a successful mapping of chemical composition to flavor perception.[23]\nGenetic modification for improved yields and nutrition: The preface of Westin Carrillo's book Biotechnology and Food Production summarizes this activity well. \"Biotechnology can be used in many ways to achieve higher yields; for example, by improving flowering capacity and increasing photosynthesis or the intake of nutritive elements,\" he says. \"In the long term, genetic engineering will also help to increase production of the most valuable components of specific crops\" like cassava and rice, as well as modify their amino acid composition in order to increase their otherwise deficient nutritional value.[24] As this suggests, however, knowledge and skills in genetic analysis, modification, and expression are required, in turn requiring the equipment and skill for genetic sequencing, microbial transformation, genetic use restriction technology (GURT), Northern or Western blotting, reverse transcription polymerase chain reaction (RT-PCR), etc.[24] Admittedly, this type of R&D may fall more firmly in the hands of agriculture businesses than food and beverage businesses themselves. However, a few food and beverage business may bring their genetic modification R&D efforts in-house as an overall effort to improve a majority of its products.\nNutritional reformulation: As various scientific understandings improve and societies shift their desires and perspectives towards processed foods, so too do the formulations used by food processors. Food scientist and author Maurice O'Sullivan describes four primary drivers for these types of reformulations[25]:\n\nSociety improves its scientific understanding of the major consumption-related diseases affecting human civilization, including coronary heart disease, diabetes, hypertension, and obesity.\nThe population at large becomes more aware of scientists' greater understanding of consumption-related diseases.\nFood producers inevitably see reason to make changes to their foods based on both the scientific and customer-based factors that affect sales of the producers' products.\nGovernment further provides incentive to the producer to modify their product, through industry collaboration or outright regulation and enforcement activities.\nO'Sullivan argues that the three most significant components of food that need to be modified are salt, fat, and sugar. Balancing these in reformulations is indeed challenging for chemical, sensory, and other reasons.[25] Adjusting salt levels, for example, requires chemical knowledge about salt reduction's effects on meat's shelf life and what substitutes or additives can be used to balance out the reduced salt content.[26] As such, reformulation requires a broad array of analytical techniques and industry knowledge, varying based upon the component sought out for change.\nStability, cycle, and challenge testing: As hinted at in the prior subsection, salt plays an important role in the shelf life of meats and other foodstuffs.[26] However, it also can be a leading contributor to cardiovascular complications.[25] Finding a balance between a more nutritious product and a more shelf-stable product proves to be quite tricky. This is one of several conundrums the stability testing laboratory faces in the food and beverage industry. Multiple deteriorative catalysts can influence the shelf life of a product, from microbiological contaminants and chemical deterioration to storage conditions and the packaging itself. As such, there are multiple approaches to those catalysts, from introducing additives to improving the packaging.[27] 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.[27] 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.[28] Calorimetry, spectrophotometry, spectroscopy, and hyperspectral imaging can be used to properly assess color, which has been shown to be a good gauge of food quality.[27] Other test types that may be used include water content, texture, viscosity, dispersibility, glass transition, and gas chromatography.[27]\nPackaging analysis and extractable and leachable testing: Materials that contact food and beverages 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.[29] As such, attempting to break new ground in food and beverage packaging development can be a tricky matter. Concerns of chemicals and elements that can be extracted or leach into food contact materials add another layer of complexity to developing and choosing packaging materials for foods and beverages. This requires extractable and leachable testing at various phases of product development to ensure the packaging selected during formulation is safe and effective.[30] 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.[31]\n\n1.2.2 Pre-manufacturing and manufacturing roles and testing \nThe laboratory participating in these roles is performing one or more tasks that relate to the preparative (i.e., pre-manufacturing) or quality control (i.e., manufacturing) tasks of food and beverage production. Preparative work such as caloric and nutritional analysis may happen in a variety of contexts, from inside the R&D lab to in the manufacturing facility's lab itself, if it has one. This work may also be conducted by a third-party lab, or it may even be performed using non-laboratory techniques such as food composition database analysis.[32][33] However, caloric and nutritional testing\u2014in conjunction with meeting regulatory-driven labeling requirements\u2014still lands firmly in the role of pre-manufacturing activity, definitively after commercial formulation and packing requirements have been finalized but before the formal manufacturing process has begun.[34] 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).[35] The end user benefits from these caloric, nutritional, and allergen analysis activities not only through the provision of a more transparent window into what they are consuming; these laboratory activities also can better ensure end users' attempts at maintaining their own good health. \nFinally, laboratory testing can also be found along the production chain in the manufacturing facility itself. This type of testing is couched as quality control testing, primarily, or as quality assurance, secondarily. Some of this analysis may be integrated into the production workflow, as with x-ray inspection.[36] Fluorescence sensing technologies are also useful for contaminant testing, though they are largely limited to laboratory use, with hopes they may become more relevant for inspection at the point of production.[37] This move to \"novel, rapid, and non-destructive\" methods of testing both in the lab and in the production facility appears to be a growing trend[38], loosening the concept of the \"quality control laboratory\" as an entity in the production facility. Regardless of analytical location, the quality control lab provides benefits to society by being a critical component of an overall quality management system that better ensures the safety of those consuming the final product.\nThe following types of testing may be associated with the pre-manufacturing and manufacturing role:\nAllergen, calorie, and nutrition testing: From label accuracy to consumer safety, this type of testing is critical to food and beverage manufacturers. Caloric and nutritional testing\u2014in conjunction with 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.[34] 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).[35] This role will usually require laboratory analytical techniques such as calorimetry, laser scanning confocal microscopy, immunoassays, and mass spectrometry.[39] Note, however, that non-laboratory techniques such as food composition database analysis are also used to evaluate the nutritional content of products that aren't heavily processed.[32][33]\nQuality control testing: A food or beverage product's launch success hinges on many variables; if one variable is off, it may very well be rejected by the consumer. Producers invest significantly in a product they believe in, requiring assurances along the way that it will have its best chance of success. The producer will want to ensure high-quality raw ingredients, high-quality equipment, an effective processing layout, and high customer satisfaction. A well-implemented quality management system (QMS) plays a major role in ensuring those requirements, and by extension that includes a type of testing couched as quality control testing, primarily, or as quality assurance testing, secondarily.[40] Many aspects of food and beverage production require high levels of quality, and as such, the type of analytical testing that takes place will vary, sometimes significantly, depending upon the associated risk. Are microbiological, physiological, or chemical risks being managed? These and other questions will determine the laboratory approach to quality, which is in turn ideally reflected in the QMS.\n\n1.2.3 Post-production regulation and security roles and testing \nThe laboratory participating in these roles is performing one or more tasks that relate to the post-production examination of foods and beverages for regulatory, security, or accreditation purposes. This type of testing examines raw ingredients, consumable products, and packaging found not only in a production facility but also in locations such as shipping docks, farms, grocery stores, and more. 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 the source of a foodborne illness. In the last case, the lab may not even be a traditional \"food and beverage\" lab but rather a public health laboratory, highlighting in full the human safety elements associated with our food and water supplies. The human safety element is also seen in government labs such as the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service's (FSIS) Field Service Laboratories, which \"coordinate and conduct laboratory analytical services in support of the Agency's farm-to-table strategies in the disciplines of chemistry, microbiology, and pathology for food safety in meat, poultry, and egg products.\"[41] In addition to ensuring a safer food supply, society also benefits from these and similar labs by better holding producers legally accountable for their production methods and obligations.\nThe following types of testing may be associated with the post-production regulation and security role:\nAuthenticity and adulteration testing: A variety of local, regional, national, and international entities (e.g., Operation OPSON, E.U. Food Fraud Network, and U.S. Customs and Border Protection) are responsible for detecting and preventing violations of food supply chain laws and regulations across national and international borders, while also collecting evidence for investigation and prosecution. \"To support these regulatory and commercial initiatives,\" says Gerard Downey of the Teagasc Food Research Centre, \"research scientists have devoted considerable resources to the development 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.[42]\nAccreditation-led testing: At the end of 2021, the FDA amended the FSMA to include the LAAF rule, which mandates laboratory \"testing of food in certain circumstances\" be performed by LAAF-accredited laboratories. This accreditation is optional and designed for those accreditation bodies and laboratories that have been or are seeking to be be recognized by the FDA as able to LAAF-accredit or be LAAF-accredited for the testing needs of the program. LAAF's \"certain circumstances\" include not only regulatory-based testing of specific sprouts, eggs, and water, but also certain foods being considered for import into the country.[43] LAAF represents one of several legal and regulatory forces driving accreditation of food and beverage laboratories to a higher standard. It also means greater potential for more testing opportunities for the third-party food and beverage lab wishing to expand into enforcement and security roles. The type of testing they conduct will already mirror those of other roles mentioned prior, but with greater emphasis on meeting stricter testing requirements.\n\n1.2.4 Tangential laboratory work \nThe following tangential laboratory roles aren't necessarily found directly in the food and beverage facility. However, some level of laboratory work is required in these roles, which intersect with the food and beverage 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.[44] \"Improper sanitation of equipment can potentially introduce hazardous contamination to food and enhance pathogen harborage in the food-processing environment.\"[44] 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.[44] These SSOPs are not only driven by good manufacturing practice (GMP) but also appropriate and effective laboratory testing. That foundation of laboratory testing has occurred historically with the experience of food and beverage producers and those engineering and standardizing hygienic solutions for the industry. 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 \"fundamental hygienic requirements for product contact surfaces and food equipment,\" ranging from 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.[45][46] In turn, these properties require laboratory and engineering knowledge about metals, alloys, plastics, and many other materials.[46] 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.\nPublic health and clinical diagnostics for foodborne illness: While public health and clinical diagnostic laboratories are indeed of a different ilk, they are undoubtedly intertwined with the food and beverage industry. With millions of people getting sick and thousands hospitalized and dying from foodborne diseases each year in the U.S. alone[47], this fact becomes clearer. When the food and beverage industry's SSOP- and QMS-related activities go awry\u2014knowingly or unknowingly\u2014or if the consumer does not follow proper precautions with the foods and beverages they consume, public health and clinical laboratories may get involved in tracking the source of the pathogen or treating the foodborne illness, respectively. As previous discussion has noted[48], the interest of public health is at the foundation of the historical and regulatory development of the modern food and beverage industry. In the U.S., the presence of these labs is characterized by efforts such as FoodNet, a CDC program that 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.[49] As a public health tool, FoodNet helps track rates of illness from foodborne pathogens. Through its Diagnostic Laboratory Practices Tool, the public health tool extends into the clinical diagnostics realm, recruiting nearly 700 of those labs to report on their testing practices in regards to select enteric pathogens. From there, one can glean the test methods and specimen submissions being conducted.[50]\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 07 December 2022 .   \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 \"Diverse skill sets needed for growing opportunities\". Institute of Food Technologists. 26 October 2020. https:\/\/www.ift.org\/news-and-publications\/news\/2020\/october\/26\/diverse-skill-sets-needed-for-growing-opportunities . Retrieved 07 December 2022 .   \n \n\n\u2191 6.0 6.1 Flynn, D. (7 October 2013). \"Food Labs Integral to Changing World of Food Safety\". Food Safety News. https:\/\/www.foodsafetynews.com\/2013\/10\/food-labs-integral-to-changing-world-of-food-safety\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 7.0 7.1 7.2 Ferguson, B. (12 December 2017). \"Outsourcing: Pathogen Testing under the Microscope\". Food Safety Magazine. https:\/\/www.food-safety.com\/articles\/5584-outsourcing-pathogen-testing-under-the-microscope . Retrieved 07 December 2022 .   \n \n\n\u2191 8.0 8.1 Ferguson, B. (24 June 2020). \"Trends in Food Safety Testing\". Food Safety Magazine. https:\/\/www.food-safety.com\/articles\/6666-trends-in-food-safety-testing . Retrieved 07 December 2022 .   \n \n\n\u2191 9.0 9.1 9.2 Ferguson, B. (16 April 2020). \"Analytical Testing in Food Safety Continues to Grow\". Food Safety Magazine. https:\/\/www.food-safety.com\/articles\/6542-analytical-testing-in-food-safety-continues-to-grow . Retrieved 07 December 2022 .   \n \n\n\u2191 \"Third-Party Testing For Food Safety Is On The Rise\". Food Logistics. 20 December 2013. https:\/\/www.foodlogistics.com\/safety\/news\/11284235\/thirdparty-testing-for-food-safety-is-on-the-rise . Retrieved 07 December 2022 .   \n \n\n\u2191 Ferguson, B. (16 April 2021). \"Food Safety Testing to Continue to Increase in 2021\". Strategic Consulting Blog. Strategic Consulting, Inc. https:\/\/www.strategic-consult.com\/2021\/04\/food-safety-testing-to-continue-to-increase-in-2021\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 Ferguson, B. (20 June 2021). \"Food Safety Testing to Continue to Increase in 2021 (Part Two)\". Strategic Consulting Blog. Strategic Consulting, Inc. https:\/\/www.strategic-consult.com\/2021\/06\/food-safety-testing-to-continue-to-increase-in-2021-part-two\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 13.0 13.1 \"Why You Need A Commercial Formula\". BevSource. 13 August 2022. https:\/\/www.bevsource.com\/news\/why-you-need-commercial-formula .   \n \n\n\u2191 14.0 14.1 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 \"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 07 December 2022 .   \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 07 December 2022 .   \n \n\n\u2191 Schiefer, G.; Deiters, J. (2021). \"Chapter 1: Food innovation dynamics and network support\". In Galanakis, Charis Michael (in en). Innovation Strategies in the Food Industry: Tools for Implementation. Academic Press. pp. 3\u201316. ISBN 978-0-323-91552-6. https:\/\/books.google.com\/books?id=jqZJEAAAQBAJ .   \n \n\n\u2191 Bigliardi, B.; Filippelli, S. (2021). \"Chapter 2: Open innovation and incorporation between academia and the food industry\". In Galanakis, Charis Michael (in en). Innovation Strategies in the Food Industry: Tools for Implementation. Academic Press. pp. 17\u201338. ISBN 978-0-323-91552-6. https:\/\/books.google.com\/books?id=jqZJEAAAQBAJ .   \n \n\n\u2191 Patel, P. (18 February 2021). \"Beyond Burgers: Animal and Plant Cells Combined for 3D-Printed Steaks\". IEEE Spectrum. https:\/\/spectrum.ieee.org\/3d-printed-meat . Retrieved 07 December 2022 .   \n \n\n\u2191 20.0 20.1 20.2 Vrzal, Tom\u00e1\u0161; Ol\u0161ovsk\u00e1, Jana (15 October 2019). \"Sensomics - basic principles and practice\". KVASNY PRUMYSL 65 (5). doi:10.18832\/kp2019.65.166. ISSN 2570-8619. http:\/\/www.kvasnyprumysl.eu\/index.php\/kp\/article\/view\/190 .   \n \n\n\u2191 21.0 21.1 21.2 Parker, J.K.; Elmore, J.S.; Methven, L., ed. (2014). Flavour development, analysis and perception in food and beverages. Woodhead Publishing Series in Food Science, Technology and Nutrition. Waltham, MA: Woodhead Pub. pp. 448. ISBN 978-1-78242-103-0. https:\/\/books.google.com\/books?id=DnB7AwAAQBAJ&printsec=frontcover .   \n \n\n\u2191 22.0 22.1 Zellner, B.d'A.; Dugo, P.; Dugo, G. et al. (2015). \"Chapter 4: Flavor\". In Nollet, L.M.L.; Toldr\u00e1, F.. Handbook of Food Analysis (Two Volume Set) (3rd ed.). CRC Press. pp. 47\u201364. ISBN 9781482297843. https:\/\/books.google.com\/books?id=KtAdCgAAQBAJ&printsec=frontcover .   \n \n\n\u2191 Regueiro, Jorge; Negreira, Noelia; Simal-G\u00e1ndara, Jes\u00fas (3 July 2017). \"Challenges in relating concentrations of aromas and tastes with flavor features of foods\" (in en). Critical Reviews in Food Science and Nutrition 57 (10): 2112\u20132127. doi:10.1080\/10408398.2015.1048775. ISSN 1040-8398. https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/10408398.2015.1048775 .   \n \n\n\u2191 24.0 24.1 Carrillo, W. (2020). Biotechnology and Food Production. ED-Tech Press. pp. 404. ISBN 9781839473432. https:\/\/books.google.com\/books?id=qePEDwAAQBAJ&printsec=frontcover .   \n \n\n\u2191 25.0 25.1 25.2 O'Sullivan, Maurice G. (2020). \"Chapter 1: Understanding the requirement to reformulate: Science, health, consumer demand, regulation, and capability\". Salt, fat, and sugar reduction: sensory approaches for nutritional reformulation of foods and beverages. Duxford, United Kingdom: Elsevier, Woodhead Publishing. pp. 1\u201328. ISBN 978-0-12-819741-7. https:\/\/books.google.com\/books?id=vE_VDwAAQBAJ&printsec=frontcover .   \n \n\n\u2191 26.0 26.1 Kloss, Loreen; Meyer, Julia Dawn; Graeve, Lutz; Vetter, Walter (1 June 2015). \"Sodium intake and its reduction by food reformulation in the European Union \u2014 A review\" (in en). NFS Journal 1: 9\u201319. doi:10.1016\/j.nfs.2015.03.001. https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2352364615000024 .   \n \n\n\u2191 27.0 27.1 27.2 27.3 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 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 07 December 2022 .   \n \n\n\u2191 32.0 32.1 \"How to Obtain a Nutritional Analysis of Your Food Product\" (PDF). ESHA Research. December 2014. https:\/\/esha.com\/wp-content\/uploads\/2014\/12\/ESHA-Obtaining-Nutritional-Analysis-eBook.pdf . Retrieved 07 December 2022 .   \n \n\n\u2191 33.0 33.1 Noh, M.F.M.; Gunasegavan, R.D.-N.; Khalid, N.M. et al. (2020). \"Recent Techniques in Nutrient Analysis for Food Composition Database\". Molecules 25 (19): 4567. doi:10.3390\/molecules25194567. PMC PMC7582643. PMID 33036314. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7582643 .   \n \n\n\u2191 34.0 34.1 \"What Do I Need To Know About Nutrition Testing for My Beverage Brand?\". BevSource. 2 December 2022. https:\/\/www.bevsource.com\/news\/what-do-i-need-know-about-nutrition-testing-my-beverage-brand .   \n \n\n\u2191 35.0 35.1 \"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 07 December 2022 .   \n \n\n\u2191 Draus, C. (15 November 2017). \"Quality Control or Quality Assurance in the Food Industry?: X-ray Inspection Equipment Ensures Both\". Eagle PI. https:\/\/www.eaglepi.com\/blog\/quality-control-or-quality-assurance-in-the-food-industry\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 Han, A.; Hao, S.; Yang, Y. et al. (2020). \"Perspective on recent developments of nanomaterial based fluorescent sensors: applications in safety and quality control of food and beverages\". Journal of Food and Drug Analysis 28 (4): 2. doi:10.38212\/2224-6614.1270.   \n \n\n\u2191 Aadil, R.M.; Madni, G.M.; Roobab, U. et al.. \"Chapter 1. Quality Control in Beverage Production: An Overview\". In Grumezescu, A.M.; Holban, A.M.. Quality Control in the Beverage Industry. The Science of Beverages. 17. Elsevier. pp. 1-38. ISBN 9780128166826.   \n \n\n\u2191 Dimitrova, M. (8 October 2019). \"Nutrition Analysis Techniques to Determine the Nutritional Content of Food\". AZO Materials. https:\/\/www.azom.com\/article.aspx?ArticleID=18555 . Retrieved 07 December 2022 .   \n \n\n\u2191 Aadil, R.M.; Madni, G.M.; Roobab, U. et al. (2019). \"Chapter 1: Quality Control in Beverage Production: An Overview\". In Grumezescu, A.; Grumezescu, A.M.; Holban, A.M. (in English). Quality Control in the Beverage Industry. 17. Academic Press. ISBN 978-0-12-816682-6. OCLC 1122792300. https:\/\/books.google.com\/books?id=2YmpDwAAQBAJ&printsec=frontcover .   \n \n\n\u2191 \"FSIS Laboratories\". Food Safety and Inspection Service, U.S. Department of Agriculture. 26 April 2019. https:\/\/www.fsis.usda.gov\/science-data\/laboratories-procedures\/fsis-laboratories . Retrieved 07 December 2022 .   \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 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 44.0 44.1 44.2 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 46.0 46.1 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 \"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 07 December 2022 .   \n \n\n\u2191 Douglas, S.E. (16 August 2022). \"What is the importance of a food and beverage testing laboratory to society?\". LIMSwiki. https:\/\/www.limswiki.org\/index.php\/LIMS_FAQ:What_is_the_importance_of_a_food_and_beverage_testing_laboratory_to_society%3F . Retrieved 07 December 2022 .   \n \n\n\u2191 \"About FoodNet\". Centers for Disease Control and Prevention. 23 September 2021. https:\/\/www.cdc.gov\/foodnet\/about.html . Retrieved 07 December 2022 .   \n \n\n\u2191 \"Diagnostic Laboratory Practices\". FoodNet Fast. Centers for Disease Control and Prevention. 23 September 2021. https:\/\/wwwn.cdc.gov\/FoodNetFast\/LabSurvey . 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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:07.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","4922bb8abd32879cd573c6f2886e1456_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Introduction_to_food_and_beverage_laboratories_Laboratory_roles_and_testing_in_the_industry rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Introduction_to_food_and_beverage_laboratories_Laboratory_roles_and_testing_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 Food Safety and Quality\/Introduction to food and beverage laboratories\/Laboratory roles and testing 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h3><span class=\"mw-headline\" id=\"1.2_Laboratory_roles_and_testing_in_the_industry\">1.2 Laboratory roles and testing in the industry<\/span><\/h3>\n<p>Laboratories directly and tangentially related to the food and beverage industry play a number of roles, depending on where they're situated. 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 testing.\n<\/p><p>Food and beverage laboratories tap into numerous scientific disciplines for the work they do. Among the various roles these labs serve, 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 and food science are applied.<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> As such, a diverse skillset is typically required by the food and beverage scientist, requiring not only hard skills in microbiology, biochemistry, and fermentation, but also the flexibility and nimbleness to apply those skills to an industry with a rapidly changing consumer dynamic.<sup id=\"rdp-ebb-cite_ref-IFTDiverse20_5-0\" class=\"reference\"><a href=\"#cite_note-IFTDiverse20-5\">[5]<\/a><\/sup> \n<\/p><p>Although slightly dated, past surveys of food processors have largely shown a majority of testing occurring within the processor facility, with outsourcing to a third-party lab becoming a growing trend. A 2013 Advantage Business Media survey of food processors \"found 32.5 percent use both in-house and outside labs; 28.9 percent use only in-house testing, and 24.1 percent send samples only to outside labs,\" with 14.5 percent saying they didn\u2019t require testing.<sup id=\"rdp-ebb-cite_ref-FLynnFood13_6-0\" class=\"reference\"><a href=\"#cite_note-FLynnFood13-6\">[6]<\/a><\/sup> A 2017 survey by Strategic Consulting, Inc., published in <i>Food Safety Magazine<\/i>, saw the number of labs sending samples only to outside labs increase, compared to the 2013 survey, with 28% of respondents saying they outsourced all samples.<sup id=\"rdp-ebb-cite_ref-FergusonOutsou17_7-0\" class=\"reference\"><a href=\"#cite_note-FergusonOutsou17-7\">[7]<\/a><\/sup> Similar surveys in 2020 reinforced the view that outsourcing was a growing trend, with more non-pathogen testing getting outsourced along with pathogen testing.<sup id=\"rdp-ebb-cite_ref-FergusonTrends20_8-0\" class=\"reference\"><a href=\"#cite_note-FergusonTrends20-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FergusonAnal20_9-0\" class=\"reference\"><a href=\"#cite_note-FergusonAnal20-9\">[9]<\/a><\/sup>\n<\/p><p>This increase may not be surprising given reports that third-party contract testing laboratories were increasingly being used for food quality and safety testing. A 2013 Strategic Consulting, Inc. report cited the rise in third-party labs was \"in response to the growing complexity, cost, and volume of testing required by food producers and retailers.\"<sup id=\"rdp-ebb-cite_ref-FLThird13_10-0\" class=\"reference\"><a href=\"#cite_note-FLThird13-10\">[10]<\/a><\/sup> Another concern that may be driving outsourcing of at least microbial laboratory testing is regulatory pressure concerning pathogenic organisms in the production facility, and by extension out of the internally housed lab, though there may be a strong preference to contract with third-party labs in close proximity to the plant to better ensure desired turnaround times.<sup id=\"rdp-ebb-cite_ref-FergusonOutsou17_7-1\" class=\"reference\"><a href=\"#cite_note-FergusonOutsou17-7\">[7]<\/a><\/sup> However, veterans in the food and beverage industry may view such outsourcing concerns as minimal, particularly when a facility's processes and quality mechanisms are appropriately reviewed, maintained, and enforced.<sup id=\"rdp-ebb-cite_ref-FergusonOutsou17_7-2\" class=\"reference\"><a href=\"#cite_note-FergusonOutsou17-7\">[7]<\/a><\/sup>\n<\/p><p>In regards to what kind of testing has historically been occurring in the industry, we turn back to that 2013 Advantage Business Media survey. Additional statistics from that survey revealed that 70.6 percent of respondents were testing for quality, 57.7 percent were testing for consistency, and 56.5 percent were conducting food safety tests for pathogens. Some 29.4 percent were testing for packaging accuracy claims, and 23.5 percent were testing for the presence of reported and unreported allergens.<sup id=\"rdp-ebb-cite_ref-FLynnFood13_6-1\" class=\"reference\"><a href=\"#cite_note-FLynnFood13-6\">[6]<\/a><\/sup> More recent survey data is difficult to find, so it's not clear how these numbers compare to the realities of 2022. We can say that at least as of 2020, pathogen testing remained vital, with testing of <i>Listeria<\/i> proving a fast-growing subcategory of pathogen testing, primarily for environmental monitoring of the production facility.<sup id=\"rdp-ebb-cite_ref-FergusonTrends20_8-1\" class=\"reference\"><a href=\"#cite_note-FergusonTrends20-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FergusonAnal20_9-1\" class=\"reference\"><a href=\"#cite_note-FergusonAnal20-9\">[9]<\/a><\/sup> A 2020 survey by Strategic Consulting, Inc. further indicated that the volume of microbiology testing is growing at roughly five percent, while pathogen testing volume is growing at roughly six to seven percent, adding that \"outsourcing is driving the volume of tests being sent to commercial labs by as much as 10 percent.\"<sup id=\"rdp-ebb-cite_ref-FergusonAnal20_9-2\" class=\"reference\"><a href=\"#cite_note-FergusonAnal20-9\">[9]<\/a><\/sup> The same surveyor increased those percentages the following year.<sup id=\"rdp-ebb-cite_ref-FergusonFood21_11-0\" class=\"reference\"><a href=\"#cite_note-FergusonFood21-11\">[11]<\/a><\/sup> \n<\/p><p>Finally, Strategic Consulting's Bob Ferguson added that <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) is seeing an uptick in food and beverage testing as of 2021<sup id=\"rdp-ebb-cite_ref-FergusonFoodTwo21_12-0\" class=\"reference\"><a href=\"#cite_note-FergusonFoodTwo21-12\">[12]<\/a><\/sup>:\n<\/p>\n<blockquote><p>As processors outsource their samples, PCR seems to be more frequently selected as the analytical method used than it was when the samples were analyzed in-plant. This possibility certainly makes sense. PCR requires expensive instrumentation and technical expertise to analyze samples properly. Every commercial lab will have a level of analyst capabilities and infrastructure that allows them to use PCR. Commercial labs will also have a high incentive to recommend the use of PCR to optimize the throughput of their instruments.<\/p><\/blockquote>\n<p>So far, we've spoken broadly of the food and beverage laboratory, the roles it can play in the industry, and the testing found in it. The following subsections more closely examine the three roles labs can play, as well as the testing found within those roles.\n<\/p>\n<h4><span id=\"rdp-ebb-1.2.1_R&D_roles_and_testing\"><\/span><span class=\"mw-headline\" id=\"1.2.1_R.26D_roles_and_testing\">1.2.1 R&D roles and testing<\/span><\/h4>\n<div class=\"floatleft\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Food_lab_scientist_packages_food_for_spaceflight_at_Space_Food_Lab.jpg\" class=\"image wiki-link\" data-key=\"f4f81b52e6f9f417c0c975a85b5cd10f\"><img alt=\"Food lab scientist packages food for spaceflight at Space Food Lab.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/4\/49\/Food_lab_scientist_packages_food_for_spaceflight_at_Space_Food_Lab.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>The laboratory participating in this role is performing one or more tasks that relate to the development or improvement of a food, beverage, additive, or spice. This often leads to a commercial formulation, which has the \"necessary details required to scale and produce your [food or beverage] in a consistent, efficient, and safe manner.\"<sup id=\"rdp-ebb-cite_ref-BSCommForm_13-0\" class=\"reference\"><a href=\"#cite_note-BSCommForm-13\">[13]<\/a><\/sup> Even packaging solutions are targets for R&D labs in the food and beverage industry.<sup id=\"rdp-ebb-cite_ref-GudeSol19_14-0\" class=\"reference\"><a href=\"#cite_note-GudeSol19-14\">[14]<\/a><\/sup>\n<\/p><p>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_15-0\" class=\"reference\"><a href=\"#cite_note-MonBreak16-15\">[15]<\/a><\/sup> Other companies may take their R&D to a third-party lab dedicated to conducting development and formulation activities for manufacturers.<sup id=\"rdp-ebb-cite_ref-BSCommForm_13-1\" class=\"reference\"><a href=\"#cite_note-BSCommForm-13\">[13]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GudeSol19_14-1\" class=\"reference\"><a href=\"#cite_note-GudeSol19-14\">[14]<\/a><\/sup> Food and beverage research activities aren't confined to manufacturers, however. Some higher education institutions, such as the Hartwick College Center for Craft Food & Beverage, 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_16-0\" class=\"reference\"><a href=\"#cite_note-HartFoodBev-16\">[16]<\/a><\/sup> \n<\/p><p>Food and beverage R&D labs may work towards improving packaging, testing a product's shelf life (i.e., stability), conducting flavor or aroma analysis, developing and innovating foodstuffs, reformulating existing products, and researching genetic modifications to ingredients. The end user benefits by having fresher foods that are culinarily pleasing, more nutritious, and safer for consumption.\n<\/p><p>The following types of testing may be associated with the R&D role:\n<\/p><p><b>Overall food innovation and development<\/b>: International Center for Food Chain and Network Research's Schiefer and Deiters note that the food and beverage industry as a whole faces a number of significant challenges today, including economic and noneconomic changes, consumer lifestyle changes, global increases in food consumption, degradation and loss of cropland, and societal changes to attitudes concerning sustainability.<sup id=\"rdp-ebb-cite_ref-GalanakisInoov-1_21_17-0\" class=\"reference\"><a href=\"#cite_note-GalanakisInoov-1_21-17\">[17]<\/a><\/sup> These types of challenges require a food and beverage industry that is more agile and innovative, one that is making impactful breakthroughs to improve the quality and range of products, increasing the capacity for making products, replacing outdated products, developing more flexible or sustainable processes, and improving health and safety.<sup id=\"rdp-ebb-cite_ref-GalanakisInoov-2_21_18-0\" class=\"reference\"><a href=\"#cite_note-GalanakisInoov-2_21-18\">[18]<\/a><\/sup> Given the broad scope of efforts involved, the laboratory services for such impactful R&D efforts can vary widely depending on the goal. Improving the flavor of plant-based meat substitutes, for example, comes with somewhat different analytical techniques and disciplinary requirements than say improving the three-dimensional food printing of said meat substitutes.<sup id=\"rdp-ebb-cite_ref-PatelBev21_19-0\" class=\"reference\"><a href=\"#cite_note-PatelBev21-19\">[19]<\/a><\/sup>\n<\/p><p><b>Aroma\/flavor analysis and formulation<\/b>: Here the concept of \"sensomic\" study, an approach to describing the sensory properties of foodstuffs at a molecular level<sup id=\"rdp-ebb-cite_ref-VrzalSenso19_20-0\" class=\"reference\"><a href=\"#cite_note-VrzalSenso19-20\">[20]<\/a><\/sup>, plays an increasingly important role.<sup id=\"rdp-ebb-cite_ref-VrzalSenso19_20-1\" class=\"reference\"><a href=\"#cite_note-VrzalSenso19-20\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ParkerFlav14_21-0\" class=\"reference\"><a href=\"#cite_note-ParkerFlav14-21\">[21]<\/a><\/sup> This involves analytical techniques such as gas chromatography, liquid chromatography, and spectrophotometry, used in conjunction with chemometric data analysis to isolate and act upon volatile compounds from one or more samples.<sup id=\"rdp-ebb-cite_ref-VrzalSenso19_20-2\" class=\"reference\"><a href=\"#cite_note-VrzalSenso19-20\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ParkerFlav14_21-1\" class=\"reference\"><a href=\"#cite_note-ParkerFlav14-21\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NolletHand-4_15_22-0\" class=\"reference\"><a href=\"#cite_note-NolletHand-4_15-22\">[22]<\/a><\/sup> Aroma tends to be a more difficult concept to tackle as we've identified more than a 1,000 volatile compounds in a singular substance such as cooked meats and coffees (though typically only a small number of those compounds make a significant contribution to the overall perceived aroma<sup id=\"rdp-ebb-cite_ref-NolletHand-4_15_22-1\" class=\"reference\"><a href=\"#cite_note-NolletHand-4_15-22\">[22]<\/a><\/sup>), which in turn adds further complexity to overall perception of flavor.<sup id=\"rdp-ebb-cite_ref-ParkerFlav14_21-2\" class=\"reference\"><a href=\"#cite_note-ParkerFlav14-21\">[21]<\/a><\/sup> This gives laboratory researchers formulating a product for a distinct flavor profile more than a few challenges in, for example, putting together a successful mapping of chemical composition to flavor perception.<sup id=\"rdp-ebb-cite_ref-23\" class=\"reference\"><a href=\"#cite_note-23\">[23]<\/a><\/sup>\n<\/p><p><b>Genetic modification for improved yields and nutrition<\/b>: The preface of Westin Carrillo's book <i>Biotechnology and Food Production<\/i> summarizes this activity well. \"Biotechnology can be used in many ways to achieve higher yields; for example, by improving flowering capacity and increasing photosynthesis or the intake of nutritive elements,\" he says. \"In the long term, genetic engineering will also help to increase production of the most valuable components of specific crops\" like cassava and rice, as well as modify their amino acid composition in order to increase their otherwise deficient nutritional value.<sup id=\"rdp-ebb-cite_ref-CarrilloBio20_24-0\" class=\"reference\"><a href=\"#cite_note-CarrilloBio20-24\">[24]<\/a><\/sup> As this suggests, however, knowledge and skills in genetic analysis, modification, and expression are required, in turn requiring the equipment and skill for <a href=\"https:\/\/www.limswiki.org\/index.php\/Sequencing\" class=\"mw-disambig wiki-link\" title=\"Sequencing\" data-key=\"e36167a9eb152ca16a0c4c4e6d13f323\">genetic sequencing<\/a>, microbial transformation, genetic use restriction technology (GURT), Northern or Western blotting, <a href=\"https:\/\/www.limswiki.org\/index.php\/Reverse_transcription_polymerase_chain_reaction\" title=\"Reverse transcription polymerase chain reaction\" class=\"wiki-link\" data-key=\"bb69657b45c41e6345baf4c8067c7aa3\">reverse transcription polymerase chain reaction<\/a> (RT-PCR), etc.<sup id=\"rdp-ebb-cite_ref-CarrilloBio20_24-1\" class=\"reference\"><a href=\"#cite_note-CarrilloBio20-24\">[24]<\/a><\/sup> Admittedly, this type of R&D may fall more firmly in the hands of agriculture businesses than food and beverage businesses themselves. However, a few food and beverage business may bring their genetic modification R&D efforts in-house as an overall effort to improve a majority of its products.\n<\/p><p><b>Nutritional reformulation<\/b>: As various scientific understandings improve and societies shift their desires and perspectives towards processed foods, so too do the formulations used by food processors. Food scientist and author Maurice O'Sullivan describes four primary drivers for these types of reformulations<sup id=\"rdp-ebb-cite_ref-OSullivanSalt20_25-0\" class=\"reference\"><a href=\"#cite_note-OSullivanSalt20-25\">[25]<\/a><\/sup>:\n<\/p>\n<ul><li>Society improves its scientific understanding of the major consumption-related diseases affecting human civilization, including coronary heart disease, diabetes, hypertension, and obesity.<\/li>\n<li>The population at large becomes more aware of scientists' greater understanding of consumption-related diseases.<\/li>\n<li>Food producers inevitably see reason to make changes to their foods based on both the scientific and customer-based factors that affect sales of the producers' products.<\/li>\n<li>Government further provides incentive to the producer to modify their product, through industry collaboration or outright regulation and enforcement activities.<\/li><\/ul>\n<p>O'Sullivan argues that the three most significant components of food that need to be modified are salt, fat, and sugar. Balancing these in reformulations is indeed challenging for chemical, sensory, and other reasons.<sup id=\"rdp-ebb-cite_ref-OSullivanSalt20_25-1\" class=\"reference\"><a href=\"#cite_note-OSullivanSalt20-25\">[25]<\/a><\/sup> Adjusting salt levels, for example, requires chemical knowledge about salt reduction's effects on meat's shelf life and what substitutes or additives can be used to balance out the reduced salt content.<sup id=\"rdp-ebb-cite_ref-KlossSodium15_26-0\" class=\"reference\"><a href=\"#cite_note-KlossSodium15-26\">[26]<\/a><\/sup> As such, reformulation requires a broad array of analytical techniques and industry knowledge, varying based upon the component sought out for change.\n<\/p><p><b>Stability, cycle, and challenge testing<\/b>: As hinted at in the prior subsection, salt plays an important role in the shelf life of meats and other foodstuffs.<sup id=\"rdp-ebb-cite_ref-KlossSodium15_26-1\" class=\"reference\"><a href=\"#cite_note-KlossSodium15-26\">[26]<\/a><\/sup> However, it also can be a leading contributor to cardiovascular complications.<sup id=\"rdp-ebb-cite_ref-OSullivanSalt20_25-2\" class=\"reference\"><a href=\"#cite_note-OSullivanSalt20-25\">[25]<\/a><\/sup> Finding a balance between a more nutritious product and a more shelf-stable product proves to be quite tricky. This is one of several conundrums the stability testing laboratory faces in the food and beverage industry. Multiple deteriorative catalysts can influence the shelf life of a product, from microbiological contaminants and chemical deterioration to storage conditions and the packaging itself. As such, there are multiple approaches to those catalysts, from introducing additives to improving the packaging.<sup id=\"rdp-ebb-cite_ref-SubramaniamTheStab16_27-0\" class=\"reference\"><a href=\"#cite_note-SubramaniamTheStab16-27\">[27]<\/a><\/sup> 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_27-1\" class=\"reference\"><a href=\"#cite_note-SubramaniamTheStab16-27\">[27]<\/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-28\" class=\"reference\"><a href=\"#cite_note-28\">[28]<\/a><\/sup> Calorimetry, spectrophotometry, spectroscopy, and hyperspectral imaging can be used to properly assess color, which has been shown to be a good gauge of food quality.<sup id=\"rdp-ebb-cite_ref-SubramaniamTheStab16_27-2\" class=\"reference\"><a href=\"#cite_note-SubramaniamTheStab16-27\">[27]<\/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_27-3\" class=\"reference\"><a href=\"#cite_note-SubramaniamTheStab16-27\">[27]<\/a><\/sup>\n<\/p><p><b>Packaging analysis and extractable and leachable testing<\/b>: Materials that contact food and beverages 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-29\" class=\"reference\"><a href=\"#cite_note-29\">[29]<\/a><\/sup> As such, attempting to break new ground in food and beverage packaging development can be a tricky matter. Concerns of chemicals and elements that can be extracted or leach into food contact materials add another layer of complexity to developing and choosing packaging materials for foods and beverages. 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-BaloghTesting11_30-0\" class=\"reference\"><a href=\"#cite_note-BaloghTesting11-30\">[30]<\/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_31-0\" class=\"reference\"><a href=\"#cite_note-LAExtract-31\">[31]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"1.2.2_Pre-manufacturing_and_manufacturing_roles_and_testing\">1.2.2 Pre-manufacturing and manufacturing roles and testing<\/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> (i.e., manufacturing) tasks of food and beverage production. Preparative work such as caloric and nutritional analysis may happen in a variety of contexts, from inside the R&D lab to in the manufacturing facility's lab itself, if it has one. This work may also be conducted by a third-party lab, or it may even be performed using non-laboratory techniques such as food composition database analysis.<sup id=\"rdp-ebb-cite_ref-ESHAHow14_32-0\" class=\"reference\"><a href=\"#cite_note-ESHAHow14-32\">[32]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NohRecent20_33-0\" class=\"reference\"><a href=\"#cite_note-NohRecent20-33\">[33]<\/a><\/sup> However, caloric and nutritional testing\u2014in conjunction with meeting regulatory-driven labeling requirements\u2014still lands firmly in the role of pre-manufacturing activity, definitively after commercial formulation and packing requirements have been finalized but before the formal manufacturing process has begun.<sup id=\"rdp-ebb-cite_ref-BSNutTest_34-0\" class=\"reference\"><a href=\"#cite_note-BSNutTest-34\">[34]<\/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_35-0\" class=\"reference\"><a href=\"#cite_note-CA80-2020-35\">[35]<\/a><\/sup> The end user benefits from these caloric, nutritional, and allergen analysis activities not only through the provision of a more transparent window into what they are consuming; these laboratory activities also can better ensure end users' attempts at maintaining their own good health. \n<\/p><p>Finally, laboratory testing can also be found along the production chain in the manufacturing facility itself. This type of testing is couched as quality control testing, primarily, or as <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_assurance\" title=\"Quality assurance\" class=\"wiki-link\" data-key=\"2ede4490f0ea707b14456f44439c0984\">quality assurance<\/a>, secondarily. Some of this analysis may be integrated into the production workflow, as with x-ray inspection.<sup id=\"rdp-ebb-cite_ref-DrausQual17_36-0\" class=\"reference\"><a href=\"#cite_note-DrausQual17-36\">[36]<\/a><\/sup> Fluorescence sensing technologies are also useful for contaminant testing, though they are largely limited to laboratory use, with hopes they may become more relevant for inspection at the point of production.<sup id=\"rdp-ebb-cite_ref-HanPersp20_37-0\" class=\"reference\"><a href=\"#cite_note-HanPersp20-37\">[37]<\/a><\/sup> This move to \"novel, rapid, and non-destructive\" methods of testing both in the lab and in the production facility appears to be a growing trend<sup id=\"rdp-ebb-cite_ref-\" class=\"reference\"><a href=\"#cite_note-\">[38]<\/a><\/sup>, loosening the concept of the \"quality control laboratory\" as an entity in the production facility. Regardless of analytical location, the quality control lab provides benefits to society by being a critical component of an overall <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> that better ensures the safety of those consuming the final product.\n<\/p><p>The following types of testing may be associated with the pre-manufacturing and manufacturing role:\n<\/p><p><b>Allergen, calorie, and nutrition testing<\/b>: From label accuracy to consumer safety, this type of testing is critical to food and beverage manufacturers. Caloric and nutritional testing\u2014in conjunction with 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_34-1\" class=\"reference\"><a href=\"#cite_note-BSNutTest-34\">[34]<\/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_35-1\" class=\"reference\"><a href=\"#cite_note-CA80-2020-35\">[35]<\/a><\/sup> This role will usually require laboratory analytical techniques such as calorimetry, laser scanning confocal microscopy, immunoassays, and mass spectrometry.<sup id=\"rdp-ebb-cite_ref-DimitrovaNut19_39-0\" class=\"reference\"><a href=\"#cite_note-DimitrovaNut19-39\">[39]<\/a><\/sup> Note, however, that non-laboratory techniques such as food composition database analysis are also used to evaluate the nutritional content of products that aren't heavily processed.<sup id=\"rdp-ebb-cite_ref-ESHAHow14_32-1\" class=\"reference\"><a href=\"#cite_note-ESHAHow14-32\">[32]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NohRecent20_33-1\" class=\"reference\"><a href=\"#cite_note-NohRecent20-33\">[33]<\/a><\/sup>\n<\/p><p><b>Quality control testing<\/b>: A food or beverage product's launch success hinges on many variables; if one variable is off, it may very well be rejected by the consumer. Producers invest significantly in a product they believe in, requiring assurances along the way that it will have its best chance of success. The producer will want to ensure high-quality raw ingredients, high-quality equipment, an effective processing layout, and high customer satisfaction. A well-implemented <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) plays a major role in ensuring those requirements, and by extension that includes a type of testing couched as quality control testing, primarily, or as quality assurance testing, secondarily.<sup id=\"rdp-ebb-cite_ref-40\" class=\"reference\"><a href=\"#cite_note-40\">[40]<\/a><\/sup> Many aspects of food and beverage production require high levels of quality, and as such, the type of analytical testing that takes place will vary, sometimes significantly, depending upon the associated risk. Are microbiological, physiological, or chemical risks being managed? These and other questions will determine the laboratory approach to quality, which is in turn ideally reflected in the QMS.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"1.2.3_Post-production_regulation_and_security_roles_and_testing\">1.2.3 Post-production regulation and security roles and testing<\/span><\/h4>\n<p>The laboratory participating in these roles is performing one or more tasks that relate to the post-production examination of foods and beverages for regulatory, security, or accreditation purposes. This type of testing examines raw ingredients, consumable products, and packaging found not only in a production facility but also in locations such as shipping docks, farms, grocery stores, and more. 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 the source of a foodborne illness. In the last case, the lab may not even be a traditional \"food and beverage\" lab but rather a <a href=\"https:\/\/www.limswiki.org\/index.php\/Public_health_laboratory\" title=\"Public health laboratory\" class=\"wiki-link\" data-key=\"34ffb658cb79bf322c65efaad95996f5\">public health laboratory<\/a>, highlighting in full the human safety elements associated with our food and water supplies. The human safety element is also seen in government labs such as the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service's (FSIS) Field Service Laboratories, which \"coordinate and conduct laboratory analytical services in support of the Agency's farm-to-table strategies in the disciplines of chemistry, microbiology, and pathology for food safety in meat, poultry, and egg products.\"<sup id=\"rdp-ebb-cite_ref-FSISLabs_41-0\" class=\"reference\"><a href=\"#cite_note-FSISLabs-41\">[41]<\/a><\/sup> In addition to ensuring a safer food supply, 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 testing may be associated with the post-production regulation and security role:\n<\/p><p><b>Authenticity and adulteration testing<\/b>: A variety of local, regional, national, and international entities (e.g., Operation OPSON, E.U. Food Fraud Network, and U.S. Customs and Border Protection) are responsible for detecting and preventing violations of food supply chain laws and regulations across national and international borders, while also collecting evidence for investigation and prosecution. \"To support these regulatory and commercial initiatives,\" says Gerard Downey of the Teagasc Food Research Centre, \"research scientists have devoted considerable resources to the development 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-42\" class=\"reference\"><a href=\"#cite_note-42\">[42]<\/a><\/sup>\n<\/p><p><b>Accreditation-led testing<\/b>: At the end of 2021, the FDA amended the FSMA to include the LAAF rule, which mandates laboratory \"testing of food in certain circumstances\" be performed by LAAF-accredited laboratories. This accreditation is optional and designed for those accreditation bodies and laboratories that have been or are seeking to be be recognized by the FDA as able to LAAF-accredit or be LAAF-accredited for the testing needs of the program. LAAF's \"certain circumstances\" include not only regulatory-based testing of specific sprouts, eggs, and water, but also certain foods being considered for import into the country.<sup id=\"rdp-ebb-cite_ref-DouglasFDA22_43-0\" class=\"reference\"><a href=\"#cite_note-DouglasFDA22-43\">[43]<\/a><\/sup> LAAF represents one of several legal and regulatory forces driving accreditation of food and beverage laboratories to a higher standard. It also means greater potential for more testing opportunities for the third-party food and beverage lab wishing to expand into enforcement and security roles. The type of testing they conduct will already mirror those of other roles mentioned prior, but with greater emphasis on meeting stricter testing requirements.\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 food and beverage facility. However, some level of laboratory work is required in these roles, which intersect with the food and beverage 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_44-0\" class=\"reference\"><a href=\"#cite_note-HoSanit20-44\">[44]<\/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_44-1\" class=\"reference\"><a href=\"#cite_note-HoSanit20-44\">[44]<\/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_44-2\" class=\"reference\"><a href=\"#cite_note-HoSanit20-44\">[44]<\/a><\/sup> These SSOPs are not only driven by good manufacturing practice (GMP) but also appropriate and effective laboratory testing. That foundation of laboratory testing has occurred historically with the experience of food and beverage producers and those engineering and standardizing hygienic solutions for the industry. 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 \"fundamental hygienic requirements for product contact surfaces and food equipment,\" ranging from 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-45\" class=\"reference\"><a href=\"#cite_note-45\">[45]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EUSelect20_46-0\" class=\"reference\"><a href=\"#cite_note-EUSelect20-46\">[46]<\/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_46-1\" class=\"reference\"><a href=\"#cite_note-EUSelect20-46\">[46]<\/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>Public health and clinical diagnostics for foodborne illness<\/b>: While <a href=\"https:\/\/www.limswiki.org\/index.php\/Public_health_laboratory\" title=\"Public health laboratory\" class=\"wiki-link\" data-key=\"34ffb658cb79bf322c65efaad95996f5\">public health<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_laboratory\" title=\"Clinical laboratory\" class=\"wiki-link\" data-key=\"307bcdf1bdbcd1bb167cee435b7a5463\">clinical diagnostic laboratories<\/a> are indeed of a different ilk, they are undoubtedly intertwined with the food and beverage industry. With millions of people getting sick and thousands hospitalized and dying from foodborne diseases each year in the U.S. alone<sup id=\"rdp-ebb-cite_ref-CDCBurdenFood18_47-0\" class=\"reference\"><a href=\"#cite_note-CDCBurdenFood18-47\">[47]<\/a><\/sup>, this fact becomes clearer. When the food and beverage industry's SSOP- and QMS-related activities go awry\u2014knowingly or unknowingly\u2014or if the consumer does not follow proper precautions with the foods and beverages they consume, <a href=\"https:\/\/www.limswiki.org\/index.php\/Public_health_laboratory\" title=\"Public health laboratory\" class=\"wiki-link\" data-key=\"34ffb658cb79bf322c65efaad95996f5\">public health<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_laboratory\" title=\"Clinical laboratory\" class=\"wiki-link\" data-key=\"307bcdf1bdbcd1bb167cee435b7a5463\">clinical laboratories<\/a> may get involved in tracking the source of the pathogen or treating the foodborne illness, respectively. As previous discussion has noted<sup id=\"rdp-ebb-cite_ref-DouglasWhatIs22_48-0\" class=\"reference\"><a href=\"#cite_note-DouglasWhatIs22-48\">[48]<\/a><\/sup>, the interest of public health is at the foundation of the historical and regulatory development of the modern food and beverage industry. In the U.S., the presence of these labs is characterized by efforts such as FoodNet, a CDC program that 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_49-0\" class=\"reference\"><a href=\"#cite_note-CDCAboutFN21-49\">[49]<\/a><\/sup> As a public health tool, FoodNet helps track rates of illness from foodborne pathogens. Through its Diagnostic Laboratory Practices Tool, the public health tool extends into the clinical diagnostics realm, recruiting nearly 700 of those labs to report on their testing practices in regards to select enteric pathogens. From there, one can glean the test methods and specimen submissions being conducted.<sup id=\"rdp-ebb-cite_ref-CDCLabSurv_50-0\" class=\"reference\"><a href=\"#cite_note-CDCLabSurv-50\">[50]<\/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-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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_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 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=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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-IFTDiverse20-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-IFTDiverse20_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ift.org\/news-and-publications\/news\/2020\/october\/26\/diverse-skill-sets-needed-for-growing-opportunities\" target=\"_blank\">\"Diverse skill sets needed for growing opportunities\"<\/a>. Institute of Food Technologists. 26 October 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.ift.org\/news-and-publications\/news\/2020\/october\/26\/diverse-skill-sets-needed-for-growing-opportunities\" target=\"_blank\">https:\/\/www.ift.org\/news-and-publications\/news\/2020\/october\/26\/diverse-skill-sets-needed-for-growing-opportunities<\/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=Diverse+skill+sets+needed+for+growing+opportunities&rft.atitle=&rft.date=26+October+2020&rft.pub=Institute+of+Food+Technologists&rft_id=https%3A%2F%2Fwww.ift.org%2Fnews-and-publications%2Fnews%2F2020%2Foctober%2F26%2Fdiverse-skill-sets-needed-for-growing-opportunities&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FLynnFood13-6\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-FLynnFood13_6-0\">6.0<\/a><\/sup> <sup><a href=\"#cite_ref-FLynnFood13_6-1\">6.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Flynn, D. (7 October 2013). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.foodsafetynews.com\/2013\/10\/food-labs-integral-to-changing-world-of-food-safety\/\" target=\"_blank\">\"Food Labs Integral to Changing World of Food Safety\"<\/a>. <i>Food Safety News<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.foodsafetynews.com\/2013\/10\/food-labs-integral-to-changing-world-of-food-safety\/\" target=\"_blank\">https:\/\/www.foodsafetynews.com\/2013\/10\/food-labs-integral-to-changing-world-of-food-safety\/<\/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=Food+Labs+Integral+to+Changing+World+of+Food+Safety&rft.atitle=Food+Safety+News&rft.aulast=Flynn%2C+D.&rft.au=Flynn%2C+D.&rft.date=7+October+2013&rft_id=https%3A%2F%2Fwww.foodsafetynews.com%2F2013%2F10%2Ffood-labs-integral-to-changing-world-of-food-safety%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FergusonOutsou17-7\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-FergusonOutsou17_7-0\">7.0<\/a><\/sup> <sup><a href=\"#cite_ref-FergusonOutsou17_7-1\">7.1<\/a><\/sup> <sup><a href=\"#cite_ref-FergusonOutsou17_7-2\">7.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Ferguson, B. (12 December 2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.food-safety.com\/articles\/5584-outsourcing-pathogen-testing-under-the-microscope\" target=\"_blank\">\"Outsourcing: Pathogen Testing under the Microscope\"<\/a>. <i>Food Safety Magazine<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.food-safety.com\/articles\/5584-outsourcing-pathogen-testing-under-the-microscope\" target=\"_blank\">https:\/\/www.food-safety.com\/articles\/5584-outsourcing-pathogen-testing-under-the-microscope<\/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=Outsourcing%3A+Pathogen+Testing+under+the+Microscope&rft.atitle=Food+Safety+Magazine&rft.aulast=Ferguson%2C+B.&rft.au=Ferguson%2C+B.&rft.date=12+December+2017&rft_id=https%3A%2F%2Fwww.food-safety.com%2Farticles%2F5584-outsourcing-pathogen-testing-under-the-microscope&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FergusonTrends20-8\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-FergusonTrends20_8-0\">8.0<\/a><\/sup> <sup><a href=\"#cite_ref-FergusonTrends20_8-1\">8.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Ferguson, B. 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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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MonBreak16-15\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MonBreak16_15-0\">\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 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=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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HartFoodBev-16\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HartFoodBev_16-0\">\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>. 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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=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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GalanakisInoov-1_21-17\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GalanakisInoov-1_21_17-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Schiefer, G.; Deiters, J. (2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=jqZJEAAAQBAJ\" target=\"_blank\">\"Chapter 1: Food innovation dynamics and network support\"<\/a>. In Galanakis, Charis Michael (in en). <i>Innovation Strategies in the Food Industry: Tools for Implementation<\/i>. Academic Press. pp. 3\u201316. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-323-91552-6<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=jqZJEAAAQBAJ\" target=\"_blank\">https:\/\/books.google.com\/books?id=jqZJEAAAQBAJ<\/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+Food+innovation+dynamics+and+network+support&rft.atitle=Innovation+Strategies+in+the+Food+Industry%3A+Tools+for+Implementation&rft.aulast=Schiefer%2C+G.%3B+Deiters%2C+J.&rft.au=Schiefer%2C+G.%3B+Deiters%2C+J.&rft.date=2021&rft.pages=pp.%26nbsp%3B3%E2%80%9316&rft.pub=Academic+Press&rft.isbn=978-0-323-91552-6&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DjqZJEAAAQBAJ&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GalanakisInoov-2_21-18\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GalanakisInoov-2_21_18-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Bigliardi, B.; Filippelli, S. 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Academic Press. pp. 17\u201338. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-323-91552-6<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=jqZJEAAAQBAJ\" target=\"_blank\">https:\/\/books.google.com\/books?id=jqZJEAAAQBAJ<\/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+2%3A+Open+innovation+and+incorporation+between+academia+and+the+food+industry&rft.atitle=Innovation+Strategies+in+the+Food+Industry%3A+Tools+for+Implementation&rft.aulast=Bigliardi%2C+B.%3B+Filippelli%2C+S.&rft.au=Bigliardi%2C+B.%3B+Filippelli%2C+S.&rft.date=2021&rft.pages=pp.%26nbsp%3B17%E2%80%9338&rft.pub=Academic+Press&rft.isbn=978-0-323-91552-6&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DjqZJEAAAQBAJ&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PatelBev21-19\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PatelBev21_19-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Patel, P. (18 February 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/spectrum.ieee.org\/3d-printed-meat\" target=\"_blank\">\"Beyond Burgers: Animal and Plant Cells Combined for 3D-Printed Steaks\"<\/a>. <i>IEEE Spectrum<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/spectrum.ieee.org\/3d-printed-meat\" target=\"_blank\">https:\/\/spectrum.ieee.org\/3d-printed-meat<\/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=Beyond+Burgers%3A+Animal+and+Plant+Cells+Combined+for+3D-Printed+Steaks&rft.atitle=IEEE+Spectrum&rft.aulast=Patel%2C+P.&rft.au=Patel%2C+P.&rft.date=18+February+2021&rft_id=https%3A%2F%2Fspectrum.ieee.org%2F3d-printed-meat&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-VrzalSenso19-20\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-VrzalSenso19_20-0\">20.0<\/a><\/sup> <sup><a href=\"#cite_ref-VrzalSenso19_20-1\">20.1<\/a><\/sup> <sup><a href=\"#cite_ref-VrzalSenso19_20-2\">20.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Vrzal, Tom\u00e1\u0161; Ol\u0161ovsk\u00e1, Jana (15 October 2019). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.kvasnyprumysl.eu\/index.php\/kp\/article\/view\/190\" target=\"_blank\">\"Sensomics - basic principles and practice\"<\/a>. <i>KVASNY PRUMYSL<\/i> <b>65<\/b> (5). <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\/10.18832%2Fkp2019.65.166\" target=\"_blank\">10.18832\/kp2019.65.166<\/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\/2570-8619\" target=\"_blank\">2570-8619<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.kvasnyprumysl.eu\/index.php\/kp\/article\/view\/190\" target=\"_blank\">http:\/\/www.kvasnyprumysl.eu\/index.php\/kp\/article\/view\/190<\/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=Sensomics+-+basic+principles+and+practice&rft.jtitle=KVASNY+PRUMYSL&rft.aulast=Vrzal&rft.aufirst=Tom%C3%A1%C5%A1&rft.au=Vrzal%2C%26%2332%3BTom%C3%A1%C5%A1&rft.au=Ol%C5%A1ovsk%C3%A1%2C%26%2332%3BJana&rft.date=15+October+2019&rft.volume=65&rft.issue=5&rft_id=info:doi\/10.18832%2Fkp2019.65.166&rft.issn=2570-8619&rft_id=http%3A%2F%2Fwww.kvasnyprumysl.eu%2Findex.php%2Fkp%2Farticle%2Fview%2F190&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ParkerFlav14-21\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ParkerFlav14_21-0\">21.0<\/a><\/sup> <sup><a href=\"#cite_ref-ParkerFlav14_21-1\">21.1<\/a><\/sup> <sup><a href=\"#cite_ref-ParkerFlav14_21-2\">21.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Parker, J.K.; Elmore, J.S.; Methven, L., ed. (2014). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=DnB7AwAAQBAJ&printsec=frontcover\" target=\"_blank\"><i>Flavour development, analysis and perception in food and beverages<\/i><\/a>. Woodhead Publishing Series in Food Science, Technology and Nutrition. Waltham, MA: Woodhead Pub. pp. 448. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-1-78242-103-0<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=DnB7AwAAQBAJ&printsec=frontcover\" target=\"_blank\">https:\/\/books.google.com\/books?id=DnB7AwAAQBAJ&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=Flavour+development%2C+analysis+and+perception+in+food+and+beverages&rft.date=2014&rft.series=Woodhead+Publishing+Series+in+Food+Science%2C+Technology+and+Nutrition&rft.pages=pp.%26nbsp%3B448&rft.place=Waltham%2C+MA&rft.pub=Woodhead+Pub&rft.isbn=978-1-78242-103-0&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DDnB7AwAAQBAJ%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NolletHand-4_15-22\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-NolletHand-4_15_22-0\">22.0<\/a><\/sup> <sup><a href=\"#cite_ref-NolletHand-4_15_22-1\">22.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Zellner, B.d'A.; Dugo, P.; Dugo, G. et al. (2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=KtAdCgAAQBAJ&printsec=frontcover\" target=\"_blank\">\"Chapter 4: Flavor\"<\/a>. In Nollet, L.M.L.; Toldr\u00e1, F.. <i>Handbook of Food Analysis (Two Volume Set)<\/i> (3rd ed.). CRC Press. pp. 47\u201364. <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=bookitem&rft.btitle=Chapter+4%3A+Flavor&rft.atitle=Handbook+of+Food+Analysis+%28Two+Volume+Set%29&rft.aulast=Zellner%2C+B.d%27A.%3B+Dugo%2C+P.%3B+Dugo%2C+G.+et+al.&rft.au=Zellner%2C+B.d%27A.%3B+Dugo%2C+P.%3B+Dugo%2C+G.+et+al.&rft.date=2015&rft.pages=pp.%26nbsp%3B47%E2%80%9364&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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_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 Journal\">Regueiro, Jorge; Negreira, Noelia; Simal-G\u00e1ndara, Jes\u00fas (3 July 2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/10408398.2015.1048775\" target=\"_blank\">\"Challenges in relating concentrations of aromas and tastes with flavor features of foods\"<\/a> (in en). <i>Critical Reviews in Food Science and Nutrition<\/i> <b>57<\/b> (10): 2112\u20132127. <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\/10.1080%2F10408398.2015.1048775\" target=\"_blank\">10.1080\/10408398.2015.1048775<\/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\/1040-8398\" target=\"_blank\">1040-8398<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/10408398.2015.1048775\" target=\"_blank\">https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/10408398.2015.1048775<\/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=Challenges+in+relating+concentrations+of+aromas+and+tastes+with+flavor+features+of+foods&rft.jtitle=Critical+Reviews+in+Food+Science+and+Nutrition&rft.aulast=Regueiro&rft.aufirst=Jorge&rft.au=Regueiro%2C%26%2332%3BJorge&rft.au=Negreira%2C%26%2332%3BNoelia&rft.au=Simal-G%C3%A1ndara%2C%26%2332%3BJes%C3%BAs&rft.date=3+July+2017&rft.volume=57&rft.issue=10&rft.pages=2112%E2%80%932127&rft_id=info:doi\/10.1080%2F10408398.2015.1048775&rft.issn=1040-8398&rft_id=https%3A%2F%2Fwww.tandfonline.com%2Fdoi%2Ffull%2F10.1080%2F10408398.2015.1048775&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CarrilloBio20-24\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CarrilloBio20_24-0\">24.0<\/a><\/sup> <sup><a href=\"#cite_ref-CarrilloBio20_24-1\">24.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Carrillo, W. (2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=qePEDwAAQBAJ&printsec=frontcover\" target=\"_blank\"><i>Biotechnology and Food Production<\/i><\/a>. ED-Tech Press. pp. 404. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9781839473432<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=qePEDwAAQBAJ&printsec=frontcover\" target=\"_blank\">https:\/\/books.google.com\/books?id=qePEDwAAQBAJ&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=Biotechnology+and+Food+Production&rft.aulast=Carrillo%2C+W.&rft.au=Carrillo%2C+W.&rft.date=2020&rft.pages=pp.%26nbsp%3B404&rft.pub=ED-Tech+Press&rft.isbn=9781839473432&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DqePEDwAAQBAJ%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-OSullivanSalt20-25\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-OSullivanSalt20_25-0\">25.0<\/a><\/sup> <sup><a href=\"#cite_ref-OSullivanSalt20_25-1\">25.1<\/a><\/sup> <sup><a href=\"#cite_ref-OSullivanSalt20_25-2\">25.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">O'Sullivan, Maurice G. (2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=vE_VDwAAQBAJ&printsec=frontcover\" target=\"_blank\">\"Chapter 1: Understanding the requirement to reformulate: Science, health, consumer demand, regulation, and capability\"<\/a>. <i>Salt, fat, and sugar reduction: sensory approaches for nutritional reformulation of foods and beverages<\/i>. Duxford, United Kingdom: Elsevier, Woodhead Publishing. pp. 1\u201328. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-12-819741-7<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=vE_VDwAAQBAJ&printsec=frontcover\" target=\"_blank\">https:\/\/books.google.com\/books?id=vE_VDwAAQBAJ&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+Understanding+the+requirement+to+reformulate%3A+Science%2C+health%2C+consumer+demand%2C+regulation%2C+and+capability&rft.atitle=Salt%2C+fat%2C+and+sugar+reduction%3A+sensory+approaches+for+nutritional+reformulation+of+foods+and+beverages&rft.aulast=O%27Sullivan&rft.aufirst=Maurice+G.&rft.au=O%27Sullivan%2C%26%2332%3BMaurice+G.&rft.date=2020&rft.pages=pp.%26nbsp%3B1%E2%80%9328&rft.place=Duxford%2C+United+Kingdom&rft.pub=Elsevier%2C+Woodhead+Publishing&rft.isbn=978-0-12-819741-7&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DvE_VDwAAQBAJ%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KlossSodium15-26\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-KlossSodium15_26-0\">26.0<\/a><\/sup> <sup><a href=\"#cite_ref-KlossSodium15_26-1\">26.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Kloss, Loreen; Meyer, Julia Dawn; Graeve, Lutz; Vetter, Walter (1 June 2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2352364615000024\" target=\"_blank\">\"Sodium intake and its reduction by food reformulation in the European Union \u2014 A review\"<\/a> (in en). <i>NFS Journal<\/i> <b>1<\/b>: 9\u201319. <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.nfs.2015.03.001\" target=\"_blank\">10.1016\/j.nfs.2015.03.001<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2352364615000024\" target=\"_blank\">https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2352364615000024<\/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=Sodium+intake+and+its+reduction+by+food+reformulation+in+the+European+Union+%E2%80%94+A+review&rft.jtitle=NFS+Journal&rft.aulast=Kloss&rft.aufirst=Loreen&rft.au=Kloss%2C%26%2332%3BLoreen&rft.au=Meyer%2C%26%2332%3BJulia+Dawn&rft.au=Graeve%2C%26%2332%3BLutz&rft.au=Vetter%2C%26%2332%3BWalter&rft.date=1+June+2015&rft.volume=1&rft.pages=9%E2%80%9319&rft_id=info:doi\/10.1016%2Fj.nfs.2015.03.001&rft_id=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS2352364615000024&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SubramaniamTheStab16-27\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-SubramaniamTheStab16_27-0\">27.0<\/a><\/sup> <sup><a href=\"#cite_ref-SubramaniamTheStab16_27-1\">27.1<\/a><\/sup> <sup><a href=\"#cite_ref-SubramaniamTheStab16_27-2\">27.2<\/a><\/sup> <sup><a href=\"#cite_ref-SubramaniamTheStab16_27-3\">27.3<\/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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_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\">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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-29\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-29\">\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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BaloghTesting11-30\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BaloghTesting11_30-0\">\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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LAExtract-31\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LAExtract_31-0\">\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 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=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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ESHAHow14-32\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ESHAHow14_32-0\">32.0<\/a><\/sup> <sup><a href=\"#cite_ref-ESHAHow14_32-1\">32.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/esha.com\/wp-content\/uploads\/2014\/12\/ESHA-Obtaining-Nutritional-Analysis-eBook.pdf\" target=\"_blank\">\"How to Obtain a Nutritional Analysis of Your Food Product\"<\/a> (PDF). ESHA Research. December 2014<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/esha.com\/wp-content\/uploads\/2014\/12\/ESHA-Obtaining-Nutritional-Analysis-eBook.pdf\" target=\"_blank\">https:\/\/esha.com\/wp-content\/uploads\/2014\/12\/ESHA-Obtaining-Nutritional-Analysis-eBook.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+Obtain+a+Nutritional+Analysis+of+Your+Food+Product&rft.atitle=&rft.date=December+2014&rft.pub=ESHA+Research&rft_id=https%3A%2F%2Fesha.com%2Fwp-content%2Fuploads%2F2014%2F12%2FESHA-Obtaining-Nutritional-Analysis-eBook.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NohRecent20-33\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-NohRecent20_33-0\">33.0<\/a><\/sup> <sup><a href=\"#cite_ref-NohRecent20_33-1\">33.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Noh, M.F.M.; Gunasegavan, R.D.-N.; Khalid, N.M. et al. (2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7582643\" target=\"_blank\">\"Recent Techniques in Nutrient Analysis for Food Composition Database\"<\/a>. <i>Molecules<\/i> <b>25<\/b> (19): 4567. <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\/10.3390%2Fmolecules25194567\" target=\"_blank\">10.3390\/molecules25194567<\/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\/PMC7582643\/\" target=\"_blank\">PMC7582643<\/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\/33036314\" target=\"_blank\">33036314<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7582643\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7582643<\/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=Recent+Techniques+in+Nutrient+Analysis+for+Food+Composition+Database&rft.jtitle=Molecules&rft.aulast=Noh%2C+M.F.M.%3B+Gunasegavan%2C+R.D.-N.%3B+Khalid%2C+N.M.+et+al.&rft.au=Noh%2C+M.F.M.%3B+Gunasegavan%2C+R.D.-N.%3B+Khalid%2C+N.M.+et+al.&rft.date=2020&rft.volume=25&rft.issue=19&rft.pages=4567&rft_id=info:doi\/10.3390%2Fmolecules25194567&rft_id=info:pmc\/PMC7582643&rft_id=info:pmid\/33036314&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7582643&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BSNutTest-34\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BSNutTest_34-0\">34.0<\/a><\/sup> <sup><a href=\"#cite_ref-BSNutTest_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.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. 2 December 2022<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=2+December+2022&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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CA80-2020-35\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CA80-2020_35-0\">35.0<\/a><\/sup> <sup><a href=\"#cite_ref-CA80-2020_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.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 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=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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DrausQual17-36\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DrausQual17_36-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Draus, C. (15 November 2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.eaglepi.com\/blog\/quality-control-or-quality-assurance-in-the-food-industry\/\" target=\"_blank\">\"Quality Control or Quality Assurance in the Food Industry?: X-ray Inspection Equipment Ensures Both\"<\/a>. <i>Eagle PI<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.eaglepi.com\/blog\/quality-control-or-quality-assurance-in-the-food-industry\/\" target=\"_blank\">https:\/\/www.eaglepi.com\/blog\/quality-control-or-quality-assurance-in-the-food-industry\/<\/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=Quality+Control+or+Quality+Assurance+in+the+Food+Industry%3F%3A+X-ray+Inspection+Equipment+Ensures+Both&rft.atitle=Eagle+PI&rft.aulast=Draus%2C+C.&rft.au=Draus%2C+C.&rft.date=15+November+2017&rft_id=https%3A%2F%2Fwww.eaglepi.com%2Fblog%2Fquality-control-or-quality-assurance-in-the-food-industry%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HanPersp20-37\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HanPersp20_37-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Han, A.; Hao, S.; Yang, Y. et al. (2020). \"Perspective on recent developments of nanomaterial based fluorescent sensors: applications in safety and quality control of food and beverages\". <i>Journal of Food and Drug Analysis<\/i> <b>28<\/b> (4): 2. <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\/10.38212%2F2224-6614.1270\" target=\"_blank\">10.38212\/2224-6614.1270<\/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=Perspective+on+recent+developments+of+nanomaterial+based+fluorescent+sensors%3A+applications+in+safety+and+quality+control+of+food+and+beverages&rft.jtitle=Journal+of+Food+and+Drug+Analysis&rft.aulast=Han%2C+A.%3B+Hao%2C+S.%3B+Yang%2C+Y.+et+al.&rft.au=Han%2C+A.%3B+Hao%2C+S.%3B+Yang%2C+Y.+et+al.&rft.date=2020&rft.volume=28&rft.issue=4&rft.pages=2&rft_id=info:doi\/10.38212%2F2224-6614.1270&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-38\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-38\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Aadil, R.M.; Madni, G.M.; Roobab, U. et al.. \"Chapter 1. Quality Control in Beverage Production: An Overview\". In Grumezescu, A.M.; Holban, A.M.. <i>Quality Control in the Beverage Industry<\/i>. The Science of Beverages. <b>17<\/b>. Elsevier. pp. 1-38. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780128166826.<\/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.++Quality+Control+in+Beverage+Production%3A+An+Overview&rft.atitle=Quality+Control+in+the+Beverage+Industry&rft.aulast=Aadil%2C+R.M.%3B+Madni%2C+G.M.%3B+Roobab%2C+U.+et+al.&rft.au=Aadil%2C+R.M.%3B+Madni%2C+G.M.%3B+Roobab%2C+U.+et+al.&rft.series=The+Science+of+Beverages&rft.volume=17&rft.pages=pp.%26nbsp%3B1-38&rft.pub=Elsevier&rft.isbn=9780128166826&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DimitrovaNut19-39\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DimitrovaNut19_39-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Dimitrova, M. (8 October 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.azom.com\/article.aspx?ArticleID=18555\" target=\"_blank\">\"Nutrition Analysis Techniques to Determine the Nutritional Content of Food\"<\/a>. <i>AZO Materials<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.azom.com\/article.aspx?ArticleID=18555\" target=\"_blank\">https:\/\/www.azom.com\/article.aspx?ArticleID=18555<\/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=Nutrition+Analysis+Techniques+to+Determine+the+Nutritional+Content+of+Food&rft.atitle=AZO+Materials&rft.aulast=Dimitrova%2C+M.&rft.au=Dimitrova%2C+M.&rft.date=8+October+2019&rft_id=https%3A%2F%2Fwww.azom.com%2Farticle.aspx%3FArticleID%3D18555&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-40\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-40\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Aadil, R.M.; Madni, G.M.; Roobab, U. et al. (2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=2YmpDwAAQBAJ&printsec=frontcover\" target=\"_blank\">\"Chapter 1: Quality Control in Beverage Production: An Overview\"<\/a>. In Grumezescu, A.; Grumezescu, A.M.; Holban, A.M. (in English). <i>Quality Control in the Beverage Industry<\/i>. <b>17<\/b>. Academic Press. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-12-816682-6. <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\/1122792300\" target=\"_blank\">1122792300<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=2YmpDwAAQBAJ&printsec=frontcover\" target=\"_blank\">https:\/\/books.google.com\/books?id=2YmpDwAAQBAJ&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+Quality+Control+in+Beverage+Production%3A+An+Overview&rft.atitle=Quality+Control+in+the+Beverage+Industry&rft.aulast=Aadil%2C+R.M.%3B+Madni%2C+G.M.%3B+Roobab%2C+U.+et+al.&rft.au=Aadil%2C+R.M.%3B+Madni%2C+G.M.%3B+Roobab%2C+U.+et+al.&rft.date=2019&rft.volume=17&rft.pub=Academic+Press&rft.isbn=978-0-12-816682-6&rft_id=info:oclcnum\/1122792300&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3D2YmpDwAAQBAJ%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FSISLabs-41\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FSISLabs_41-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fsis.usda.gov\/science-data\/laboratories-procedures\/fsis-laboratories\" target=\"_blank\">\"FSIS Laboratories\"<\/a>. Food Safety and Inspection Service, U.S. Department of Agriculture. 26 April 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fsis.usda.gov\/science-data\/laboratories-procedures\/fsis-laboratories\" target=\"_blank\">https:\/\/www.fsis.usda.gov\/science-data\/laboratories-procedures\/fsis-laboratories<\/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=FSIS+Laboratories&rft.atitle=&rft.date=26+April+2019&rft.pub=Food+Safety+and+Inspection+Service%2C+U.S.+Department+of+Agriculture&rft_id=https%3A%2F%2Fwww.fsis.usda.gov%2Fscience-data%2Flaboratories-procedures%2Ffsis-laboratories&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_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 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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DouglasFDA22-43\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DouglasFDA22_43-0\">\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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HoSanit20-44\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HoSanit20_44-0\">44.0<\/a><\/sup> <sup><a href=\"#cite_ref-HoSanit20_44-1\">44.1<\/a><\/sup> <sup><a href=\"#cite_ref-HoSanit20_44-2\">44.2<\/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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_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\" 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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-EUSelect20-46\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-EUSelect20_46-0\">46.0<\/a><\/sup> <sup><a href=\"#cite_ref-EUSelect20_46-1\">46.1<\/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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCBurdenFood18-47\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCBurdenFood18_47-0\">\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 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=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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DouglasWhatIs22-48\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DouglasWhatIs22_48-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Douglas, S.E. (16 August 2022). <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"https:\/\/www.limswiki.org\/index.php\/LIMS_FAQ:What_is_the_importance_of_a_food_and_beverage_testing_laboratory_to_society%3F\" data-key=\"70b0b44ac287fc46610413962937a886\">\"What is the importance of a food and beverage testing laboratory to society?\"<\/a>. LIMSwiki<span class=\"printonly\">. <a rel=\"nofollow\" class=\"external free wiki-link\" href=\"https:\/\/www.limswiki.org\/index.php\/LIMS_FAQ:What_is_the_importance_of_a_food_and_beverage_testing_laboratory_to_society%3F\" data-key=\"70b0b44ac287fc46610413962937a886\">https:\/\/www.limswiki.org\/index.php\/LIMS_FAQ:What_is_the_importance_of_a_food_and_beverage_testing_laboratory_to_society%3F<\/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+the+importance+of+a+food+and+beverage+testing+laboratory+to+society%3F&rft.atitle=&rft.aulast=Douglas%2C+S.E.&rft.au=Douglas%2C+S.E.&rft.date=16+August+2022&rft.pub=LIMSwiki&rft_id=https%3A%2F%2Fwww.limswiki.org%2Findex.php%2FLIMS_FAQ%3AWhat_is_the_importance_of_a_food_and_beverage_testing_laboratory_to_society%253F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCAboutFN21-49\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCAboutFN21_49-0\">\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 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=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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCLabSurv-50\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCLabSurv_50-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/wwwn.cdc.gov\/FoodNetFast\/LabSurvey\" target=\"_blank\">\"Diagnostic Laboratory Practices\"<\/a>. <i>FoodNet Fast<\/i>. Centers for Disease Control and Prevention. 23 September 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/wwwn.cdc.gov\/FoodNetFast\/LabSurvey\" target=\"_blank\">https:\/\/wwwn.cdc.gov\/FoodNetFast\/LabSurvey<\/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=Diagnostic+Laboratory+Practices&rft.atitle=FoodNet+Fast&rft.date=23+September+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwwwn.cdc.gov%2FFoodNetFast%2FLabSurvey&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230110190732\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.371 seconds\nReal time usage: 0.379 seconds\nPreprocessor visited node count: 37680\/1000000\nPost\u2010expand include size: 323929\/2097152 bytes\nTemplate argument size: 105385\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 97836\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 345.627 1 -total\n 91.95% 317.790 1 Template:Reflist\n 75.74% 261.768 50 Template:Citation\/core\n 36.54% 126.297 25 Template:Cite_web\n 28.35% 97.982 17 Template:Cite_book\n 11.74% 40.562 37 Template:Date\n 11.34% 39.184 6 Template:Cite_journal\n 8.03% 27.751 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\n 6.42% 22.177 2 Template:Citation\n 4.51% 15.591 35 Template:Citation\/identifier\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13925-0!canonical and timestamp 20230110190733 and revision id 50876. 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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_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>","4922bb8abd32879cd573c6f2886e1456_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/4\/49\/Food_lab_scientist_packages_food_for_spaceflight_at_Space_Food_Lab.jpg"],"4922bb8abd32879cd573c6f2886e1456_timestamp":1673378970,"d3d4b1f9f24fdaaf098de1fd6a9bc3e8_type":"article","d3d4b1f9f24fdaaf098de1fd6a9bc3e8_title":"1.1 Food and beverage labs, then and now","d3d4b1f9f24fdaaf098de1fd6a9bc3e8_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now","d3d4b1f9f24fdaaf098de1fd6a9bc3e8_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/Introduction to food and beverage laboratories\/Food and beverage labs, then and nowFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n1. Introduction to food and beverage laboratories \nFood and beverage laboratories help develop and ensure the safety and quality of the food, beverages, and nutritional supplements humans and animals consume. From creating new flavor enhancers for food to ensuring the quality and safe consumption of a wine, these labs play a vital role in most parts of the world where processed food and agricultural products are produced. These labs are found in the private, government, and academic sectors and provide many different services, including (but not limited to)[1]:\n\nreverse engineering,\nclaims testing,\ncontaminate testing,\nbatch variation testing,\nextractable and leachable testing,\nallergen testing,\nshelf life testing,\nnon-routine quality testing, and\npackaging testing.\nIf you have ever enjoyed a candy bar, soda, or snack cake, know that a laboratory and food scientists were behind its production. Even if you don't care much for such processed foods, a laboratory is still involved in the quality and safety testing of raw fruits and vegetables, milk, and nuts. And when food supplies become contaminated, government testing labs are often in the thick of determining the source of the contamination as quickly as possible before more people become ill.\nBut what of the history of the food and beverage 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 Food and beverage labs, then and now \nThe history of laboratory-based food and beverage tasting is a scattered one, with little being documented about foodborne illness and food safety until the nineteenth century. With a better understanding of bacteria and their relationship to disease, however, more was being said about the topic by the mid- to late-1800s.[2] 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.[3] \nRoughly around the same time, during the 1880s, Britain saw more public health awareness develop in regards to digestive bacterial infections. \"As deadlier infections retreated,\" argues social historian Anne Hardy, \"food poisoning became an increasing concern of local and national health authorities, who sought both to raise public awareness of the condition as illness, and to regulate and improve food handling practices.\"[4] This led to further efforts from public health laboratories to promote the reporting and tracking of food poisoning cases by the 1940s.[4] \nWith the recognition of bacterial and other forms of contamination occurring in foodstuffs, beverages, and ingredients, as well as growing acknowledgement of the detrimental health effects of dangerous adulterations with toxic substances, additional progress was made in the realm of regulating and testing produced food and beverages. Events of interest along the way include[5][6][7][8][9][10]:\n\nBy 1880, the first of many municipal laboratories dedicated to testing food and beverage adulteration came into use in France. A focus was made on watered-down wines early on, but Frances's municipal food safety labs quickly began addressing other foods, beverages, and ingredients.\nThe Pure Food and Drug Act and Beef Inspection Act were passed in 1906 in response to food quality issues in packing plants, on farms, and other areas of food production.\nIn 1927, the U.S. Food, Drug, and Insecticide Administration (shortened to the U.S. Food and Drug Administration or FDA not long after) was formed to better enforce the Pure Food Act.\nBy 1945, Clostridium perfringens was being identified as a common cause of foodborne illness[2], and today it is recognized by the Centers for Disease Control and Prevention (CDC) as one of the top five provocateurs of foodborne illness.[11]\nThe seeds of the hazard analysis and critical control points (HACCP) quality control method were planted in 1959, when Pillsbury began working with NASA to ensure safe foods for astronauts. The value of Pillsbury and NASA's methodology became apparent to the food and beverage industry by 1972, and other organizations began adopting HACCP for food safety.\nThe Fair Packaging and Labeling Act of 1966 brought standardized, more accurate labeling to food and beverages.\nThe Food Quality Protection Act of 1996 mandated HACCP for most food processors and improved pesticide level calculations.\nFDA Food Safety Modernization Act (FSMA) was enacted in 2011, giving the FDA more enforcement authority and tools to improve the backbone of the U.S. food and water supply.\nIn December 2021, the Laboratory Accreditation for Analyses of Foods (LAAF) amendment to the FSMA was approved, providing for an accreditation program for laboratories wanting to further participate in the critical role of ensuring the safety of the U.S. food supply through the \"testing of food in certain circumstances.\"\nThis progression of scientific discovery and regulatory action has surely managed to reduce risks to U.S. food and beverage consumers, though not without complication and complexity.[12][13] As the U.S. population has grown over the past 100 years, it has become more difficult to have a sufficient number of inspectors, for example, to examine every production facility or farm and all they do, necessitating a risk assessment approach to food and beverage safety.[6][7][14] As such, the laboratory is undoubtedly a critical component of risk-based safety assessments of food and beverage products.\n\nReferences \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 2.0 2.1 Roberts, Cynthia A. (2001). The food safety information handbook. Westport, CT: Oryx Press. pp. 25-28. ISBN 978-1-57356-305-5.   \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 4.0 4.1 Hardy, A. (1 August 1999). \"Food, Hygiene, and the Laboratory. A Short History of Food Poisoning in Britain, circa 1850-1950\" (in en). Social History of Medicine 12 (2): 293\u2013311. doi:10.1093\/shm\/12.2.293. ISSN 0951-631X. https:\/\/academic.oup.com\/shm\/article-lookup\/doi\/10.1093\/shm\/12.2.293 .   \n \n\n\u2191 Stanziani, A. (2016). \"Chapter 9. Municipal Laboratories and the Analysis of Foodstuffs in France Under the Third Republic: A Case Study of the Paris Municipal Laboratory, 1878-1907\". In Atkins, P.J.; Lummel, P.; Oddy, D.J. (in English). Food and the city in Europe since 1800. London; New York: Routledge. ISBN 978-1-315-58261-0. OCLC 950471625. https:\/\/books.google.com\/books?hl=en&lr=&id=OPYFDAAAQBAJ&oi=fnd&pg=PA105 .   \n \n\n\u2191 6.0 6.1 Redman, Nina (2007). \"Chapter 1: Background and History\". Food safety: a reference handbook. Contemporary world issues (2nd ed ed.). Santa Barbara, Calif: ABC-CLIO. ISBN 978-1-59884-048-3. OCLC ocm83609690. https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/ocm83609690 .   \n \n\n\u2191 7.0 7.1 Stevens, K.; Hood, S. (2019). \"Chapter 40. Food Safety Management Systems\". In Doyle, Michael P.; Diez-Gonzalez, Francisco; Hill, Colin. Food microbiology: fundamentals and frontiers (5th edition ed.). Washington, DC: ASM Press. pp. 1007-20. ISBN 978-1-55581-997-2.   \n \n\n\u2191 Detwiler, Darin S. (2020). \"Chapter 2: \"Modernization\" started over a century ago\". Food safety: past, present, and predictions. London [England] ; San Diego, CA: Academic Press. pp. 11-23. ISBN 978-0-12-818219-2.   \n \n\n\u2191 \"Background on the FDA Food Safety Modernization Act (FSMA)\". Food and Drug Administration. 30 January 2018. https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/background-fda-food-safety-modernization-act-fsma . Retrieved 07 December 2022 .   \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 \"Foodborne Germs and Illnesses\". Centers for Disease Control and Prevention. 18 March 2020. https:\/\/www.cdc.gov\/foodsafety\/foodborne-germs.html . Retrieved 07 December 2022 .   \n \n\n\u2191 Lytton, Timothy D. (2019). \"An Introduction to the Food Safety System\". Outbreak: Foodborne Illness and the Struggle for Food Safety. Chicago ; London: The University of Chicago Press. pp. 1-23. ISBN 978-0-226-61154-9.   \n \n\n\u2191 Floros, John D.; Newsome, Rosetta; Fisher, William; Barbosa-C\u00e1novas, Gustavo V.; Chen, Hongda; Dunne, C. Patrick; German, J. Bruce; Hall, Richard L. et al. (26 August 2010). \"Feeding the World Today and Tomorrow: The Importance of Food Science and Technology: An IFT Scientific Review\" (in en). Comprehensive Reviews in Food Science and Food Safety 9 (5): 572\u2013599. doi:10.1111\/j.1541-4337.2010.00127.x. https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1541-4337.2010.00127.x .   \n \n\n\u2191  Food Safety: Current Status and Future Needs. American Academy of Microbiology Colloquia Reports. Washington (DC): American Society for Microbiology. 1998. PMID 33001600. http:\/\/www.ncbi.nlm.nih.gov\/books\/NBK562616\/ .   \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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 19:06.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","d3d4b1f9f24fdaaf098de1fd6a9bc3e8_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Introduction_to_food_and_beverage_laboratories_Food_and_beverage_labs_then_and_now rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Introduction_to_food_and_beverage_laboratories_Food_and_beverage_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 Food Safety and Quality\/Introduction to food and beverage laboratories\/Food and beverage 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_Food_Safety_and_Quality\/Introduction\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction\" class=\"wiki-link\" data-key=\"0822452a7f1eedb289e5f215d84c8b5f\">the beginning<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"1._Introduction_to_food_and_beverage_laboratories\">1. Introduction to food and beverage laboratories<\/span><\/h2>\n<p>Food and beverage laboratories help develop and ensure the safety and quality of the food, beverages, and nutritional supplements humans and animals consume. From creating new flavor enhancers for food to ensuring the quality and safe consumption of a wine, these labs play a vital role in most parts of the world where processed food and agricultural products are produced. These labs are found in the private, government, and academic sectors and provide many different services, including (but not limited to)<sup id=\"rdp-ebb-cite_ref-NielsenFood15_1-0\" class=\"reference\"><a href=\"#cite_note-NielsenFood15-1\">[1]<\/a><\/sup>:\n<\/p>\n<ul><li>reverse engineering,<\/li>\n<li>claims testing,<\/li>\n<li>contaminate testing,<\/li>\n<li>batch variation testing,<\/li>\n<li>extractable and leachable testing,<\/li>\n<li>allergen testing,<\/li>\n<li>shelf life testing,<\/li>\n<li>non-routine quality testing, and<\/li>\n<li>packaging testing.<\/li><\/ul>\n<p>If you have ever enjoyed a candy bar, soda, or snack cake, know that a laboratory and food scientists were behind its production. Even if you don't care much for such processed foods, a laboratory is still involved in the quality and safety testing of raw fruits and vegetables, milk, and nuts. And when food supplies become contaminated, government testing labs are often in the thick of determining the source of the contamination as quickly as possible before more people become ill.\n<\/p><p>But what of the history of the food and beverage 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_Food_and_beverage_labs,_then_and_now\"><\/span><span class=\"mw-headline\" id=\"1.1_Food_and_beverage_labs.2C_then_and_now\">1.1 Food and beverage labs, then and now<\/span><\/h3>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:%E2%80%98A_Treatise_on_Adulterations_of_Food,_and_Culinary_Poisons%E2%80%99_by_Friedrich_Chritisan_Accum.jpg\" class=\"image wiki-link\" data-key=\"97b23d7bcef19252d3ba78e80b20213f\"><img alt=\"\u2018A Treatise on Adulterations of Food, and Culinary Poisons\u2019 by Friedrich Chritisan Accum.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/e\/ed\/%E2%80%98A_Treatise_on_Adulterations_of_Food%2C_and_Culinary_Poisons%E2%80%99_by_Friedrich_Chritisan_Accum.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>The history of laboratory-based food and beverage tasting is a scattered one, with little being documented about foodborne illness and food safety until the nineteenth century. With a better understanding of bacteria and their relationship to disease, however, more was being said about the topic by the mid- to late-1800s.<sup id=\"rdp-ebb-cite_ref-RobertsTheFood01_2-0\" class=\"reference\"><a href=\"#cite_note-RobertsTheFood01-2\">[2]<\/a><\/sup> 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-3\" class=\"reference\"><a href=\"#cite_note-3\">[3]<\/a><\/sup> \n<\/p><p>Roughly around the same time, during the 1880s, Britain saw more public health awareness develop in regards to digestive bacterial infections. \"As deadlier infections retreated,\" argues social historian Anne Hardy, \"food poisoning became an increasing concern of local and national health authorities, who sought both to raise public awareness of the condition as illness, and to regulate and improve food handling practices.\"<sup id=\"rdp-ebb-cite_ref-HardyFood99_4-0\" class=\"reference\"><a href=\"#cite_note-HardyFood99-4\">[4]<\/a><\/sup> This led to further efforts from public health laboratories to promote the reporting and tracking of food poisoning cases by the 1940s.<sup id=\"rdp-ebb-cite_ref-HardyFood99_4-1\" class=\"reference\"><a href=\"#cite_note-HardyFood99-4\">[4]<\/a><\/sup> \n<\/p><p>With the recognition of bacterial and other forms of contamination occurring in foodstuffs, beverages, and ingredients, as well as growing acknowledgement of the detrimental health effects of dangerous adulterations with toxic substances, additional progress was made in the realm of regulating and testing produced food and beverages. Events of interest along the way include<sup id=\"rdp-ebb-cite_ref-5\" class=\"reference\"><a href=\"#cite_note-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-:0_6-0\" class=\"reference\"><a href=\"#cite_note-:0-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-:1_7-0\" class=\"reference\"><a href=\"#cite_note-:1-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-8\" class=\"reference\"><a href=\"#cite_note-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FDABackFSMA18_9-0\" class=\"reference\"><a href=\"#cite_note-FDABackFSMA18-9\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DouglasFDA22_10-0\" class=\"reference\"><a href=\"#cite_note-DouglasFDA22-10\">[10]<\/a><\/sup>:\n<\/p>\n<ul><li>By 1880, the first of many municipal laboratories dedicated to testing food and beverage adulteration came into use in France. A focus was made on watered-down wines early on, but Frances's municipal food safety labs quickly began addressing other foods, beverages, and ingredients.<\/li>\n<li>The Pure Food and Drug Act and Beef Inspection Act were passed in 1906 in response to food quality issues in packing plants, on farms, and other areas of food production.<\/li>\n<li>In 1927, the U.S. Food, Drug, and Insecticide Administration (shortened to the U.S. Food and Drug Administration or FDA not long after) was formed to better enforce the Pure Food Act.<\/li>\n<li>By 1945, <i>Clostridium perfringens<\/i> was being identified as a common cause of foodborne illness<sup id=\"rdp-ebb-cite_ref-RobertsTheFood01_2-1\" class=\"reference\"><a href=\"#cite_note-RobertsTheFood01-2\">[2]<\/a><\/sup>, and today it is recognized by the <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Disease_Control_and_Prevention\" title=\"Centers for Disease Control and Prevention\" class=\"wiki-link\" data-key=\"176aa9c9513251c328d864d1e724e814\">Centers for Disease Control and Prevention<\/a> (CDC) as one of the top five provocateurs of foodborne illness.<sup id=\"rdp-ebb-cite_ref-CDCFood20_11-0\" class=\"reference\"><a href=\"#cite_note-CDCFood20-11\">[11]<\/a><\/sup><\/li>\n<li>The seeds of the hazard analysis and critical control points (HACCP) quality control method were planted in 1959, when Pillsbury began working with NASA to ensure safe foods for astronauts. The value of Pillsbury and NASA's methodology became apparent to the food and beverage industry by 1972, and other organizations began adopting HACCP for food safety.<\/li>\n<li>The Fair Packaging and Labeling Act of 1966 brought standardized, more accurate labeling to food and beverages.<\/li>\n<li>The Food Quality Protection Act of 1996 mandated HACCP for most food processors and improved pesticide level calculations.<\/li>\n<li>FDA Food Safety Modernization Act (FSMA) was enacted in 2011, giving the FDA more enforcement authority and tools to improve the backbone of the U.S. food and water supply.<\/li>\n<li>In December 2021, the Laboratory Accreditation for Analyses of Foods (LAAF) amendment to the FSMA was approved, providing for an accreditation program for laboratories wanting to further participate in the critical role of ensuring the safety of the U.S. food supply through the \"testing of food in certain circumstances.\"<\/li><\/ul>\n<p>This progression of scientific discovery and regulatory action has surely managed to reduce risks to U.S. food and beverage consumers, though not without complication and complexity.<sup id=\"rdp-ebb-cite_ref-LyttonAnIntro19_12-0\" class=\"reference\"><a href=\"#cite_note-LyttonAnIntro19-12\">[12]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-13\" class=\"reference\"><a href=\"#cite_note-13\">[13]<\/a><\/sup> As the U.S. population has grown over the past 100 years, it has become more difficult to have a sufficient number of inspectors, for example, to examine every production facility or farm and all they do, necessitating a risk assessment approach to food and beverage safety.<sup id=\"rdp-ebb-cite_ref-:0_6-1\" class=\"reference\"><a href=\"#cite_note-:0-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-:1_7-1\" class=\"reference\"><a href=\"#cite_note-:1-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-14\" class=\"reference\"><a href=\"#cite_note-14\">[14]<\/a><\/sup> As such, the laboratory is undoubtedly a critical component of risk-based safety assessments of food and beverage products.\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-NielsenFood15-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NielsenFood15_1-0\">\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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RobertsTheFood01-2\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-RobertsTheFood01_2-0\">2.0<\/a><\/sup> <sup><a href=\"#cite_ref-RobertsTheFood01_2-1\">2.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Roberts, Cynthia A. (2001). <i>The food safety information handbook<\/i>. Westport, CT: Oryx Press. pp. 25-28. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-1-57356-305-5.<\/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+food+safety+information+handbook&rft.aulast=Roberts&rft.aufirst=Cynthia+A.&rft.au=Roberts%2C%26%2332%3BCynthia+A.&rft.date=2001&rft.pages=pp.%26nbsp%3B25-28&rft.place=Westport%2C+CT&rft.pub=Oryx+Press&rft.isbn=978-1-57356-305-5&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_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\">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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HardyFood99-4\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HardyFood99_4-0\">4.0<\/a><\/sup> <sup><a href=\"#cite_ref-HardyFood99_4-1\">4.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Hardy, A. (1 August 1999). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/academic.oup.com\/shm\/article-lookup\/doi\/10.1093\/shm\/12.2.293\" target=\"_blank\">\"Food, Hygiene, and the Laboratory. A Short History of Food Poisoning in Britain, circa 1850-1950\"<\/a> (in en). <i>Social History of Medicine<\/i> <b>12<\/b> (2): 293\u2013311. <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%2Fshm%2F12.2.293\" target=\"_blank\">10.1093\/shm\/12.2.293<\/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\/0951-631X\" target=\"_blank\">0951-631X<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/academic.oup.com\/shm\/article-lookup\/doi\/10.1093\/shm\/12.2.293\" target=\"_blank\">https:\/\/academic.oup.com\/shm\/article-lookup\/doi\/10.1093\/shm\/12.2.293<\/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%2C+Hygiene%2C+and+the+Laboratory.+A+Short+History+of+Food+Poisoning+in+Britain%2C+circa+1850-1950&rft.jtitle=Social+History+of+Medicine&rft.aulast=Hardy&rft.aufirst=A.&rft.au=Hardy%2C%26%2332%3BA.&rft.date=1+August+1999&rft.volume=12&rft.issue=2&rft.pages=293%E2%80%93311&rft_id=info:doi\/10.1093%2Fshm%2F12.2.293&rft.issn=0951-631X&rft_id=https%3A%2F%2Facademic.oup.com%2Fshm%2Farticle-lookup%2Fdoi%2F10.1093%2Fshm%2F12.2.293&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_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 book\">Stanziani, A. (2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?hl=en&lr=&id=OPYFDAAAQBAJ&oi=fnd&pg=PA105\" target=\"_blank\">\"Chapter 9. Municipal Laboratories and the Analysis of Foodstuffs in France Under the Third Republic: A Case Study of the Paris Municipal Laboratory, 1878-1907\"<\/a>. In Atkins, P.J.; Lummel, P.; Oddy, D.J. (in English). <i>Food and the city in Europe since 1800<\/i>. London; New York: Routledge. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-1-315-58261-0. <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\/950471625\" target=\"_blank\">950471625<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?hl=en&lr=&id=OPYFDAAAQBAJ&oi=fnd&pg=PA105\" target=\"_blank\">https:\/\/books.google.com\/books?hl=en&lr=&id=OPYFDAAAQBAJ&oi=fnd&pg=PA105<\/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+9.+Municipal+Laboratories+and+the+Analysis+of+Foodstuffs+in+France+Under+the+Third+Republic%3A+A+Case+Study+of+the+Paris+Municipal+Laboratory%2C+1878-1907&rft.atitle=Food+and+the+city+in+Europe+since+1800&rft.aulast=Stanziani%2C+A.&rft.au=Stanziani%2C+A.&rft.date=2016&rft.place=London%3B+New+York&rft.pub=Routledge&rft.isbn=978-1-315-58261-0&rft_id=info:oclcnum\/950471625&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fhl%3Den%26lr%3D%26id%3DOPYFDAAAQBAJ%26oi%3Dfnd%26pg%3DPA105&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-:0-6\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-:0_6-0\">6.0<\/a><\/sup> <sup><a href=\"#cite_ref-:0_6-1\">6.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Redman, Nina (2007). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/ocm83609690\" target=\"_blank\">\"Chapter 1: Background and History\"<\/a>. <i>Food safety: a reference handbook<\/i>. Contemporary world issues (2nd ed ed.). Santa Barbara, Calif: ABC-CLIO. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-1-59884-048-3. <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\/ocm83609690\" target=\"_blank\">ocm83609690<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/ocm83609690\" target=\"_blank\">https:\/\/www.worldcat.org\/title\/mediawiki\/oclc\/ocm83609690<\/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+Background+and+History&rft.atitle=Food+safety%3A+a+reference+handbook&rft.aulast=Redman&rft.aufirst=Nina&rft.au=Redman%2C%26%2332%3BNina&rft.date=2007&rft.series=Contemporary+world+issues&rft.edition=2nd+ed&rft.place=Santa+Barbara%2C+Calif&rft.pub=ABC-CLIO&rft.isbn=978-1-59884-048-3&rft_id=info:oclcnum\/ocm83609690&rft_id=https%3A%2F%2Fwww.worldcat.org%2Ftitle%2Fmediawiki%2Foclc%2Focm83609690&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-:1-7\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-:1_7-0\">7.0<\/a><\/sup> <sup><a href=\"#cite_ref-:1_7-1\">7.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Stevens, K.; Hood, S. (2019). \"Chapter 40. Food Safety Management Systems\". In Doyle, Michael P.; Diez-Gonzalez, Francisco; Hill, Colin. <i>Food microbiology: fundamentals and frontiers<\/i> (5th edition ed.). Washington, DC: ASM Press. pp. 1007-20. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-1-55581-997-2.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+40.+Food+Safety+Management+Systems&rft.atitle=Food+microbiology%3A+fundamentals+and+frontiers&rft.aulast=Stevens%2C+K.%3B+Hood%2C+S.&rft.au=Stevens%2C+K.%3B+Hood%2C+S.&rft.date=2019&rft.pages=pp.%26nbsp%3B1007-20&rft.edition=5th+edition&rft.place=Washington%2C+DC&rft.pub=ASM+Press&rft.isbn=978-1-55581-997-2&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-8\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Detwiler, Darin S. (2020). \"Chapter 2: \"Modernization\" started over a century ago\". <i>Food safety: past, present, and predictions<\/i>. London [England] ; San Diego, CA: Academic Press. pp. 11-23. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 978-0-12-818219-2.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+2%3A+%22Modernization%22+started+over+a+century+ago&rft.atitle=Food+safety%3A+past%2C+present%2C+and+predictions&rft.aulast=Detwiler&rft.aufirst=Darin+S.&rft.au=Detwiler%2C%26%2332%3BDarin+S.&rft.date=2020&rft.pages=pp.%26nbsp%3B11-23&rft.place=London+%5BEngland%5D+%3B+San+Diego%2C+CA&rft.pub=Academic+Press&rft.isbn=978-0-12-818219-2&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FDABackFSMA18-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FDABackFSMA18_9-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/background-fda-food-safety-modernization-act-fsma\" target=\"_blank\">\"Background on the FDA Food Safety Modernization Act (FSMA)\"<\/a>. Food and Drug Administration. 30 January 2018<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/background-fda-food-safety-modernization-act-fsma\" target=\"_blank\">https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/background-fda-food-safety-modernization-act-fsma<\/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=Background+on+the+FDA+Food+Safety+Modernization+Act+%28FSMA%29&rft.atitle=&rft.date=30+January+2018&rft.pub=Food+and+Drug+Administration&rft_id=https%3A%2F%2Fwww.fda.gov%2Ffood%2Ffood-safety-modernization-act-fsma%2Fbackground-fda-food-safety-modernization-act-fsma&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DouglasFDA22-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DouglasFDA22_10-0\">\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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCFood20-11\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCFood20_11-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/foodsafety\/foodborne-germs.html\" target=\"_blank\">\"Foodborne Germs and Illnesses\"<\/a>. Centers for Disease Control and Prevention. 18 March 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/foodsafety\/foodborne-germs.html\" target=\"_blank\">https:\/\/www.cdc.gov\/foodsafety\/foodborne-germs.html<\/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=Foodborne+Germs+and+Illnesses&rft.atitle=&rft.date=18+March+2020&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Ffoodsafety%2Ffoodborne-germs.html&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LyttonAnIntro19-12\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LyttonAnIntro19_12-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Lytton, Timothy D. (2019). \"An Introduction to the Food Safety System\". <i>Outbreak: Foodborne Illness and the Struggle for Food Safety<\/i>. Chicago ; London: The University of Chicago Press. pp. 1-23. <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=An+Introduction+to+the+Food+Safety+System&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%3B1-23&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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\"><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 Journal\">Floros, John D.; Newsome, Rosetta; Fisher, William; Barbosa-C\u00e1novas, Gustavo V.; Chen, Hongda; Dunne, C. Patrick; German, J. Bruce; Hall, Richard L. <i>et al.<\/i> (26 August 2010). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1541-4337.2010.00127.x\" target=\"_blank\">\"Feeding the World Today and Tomorrow: The Importance of Food Science and Technology: An IFT Scientific Review\"<\/a> (in en). <i>Comprehensive Reviews in Food Science and Food Safety<\/i> <b>9<\/b> (5): 572\u2013599. <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\/10.1111%2Fj.1541-4337.2010.00127.x\" target=\"_blank\">10.1111\/j.1541-4337.2010.00127.x<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1541-4337.2010.00127.x\" target=\"_blank\">https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1541-4337.2010.00127.x<\/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=Feeding+the+World+Today+and+Tomorrow%3A+The+Importance+of+Food+Science+and+Technology%3A+An+IFT+Scientific+Review&rft.jtitle=Comprehensive+Reviews+in+Food+Science+and+Food+Safety&rft.aulast=Floros&rft.aufirst=John+D.&rft.au=Floros%2C%26%2332%3BJohn+D.&rft.au=Newsome%2C%26%2332%3BRosetta&rft.au=Fisher%2C%26%2332%3BWilliam&rft.au=Barbosa-C%C3%A1novas%2C%26%2332%3BGustavo+V.&rft.au=Chen%2C%26%2332%3BHongda&rft.au=Dunne%2C%26%2332%3BC.+Patrick&rft.au=German%2C%26%2332%3BJ.+Bruce&rft.au=Hall%2C%26%2332%3BRichard+L.&rft.au=Heldman%2C%26%2332%3BDennis+R.&rft.date=26+August+2010&rft.volume=9&rft.issue=5&rft.pages=572%E2%80%93599&rft_id=info:doi\/10.1111%2Fj.1541-4337.2010.00127.x&rft_id=https%3A%2F%2Fonlinelibrary.wiley.com%2Fdoi%2F10.1111%2Fj.1541-4337.2010.00127.x&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\"><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 book\"> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/books\/NBK562616\/\" target=\"_blank\"><i>Food Safety: Current Status and Future Needs<\/i><\/a>. American Academy of Microbiology Colloquia Reports. Washington (DC): American Society for Microbiology. 1998. <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\/33001600\" target=\"_blank\">33001600<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/books\/NBK562616\/\" target=\"_blank\">http:\/\/www.ncbi.nlm.nih.gov\/books\/NBK562616\/<\/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+Safety%3A+Current+Status+and+Future+Needs&rft.date=1998&rft.series=American+Academy+of+Microbiology+Colloquia+Reports&rft.place=Washington+%28DC%29&rft.pub=American+Society+for+Microbiology&rft_id=info:pmid\/33001600&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fbooks%2FNBK562616%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230110190612\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.128 seconds\nReal time usage: 0.134 seconds\nPreprocessor visited node count: 11228\/1000000\nPost\u2010expand include size: 93427\/2097152 bytes\nTemplate argument size: 29773\/2097152 bytes\nHighest expansion depth: 25\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 27166\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 119.893 1 -total\n 91.86% 110.129 1 Template:Reflist\n 70.17% 84.134 14 Template:Citation\/core\n 51.21% 61.394 9 Template:Cite_book\n 15.03% 18.020 3 Template:Cite_web\n 14.25% 17.079 2 Template:Cite_journal\n 11.81% 14.164 13 Template:Date\n 8.08% 9.688 1 Template:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\n 7.60% 9.111 14 Template:Citation\/identifier\n 4.25% 5.093 21 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:13924-0!canonical and timestamp 20230110190630 and revision id 50875. 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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_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>","d3d4b1f9f24fdaaf098de1fd6a9bc3e8_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/e\/ed\/%E2%80%98A_Treatise_on_Adulterations_of_Food%2C_and_Culinary_Poisons%E2%80%99_by_Friedrich_Chritisan_Accum.jpg"],"d3d4b1f9f24fdaaf098de1fd6a9bc3e8_timestamp":1673378970,"0822452a7f1eedb289e5f215d84c8b5f_type":"article","0822452a7f1eedb289e5f215d84c8b5f_title":"Introduction","0822452a7f1eedb289e5f215d84c8b5f_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction","0822452a7f1eedb289e5f215d84c8b5f_plaintext":"\n\nBook:LIMS Selection Guide for Food Safety and Quality\/IntroductionFrom LIMSWikiJump to navigationJump to search\nTitle: LIMS Selection Guide for Food Safety and Quality\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 2023\n\r\n\nThe laboratory information management system is a critical component of proper laboratory management and operations, including for the food and beverage industry. At stake is the safety and quality of foods and beverages, and by extension the wellbeing of millions of people, as well as the reputation of the businesses that produce the food and beverages. This guide recognizes the important role the food and beverage laboratory plays in our society towards food and beverage safety and quality, as well as the standards and regulations affecting these laboratories and their operations. It then addresses the role of laboratory informatics solutions like the LIMS and what the optimal feature set is for the industry. But acquiring a LIMS is more than just a selection process; there's more to take into consideration such as cybersecurity, regulatory controls, implementation procedures, and future service from the LIMS vendor. This considerations and more are addressed, followed by discussion of a requirements-based specification approach to ensuring your lab acquires the LIMS that best fits its needs.\nThe table of contents for LIMS Selection Guide for Food Safety and Quality is as follows:\n\r\n\n\n1. Introduction to food and beverage laboratories\n1.1 Food and beverage labs, then and now\n1.2 Laboratory roles and testing in the industry\n1.2.1 R&D roles and testing\n1.2.2 Pre-manufacturing and manufacturing roles and testing\n1.2.3 Post-production regulation and security roles and testing\n1.2.4 Tangential laboratory work<\/dd>\n1.3 Safety and quality in the food and beverage industry<\/dd>\n2. Standards and regulations affecting food and beverage labs\n2.1 Globally recognized food safety standards\n2.1.1 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)\n2.1.2 Codex Alimentarius\n2.1.3 Global Food Safety Initiative (GFSI)\n2.1.4 Hazard analysis and critical control points (HACCP)\n2.1.5 International Featured Standards (IFS)\n2.1.6 International Organization for Standardization (ISO) 22000\n2.1.8 Safe Quality Food (SQF) Program<\/dd>\n2.2 Regulations and laws around the world\n2.2.1 Food Safety Act 1990 and Food Standards Act 1999 - United Kingdom\n2.2.2 Food Safety and Standards Act of 2006 - India\n2.2.3 Food Safety Law - China\n2.2.4 Food Sanitation Act and Food Safety Basic Act - Japan\n2.2.5 Food Safety Modernization Act (FSMA) and other acts - United States\n2.2.6 General Food Law Regulation (GFLR) - European Union\n2.2.7 Safe Food for Canadians Act (SFCA) - Canada<\/dd>\n2.3 Other influencing factors\n2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)\n2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)<\/dd><\/dd>\n3. Choosing laboratory informatics software for your food and beverage 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 food and beverage 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\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction<\/a>\nCategory: LII:Guides, white papers, and other publicationsNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain 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\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 10 January 2023, at 18:51.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","0822452a7f1eedb289e5f215d84c8b5f_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_Introduction rootpage-Book_LIMS_Selection_Guide_for_Food_Safety_and_Quality_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 Food Safety and Quality\/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:Food_Safety_1.svg\" class=\"image wiki-link\" data-key=\"0ebeda06efefc989db575fb71fd3e85e\"><img alt=\"Food Safety 1.svg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/6\/6d\/Food_Safety_1.svg\/230px-Food_Safety_1.svg.png\" decoding=\"async\" width=\"230\" height=\"296\" \/><\/a><\/div>\n<p><b>Title<\/b>: <i>LIMS Selection Guide for Food Safety and Quality<\/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>: January 2023\n<\/p><p><br \/>\nThe <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> is a critical component of proper <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> management and operations, including for the food and beverage industry. At stake is the safety and quality of foods and beverages, and by extension the wellbeing of millions of people, as well as the reputation of the businesses that produce the food and beverages. This guide recognizes the important role the food and beverage laboratory plays in our society towards food and beverage safety and quality, as well as the standards and regulations affecting these laboratories and their operations. It then addresses the role of <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> solutions like the LIMS and what the optimal feature set is for the industry. But acquiring a LIMS is more than just a selection process; there's more to take into consideration such as cybersecurity, regulatory controls, implementation procedures, and future service from the LIMS vendor. This considerations and more are addressed, followed by discussion of a requirements-based specification approach to ensuring your lab acquires the LIMS that best fits its needs.\n<\/p><p>The table of contents for <i>LIMS Selection Guide for Food Safety and Quality<\/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_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Introduction to food and beverage laboratories\/Food and beverage labs, then and now\" class=\"wiki-link\" data-key=\"d3d4b1f9f24fdaaf098de1fd6a9bc3e8\">1. Introduction to food and beverage laboratories<\/a>\n<dl><dd>1.1 Food and beverage labs, then and now<\/dd>\n<dd>1.2 Laboratory roles and testing in the industry\n<dl><dd>1.2.1 R&D roles and testing<\/dd>\n<dd>1.2.2 Pre-manufacturing and manufacturing roles and testing<\/dd>\n<dd>1.2.3 Post-production regulation and security roles and testing<\/dd>\n<dd>1.2.4 Tangential laboratory work<\/dd><\/dl><\/dd>\n<dd>1.3 Safety and quality in the food and beverage industry<\/dd><\/dl><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Standards and regulations affecting food and beverage labs\/Globally recognized food safety standards\" class=\"wiki-link\" data-key=\"e3e9feec19733f9743b173dea0d9991c\">2. Standards and regulations affecting food and beverage labs<\/a>\n<dl><dd>2.1 Globally recognized food safety standards\n<dl><dd>2.1.1 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)<\/dd>\n<dd>2.1.2 Codex Alimentarius<\/dd>\n<dd>2.1.3 Global Food Safety Initiative (GFSI)<\/dd>\n<dd>2.1.4 Hazard analysis and critical control points (HACCP)<\/dd>\n<dd>2.1.5 International Featured Standards (IFS)<\/dd>\n<dd>2.1.6 International Organization for Standardization (ISO) 22000<\/dd>\n<dd>2.1.8 Safe Quality Food (SQF) Program<\/dd><\/dl><\/dd>\n<dd>2.2 Regulations and laws around the world\n<dl><dd>2.2.1 Food Safety Act 1990 and Food Standards Act 1999 - United Kingdom<\/dd>\n<dd>2.2.2 Food Safety and Standards Act of 2006 - India<\/dd>\n<dd>2.2.3 Food Safety Law - China<\/dd>\n<dd>2.2.4 Food Sanitation Act and Food Safety Basic Act - Japan<\/dd>\n<dd>2.2.5 Food Safety Modernization Act (FSMA) and other acts - United States<\/dd>\n<dd>2.2.6 General Food Law Regulation (GFLR) - European Union<\/dd>\n<dd>2.2.7 Safe Food for Canadians Act (SFCA) - Canada<\/dd><\/dl><\/dd>\n<dd>2.3 Other influencing factors\n<dl><dd>2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)<\/dd>\n<dd>2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)<\/dd><\/dl><\/dd><\/dl><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Choosing laboratory informatics software for your food and beverage lab\/Evaluation and selection\" class=\"wiki-link\" data-key=\"85c23189f7dd8f52181f96a16f048ed1\">3. Choosing laboratory informatics software for your food and beverage 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_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Resources for selecting and implementing informatics solutions\/LIMS vendors\" class=\"wiki-link\" data-key=\"13e646a1466068f9c15573c3a34ab4fd\">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_Food_Safety_and_Quality\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Taking the next step\/Conduct initial research into a specification document tailored to your lab's needs\" class=\"wiki-link\" data-key=\"4d7cd16b7d897aa048577bae7dba6366\">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_Food_Safety_and_Quality\/Closing_remarks\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Closing remarks\" class=\"wiki-link\" data-key=\"7b322bd7ed0b3f89e1f75dc9f1cb6229\">6. Closing remarks<\/a><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Introduction_and_methodology\" title=\"Book:LIMS Selection Guide for Food Safety and Quality\/Blank LIMSpec template for food and beverage labs\/Introduction and methodology\" class=\"wiki-link\" data-key=\"00d6be3534583868d1ee1319a770caf1\">Appendix 1. Blank LIMSpec template for food and beverage 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<!-- \nNewPP limit report\nCached time: 20230110192930\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.009 seconds\nReal time usage: 0.010 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:13922-0!canonical and timestamp 20230110192930 and revision id 50873. 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_Food_Safety_and_Quality\/Introduction\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/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>","0822452a7f1eedb289e5f215d84c8b5f_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/6\/6d\/Food_Safety_1.svg\/460px-Food_Safety_1.svg.png"],"0822452a7f1eedb289e5f215d84c8b5f_timestamp":1673378970,"816bc5ee048c8669f9d42b30425606b4":{"type":"chapter","title":"About this book","key":"816bc5ee048c8669f9d42b30425606b4"}},"link":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality","price_currency":"","price_amount":"","book_size":"","download_url":"https:\/\/www.limsforum.com?ebb_action=book_download&book_id=105590","language":"","cta_button_content":"","toc":[{"type":"chapter","name":"About this book","id":"816bc5ee048c8669f9d42b30425606b4","children":[{"type":"article","name":"Introduction","id":"0822452a7f1eedb289e5f215d84c8b5f","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction"}]},{"type":"chapter","name":"1. Introduction to food and beverage laboratories","id":"cea71b58ecfd16caa29a549a698e0627","children":[{"type":"article","name":"1.1 Food and beverage labs, then and now","id":"d3d4b1f9f24fdaaf098de1fd6a9bc3e8","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Food_and_beverage_labs,_then_and_now"},{"type":"article","name":"1.2 Laboratory roles and testing in the industry","id":"4922bb8abd32879cd573c6f2886e1456","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Laboratory_roles_and_testing_in_the_industry"},{"type":"article","name":"1.3 Safety and quality in the food and beverage industry","id":"18c2f1894d54c6a47eb76c2bace78144","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Introduction_to_food_and_beverage_laboratories\/Safety_and_quality_in_the_food_and_beverage_industry"}]},{"type":"chapter","name":"2. Standards and regulations affecting food and beverage labs","id":"6aa3224859862763eb875e59e6b729d9","children":[{"type":"article","name":"2.1 Globally recognized food safety standards","id":"e3e9feec19733f9743b173dea0d9991c","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Globally_recognized_food_safety_standards"},{"type":"article","name":"2.2 Regulations and laws around the world","id":"56966df6cf92be2a7ac590d34a57bd6e","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Regulations_and_laws_around_the_world"},{"type":"article","name":"2.3 Other influencing factors","id":"08f550c28fc5d4a453b2ab63b595ec29","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Standards_and_regulations_affecting_food_and_beverage_labs\/Other_influencing_factors"}]},{"type":"chapter","name":"3. Choosing laboratory informatics software for your food and beverage lab","id":"32dc3d92aa27dc6a6517bdec2a32442c","children":[{"type":"article","name":"3.1 Evaluation and selection","id":"85c23189f7dd8f52181f96a16f048ed1","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Evaluation_and_selection"},{"type":"article","name":"3.2 Implementation","id":"f040e0fcf8fe01d87aefc3592c454852","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/Implementation"},{"type":"article","name":"3.3 MSW, updates, and other contracted services","id":"ccc5e25aa4604bc93620e0c530d9cb6a","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_lab\/MSW,_updates,_and_other_contracted_services"},{"type":"article","name":"3.4 How a user requirements specification fits into the entire process (LIMSpec)","id":"3e174e8473680146231974161b92fbba","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Choosing_laboratory_informatics_software_for_your_food_and_beverage_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":"13e646a1466068f9c15573c3a34ab4fd","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMS_vendors"},{"type":"article","name":"4.2 Consultants","id":"f217eb3dd3e8aa5d58e3a21cebb43dc2","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/Consultants"},{"type":"article","name":"4.3 Professional","id":"b5f21c96d22edbed3dd48104bb1e20fe","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Resources_for_selecting_and_implementing_informatics_solutions\/Professional"},{"type":"article","name":"4.4 LIMSpec","id":"4bc6ec7c96895f5613ffc0594e209ce2","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/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":"4d7cd16b7d897aa048577bae7dba6366","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/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":"ec8c05877df5b9b8214a1ffbc6a0786d","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/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":"b5678217484c5c925b559de16b5f304d","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/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":"2db9c11a390ff38350adddca69c67fdd","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor"}]},{"type":"chapter","name":"6. 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Technology and performance improvements","id":"b32fbbb8a3c435b4d62249bf2a390c65","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Technology_and_performance_improvements"},{"type":"article","name":"A6. Security and integrity of systems and operations","id":"38b1284aaf25c5e7fc592f28df438e77","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Security_and_integrity_of_systems_and_operations"},{"type":"article","name":"A7. Putting those requirements to practical use and caveats","id":"e8f9af0e14860993c90c8fe5e1bbdda3","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Food_Safety_and_Quality\/Blank_LIMSpec_template_for_food_and_beverage_labs\/Putting_LIMSpec_to_Use"},{"type":"article","name":"A8. 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LIMS Selection Guide for Food Safety and Quality
First Edition
Editor: Shawn Douglas
Publisher: LabLynx Press
Copyright LabLynx Inc. All rights reserved.